Trial Outcomes & Findings for A Study of Danicopan in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration (NCT NCT05019521)
NCT ID: NCT05019521
Last Updated: 2025-09-05
Results Overview
FAF provides high-contrast retinal images particularly valuable for the detection of atrophic areas. FAF images of the study eye were taken and sent to the reading center for total GA lesion area measurement. The total GA lesion area (square millimeter \[mm\^2\]) was transformed into sqrt (millimeter \[mm\]). Greater area affected means a worse outcome than smaller area affected. The rate of change from Baseline (mm/year) for each treatment group was estimated based on the coefficients for time and the interaction of time and treatment from the mixed models for repeated measures (MMRM). MMRM analysis included the change from Baseline at post-baseline visit in the sqrt GA lesion area as dependent variable.
TERMINATED
PHASE2
365 participants
Baseline, Week 52
2025-09-05
Participant Flow
The study included 104-week Masked Treatment Period (Masked Placebo-controlled \[Primary Evaluation Period; up to 52 weeks\] and Masked Active Treatment \[Secondary Evaluation Period; Week 52 to Week 104\]). As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
For standardization purposes, the primary and secondary efficacy analyses were measured in the pre-specified study eye per individual participant. In this study, ocular assessments were performed in both eyes at Screening. The eye that met all eligibility criteria was designated as the study eye and the other eye was used as the fellow eye. If both eyes were eligible, the right eye was designated as the study eye.
Participant milestones
| Measure |
Danicopan 100 mg BID
Participants received danicopan 100 milligrams (mg) twice daily (BID) during the 104-week Masked Treatment Period.
|
Danicopan 200 mg BID
Participants received danicopan 200 mg BID during the 104-week Masked Treatment Period.
|
Danicopan 400 mg QD
Participants received danicopan 400 mg once daily (QD) during the 104-week Masked Treatment Period.
|
Placebo
Participants received matching placebo and were re-randomized to one of the active treatment groups at Week 52.
|
Placebo - Danicopan 100 mg BID
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 100 mg BID for the remainder of the study.
|
Placebo - Danicopan 200 mg BID
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 200 mg BID for the remainder of the study.
|
Placebo - Danicopan 400 mg QD
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
|---|---|---|---|---|---|---|---|
|
Primary Evaluation Period (52 Weeks)
STARTED
|
93
|
91
|
91
|
90
|
0
|
0
|
0
|
|
Primary Evaluation Period (52 Weeks)
Received at Least 1 Dose of Study Drug
|
93
|
91
|
91
|
90
|
0
|
0
|
0
|
|
Primary Evaluation Period (52 Weeks)
COMPLETED
|
73
|
67
|
73
|
70
|
0
|
0
|
0
|
|
Primary Evaluation Period (52 Weeks)
NOT COMPLETED
|
20
|
24
|
18
|
20
|
0
|
0
|
0
|
|
Secondary Evaluation Period (52 Weeks)
STARTED
|
73
|
67
|
73
|
0
|
24
|
23
|
23
|
|
Secondary Evaluation Period (52 Weeks)
Received at Least 1 Dose of Study Drug
|
73
|
67
|
73
|
0
|
24
|
23
|
23
|
|
Secondary Evaluation Period (52 Weeks)
COMPLETED
|
15
|
14
|
11
|
0
|
5
|
2
|
3
|
|
Secondary Evaluation Period (52 Weeks)
NOT COMPLETED
|
58
|
53
|
62
|
0
|
19
|
21
|
20
|
Reasons for withdrawal
| Measure |
Danicopan 100 mg BID
Participants received danicopan 100 milligrams (mg) twice daily (BID) during the 104-week Masked Treatment Period.
|
Danicopan 200 mg BID
Participants received danicopan 200 mg BID during the 104-week Masked Treatment Period.
|
Danicopan 400 mg QD
Participants received danicopan 400 mg once daily (QD) during the 104-week Masked Treatment Period.
|
Placebo
Participants received matching placebo and were re-randomized to one of the active treatment groups at Week 52.
|
Placebo - Danicopan 100 mg BID
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 100 mg BID for the remainder of the study.
|
Placebo - Danicopan 200 mg BID
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 200 mg BID for the remainder of the study.
|
Placebo - Danicopan 400 mg QD
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
|---|---|---|---|---|---|---|---|
|
Primary Evaluation Period (52 Weeks)
Adverse Event
|
7
|
9
|
8
|
4
|
0
|
0
|
0
|
|
Primary Evaluation Period (52 Weeks)
Investigator's Discretion
|
1
|
1
|
0
|
2
|
0
|
0
|
0
|
|
Primary Evaluation Period (52 Weeks)
Withdrawal by Subject
|
7
|
13
|
6
|
9
|
0
|
0
|
0
|
|
Primary Evaluation Period (52 Weeks)
Lost to Follow-up
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Primary Evaluation Period (52 Weeks)
Death
|
0
|
1
|
0
|
3
|
0
|
0
|
0
|
|
Primary Evaluation Period (52 Weeks)
Liver abnormalities meeting Hy's Law criteria
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Primary Evaluation Period (52 Weeks)
Other Than Specified
|
3
|
0
|
3
|
2
|
0
|
0
|
0
|
|
Secondary Evaluation Period (52 Weeks)
Adverse Event
|
2
|
3
|
2
|
0
|
0
|
0
|
3
|
|
Secondary Evaluation Period (52 Weeks)
Investigator's Discretion
|
1
|
2
|
1
|
0
|
0
|
0
|
1
|
|
Secondary Evaluation Period (52 Weeks)
Withdrawal by Subject
|
3
|
0
|
0
|
0
|
5
|
2
|
2
|
|
Secondary Evaluation Period (52 Weeks)
Lack of Efficacy
|
0
|
1
|
2
|
0
|
0
|
0
|
0
|
|
Secondary Evaluation Period (52 Weeks)
Death
|
0
|
1
|
1
|
0
|
1
|
0
|
0
|
|
Secondary Evaluation Period (52 Weeks)
Liver abnormalities meeting Hy's Law criteria
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Secondary Evaluation Period (52 Weeks)
Other Than Specified
|
3
|
1
|
3
|
0
|
0
|
1
|
0
|
|
Secondary Evaluation Period (52 Weeks)
Study Terminated by Sponsor
|
49
|
45
|
53
|
0
|
13
|
17
|
14
|
Baseline Characteristics
A Study of Danicopan in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
Baseline characteristics by cohort
| Measure |
Danicopan 100 mg BID
n=93 Participants
Participants received danicopan 100 mg BID during the 104-week Masked Treatment Period.
|
Danicopan 200 mg BID
n=91 Participants
Participants received danicopan 200 mg BID during the 104-week Masked Treatment Period.
|
Danicopan 400 mg QD
n=91 Participants
Participants received danicopan 400 mg QD during the 104-week Masked Treatment Period.
|
Placebo
n=90 Participants
Participants received matching placebo and were re-randomized to one of the active treatment groups at Week 52.
|
Total
n=365 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
77.0 years
STANDARD_DEVIATION 7.20 • n=5 Participants
|
76.0 years
STANDARD_DEVIATION 7.24 • n=7 Participants
|
77.8 years
STANDARD_DEVIATION 7.52 • n=5 Participants
|
77.8 years
STANDARD_DEVIATION 6.75 • n=4 Participants
|
77.1 years
STANDARD_DEVIATION 7.19 • n=21 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
251 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
114 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
75 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
75 Participants
n=4 Participants
|
308 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
14 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
77 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
76 Participants
n=4 Participants
|
312 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Not Reported
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 52Population: All participants in the FAS (all randomized participants who received at least 1 dose \[full or partial\] of study drug grouped by randomized treatment group) who had any post-baseline FAF GA lesion area data at the Week 52 analysis. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
FAF provides high-contrast retinal images particularly valuable for the detection of atrophic areas. FAF images of the study eye were taken and sent to the reading center for total GA lesion area measurement. The total GA lesion area (square millimeter \[mm\^2\]) was transformed into sqrt (millimeter \[mm\]). Greater area affected means a worse outcome than smaller area affected. The rate of change from Baseline (mm/year) for each treatment group was estimated based on the coefficients for time and the interaction of time and treatment from the mixed models for repeated measures (MMRM). MMRM analysis included the change from Baseline at post-baseline visit in the sqrt GA lesion area as dependent variable.
Outcome measures
| Measure |
Danicopan 100 mg BID
n=65 Participants
Participants received danicopan 100 mg BID during the 104-week Masked Treatment Period.
|
Danicopan 200 mg BID
n=62 Participants
Participants received danicopan 200 mg BID during the 104-week Masked Treatment Period.
|
Danicopan 400 mg QD
n=70 Participants
Participants received danicopan 400 mg QD during the 104-week Masked Treatment Period.
|
Placebo
n=66 Participants
Participants received matching placebo and were re-randomized to one of the active treatment groups at Week 52.
|
Placebo - Danicopan 200 mg BID
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 200 mg BID for the remainder of the study.
|
Placebo - Danicopan 400 mg QD
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
Placebo - Danicopan 400 mg QD
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 100 mg BID
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 100 mg BID for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 200 mg BID
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 200 mg BID for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 400 mg QD
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Rate of Change From Baseline to Week 52 in the Square Root (Sqrt) of Total Geographic Atrophy (GA) Lesion Area in the Study Eye as Measured by Fundus Autofluorescence (FAF)
|
0.465 mm/year
Standard Error 0.0289
|
0.391 mm/year
Standard Error 0.0306
|
0.443 mm/year
Standard Error 0.0301
|
0.406 mm/year
Standard Error 0.0304
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 104Population: All participants in the FAS (all randomized participants who received at least 1 dose \[full or partial\] of study drug grouped by randomized treatment group) with both baseline visit and post-baseline (Week 104) visit FAF GA lesion area data. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
FAF provides high-contrast retinal images particularly valuable for the detection of atrophic areas. FAF images of the study eye were taken and sent to the reading center for total GA lesion area measurement. The total GA lesion area (mm\^2) was transformed into sqrt (mm). Greater area affected means a worse outcome than smaller area affected.
Outcome measures
| Measure |
Danicopan 100 mg BID
n=18 Participants
Participants received danicopan 100 mg BID during the 104-week Masked Treatment Period.
|
Danicopan 200 mg BID
n=13 Participants
Participants received danicopan 200 mg BID during the 104-week Masked Treatment Period.
|
Danicopan 400 mg QD
n=18 Participants
Participants received danicopan 400 mg QD during the 104-week Masked Treatment Period.
|
Placebo
n=6 Participants
Participants received matching placebo and were re-randomized to one of the active treatment groups at Week 52.
|
Placebo - Danicopan 200 mg BID
n=4 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 200 mg BID for the remainder of the study.
|
Placebo - Danicopan 400 mg QD
n=4 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
Placebo - Danicopan 400 mg QD
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 100 mg BID
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 100 mg BID for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 200 mg BID
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 200 mg BID for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 400 mg QD
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to Week 104 in the Sqrt of the Total GA Lesion Area in the Study Eye as Measured by FAF
|
0.892 mm
Standard Deviation 0.4545
|
0.705 mm
Standard Deviation 0.3831
|
0.859 mm
Standard Deviation 0.3468
|
0.668 mm
Standard Deviation 0.4866
|
0.585 mm
Standard Deviation 0.1396
|
0.787 mm
Standard Deviation 0.1858
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 52 and Week 104Population: All participants in the FAS (all randomized participants who received at least 1 dose \[full or partial\] of study drug grouped by randomized treatment group) with both baseline and post-baseline (Week 52 and Week 104) visit FAF GA lesion area data. As prespecified, data were collected and reported for participants. Therefore, 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated. Number analyzed = participants evaluable at specified timepoints.
FAF provides high-contrast retinal images particularly valuable for the detection of atrophic areas. FAF images of the study eye were taken and sent to the reading center for total GA lesion area (mm\^2) measurement. Greater area affected means a worse outcome than smaller area affected.
Outcome measures
| Measure |
Danicopan 100 mg BID
n=65 Participants
Participants received danicopan 100 mg BID during the 104-week Masked Treatment Period.
|
Danicopan 200 mg BID
n=62 Participants
Participants received danicopan 200 mg BID during the 104-week Masked Treatment Period.
|
Danicopan 400 mg QD
n=70 Participants
Participants received danicopan 400 mg QD during the 104-week Masked Treatment Period.
|
Placebo
n=66 Participants
Participants received matching placebo and were re-randomized to one of the active treatment groups at Week 52.
|
Placebo - Danicopan 200 mg BID
n=24 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 200 mg BID for the remainder of the study.
|
Placebo - Danicopan 400 mg QD
n=20 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
Placebo - Danicopan 400 mg QD
n=22 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 100 mg BID
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 100 mg BID for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 200 mg BID
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 200 mg BID for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 400 mg QD
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to Week 52 and Week 104 in the Total GA Lesion Area in the Study Eye as Measured by FAF
Change at Week 52
|
2.347 mm^2
Standard Deviation 1.2972
|
2.044 mm^2
Standard Deviation 1.2280
|
2.274 mm^2
Standard Deviation 1.4482
|
2.057 mm^2
Standard Deviation 1.2016
|
1.887 mm^2
Standard Deviation 1.1212
|
1.716 mm^2
Standard Deviation 0.9095
|
2.553 mm^2
Standard Deviation 1.3938
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in the Total GA Lesion Area in the Study Eye as Measured by FAF
Change at Week 104
|
4.311 mm^2
Standard Deviation 2.8803
|
3.223 mm^2
Standard Deviation 2.3784
|
4.504 mm^2
Standard Deviation 2.1300
|
—
|
3.309 mm^2
Standard Deviation 2.5878
|
3.653 mm^2
Standard Deviation 2.3125
|
5.098 mm^2
Standard Deviation 1.8250
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 52 and Week 104Population: All participants in the FAS (all randomized participants who received at least 1 dose \[full or partial\] of study drug grouped by randomized treatment group) with both baseline and post-baseline (Week 52 and Week 104) visit SD-OCT data. As prespecified, data were collected and reported for participants. Therefore, 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated. Number analyzed = participants evaluable for specified categories.
Photoreceptor loss was assessed by measuring the percent of macular EZ total attenuation using SD-OCT. The EZ was considered to be formed mainly by mitochondria within the ellipsoid layer of the outer portion of the inner segments of the photoreceptors. In SD-OCT, decreases in the integrity and intensity of the EZ have been correlated with the reduction in cone photoreceptors and retinal sensitivity in retinal degenerative diseases. Lower increase in percentage means a better outcome. Higher increase in percentage means a worse outcome.
Outcome measures
| Measure |
Danicopan 100 mg BID
n=72 Participants
Participants received danicopan 100 mg BID during the 104-week Masked Treatment Period.
|
Danicopan 200 mg BID
n=65 Participants
Participants received danicopan 200 mg BID during the 104-week Masked Treatment Period.
|
Danicopan 400 mg QD
n=72 Participants
Participants received danicopan 400 mg QD during the 104-week Masked Treatment Period.
|
Placebo
n=70 Participants
Participants received matching placebo and were re-randomized to one of the active treatment groups at Week 52.
|
Placebo - Danicopan 200 mg BID
n=24 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 200 mg BID for the remainder of the study.
|
Placebo - Danicopan 400 mg QD
n=23 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
Placebo - Danicopan 400 mg QD
n=23 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 100 mg BID
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 100 mg BID for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 200 mg BID
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 200 mg BID for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 400 mg QD
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to Week 52 and Week 104 in Percent Macular Ellipsoid Zone (EZ) Total Attenuation in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by Spectral-domain Optical Coherence Tomography (SD-OCT)
Study Eye: Change at Week 52
|
8.70 percentage of EZ total attenuation
Standard Deviation 4.681
|
7.48 percentage of EZ total attenuation
Standard Deviation 4.226
|
8.66 percentage of EZ total attenuation
Standard Deviation 4.633
|
7.50 percentage of EZ total attenuation
Standard Deviation 4.814
|
6.03 percentage of EZ total attenuation
Standard Deviation 3.147
|
7.74 percentage of EZ total attenuation
Standard Deviation 4.469
|
8.77 percentage of EZ total attenuation
Standard Deviation 6.206
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Percent Macular Ellipsoid Zone (EZ) Total Attenuation in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by Spectral-domain Optical Coherence Tomography (SD-OCT)
Study Eye: Change at Week 104
|
13.54 percentage of EZ total attenuation
Standard Deviation 7.664
|
11.72 percentage of EZ total attenuation
Standard Deviation 7.976
|
15.27 percentage of EZ total attenuation
Standard Deviation 6.156
|
—
|
10.81 percentage of EZ total attenuation
Standard Deviation 6.514
|
12.65 percentage of EZ total attenuation
Standard Deviation 5.163
|
14.76 percentage of EZ total attenuation
Standard Deviation 6.672
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Percent Macular Ellipsoid Zone (EZ) Total Attenuation in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by Spectral-domain Optical Coherence Tomography (SD-OCT)
Fellow Eye: Change at Week 52
|
6.31 percentage of EZ total attenuation
Standard Deviation 3.642
|
5.53 percentage of EZ total attenuation
Standard Deviation 3.665
|
6.96 percentage of EZ total attenuation
Standard Deviation 4.684
|
7.87 percentage of EZ total attenuation
Standard Deviation 4.790
|
7.31 percentage of EZ total attenuation
Standard Deviation 4.898
|
7.26 percentage of EZ total attenuation
Standard Deviation 4.164
|
8.94 percentage of EZ total attenuation
Standard Deviation 5.205
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Percent Macular Ellipsoid Zone (EZ) Total Attenuation in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by Spectral-domain Optical Coherence Tomography (SD-OCT)
Fellow Eye: Change at Week 104
|
12.80 percentage of EZ total attenuation
Standard Deviation 7.605
|
9.48 percentage of EZ total attenuation
Standard Deviation 5.396
|
14.05 percentage of EZ total attenuation
Standard Deviation 9.509
|
—
|
11.82 percentage of EZ total attenuation
Standard Deviation 9.719
|
12.34 percentage of EZ total attenuation
Standard Deviation 5.174
|
14.19 percentage of EZ total attenuation
Standard Deviation 3.223
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Percent Macular Ellipsoid Zone (EZ) Total Attenuation in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by Spectral-domain Optical Coherence Tomography (SD-OCT)
Both Eyes Combined: Change at Week 52
|
13.77 percentage of EZ total attenuation
Standard Deviation 7.285
|
11.27 percentage of EZ total attenuation
Standard Deviation 6.892
|
14.94 percentage of EZ total attenuation
Standard Deviation 8.335
|
14.02 percentage of EZ total attenuation
Standard Deviation 8.564
|
12.17 percentage of EZ total attenuation
Standard Deviation 7.625
|
13.43 percentage of EZ total attenuation
Standard Deviation 7.072
|
16.55 percentage of EZ total attenuation
Standard Deviation 10.412
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Percent Macular Ellipsoid Zone (EZ) Total Attenuation in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by Spectral-domain Optical Coherence Tomography (SD-OCT)
Both Eyes Combined: Change at Week 104
|
22.18 percentage of EZ total attenuation
Standard Deviation 15.324
|
17.17 percentage of EZ total attenuation
Standard Deviation 13.337
|
28.51 percentage of EZ total attenuation
Standard Deviation 12.937
|
—
|
20.65 percentage of EZ total attenuation
Standard Deviation 15.245
|
22.53 percentage of EZ total attenuation
Standard Deviation 7.748
|
28.95 percentage of EZ total attenuation
Standard Deviation 7.702
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 52 and Week 104Population: All participants in the FAS (all randomized participants who received at least 1 dose \[full or partial\] of study drug grouped by randomized treatment group) with both baseline and post-baseline (Week 52 and Week 104) visit SD-OCT data. As prespecified, data were collected and reported for participants. Therefore, 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated. Number analyzed = participants evaluable for specified categories.
Photoreceptor degradation was assessed by measuring the percent of macular EZ partial attenuation using SD-OCT. The EZ was considered to be formed mainly by mitochondria within the ellipsoid layer of the outer portion of the inner segments of the photoreceptors. In SD-OCT, decreases in the integrity and intensity of the EZ have been correlated with the reduction in cone photoreceptors and retinal sensitivity in retinal degenerative diseases. Lower increase in percentage means a better outcome. Higher increase in percentage means a worse outcome.
Outcome measures
| Measure |
Danicopan 100 mg BID
n=72 Participants
Participants received danicopan 100 mg BID during the 104-week Masked Treatment Period.
|
Danicopan 200 mg BID
n=65 Participants
Participants received danicopan 200 mg BID during the 104-week Masked Treatment Period.
|
Danicopan 400 mg QD
n=72 Participants
Participants received danicopan 400 mg QD during the 104-week Masked Treatment Period.
|
Placebo
n=70 Participants
Participants received matching placebo and were re-randomized to one of the active treatment groups at Week 52.
|
Placebo - Danicopan 200 mg BID
n=24 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 200 mg BID for the remainder of the study.
|
Placebo - Danicopan 400 mg QD
n=23 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
Placebo - Danicopan 400 mg QD
n=23 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 100 mg BID
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 100 mg BID for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 200 mg BID
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 200 mg BID for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 400 mg QD
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to Week 52 and Week 104 in Percent Macular EZ Partial Attenuation in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT
Study Eye: Change at Week 52
|
6.42 percentage of EZ partial attenuation
Standard Deviation 4.917
|
5.15 percentage of EZ partial attenuation
Standard Deviation 3.806
|
6.63 percentage of EZ partial attenuation
Standard Deviation 4.599
|
5.65 percentage of EZ partial attenuation
Standard Deviation 4.365
|
4.00 percentage of EZ partial attenuation
Standard Deviation 3.423
|
5.54 percentage of EZ partial attenuation
Standard Deviation 4.089
|
7.49 percentage of EZ partial attenuation
Standard Deviation 4.946
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Percent Macular EZ Partial Attenuation in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT
Fellow Eye: Change at Week 52
|
5.74 percentage of EZ partial attenuation
Standard Deviation 4.531
|
4.28 percentage of EZ partial attenuation
Standard Deviation 3.646
|
5.61 percentage of EZ partial attenuation
Standard Deviation 4.987
|
6.31 percentage of EZ partial attenuation
Standard Deviation 4.370
|
4.90 percentage of EZ partial attenuation
Standard Deviation 3.399
|
5.83 percentage of EZ partial attenuation
Standard Deviation 4.616
|
8.15 percentage of EZ partial attenuation
Standard Deviation 4.563
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Percent Macular EZ Partial Attenuation in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT
Study Eye: Change at Week 104
|
12.48 percentage of EZ partial attenuation
Standard Deviation 7.290
|
8.06 percentage of EZ partial attenuation
Standard Deviation 6.728
|
13.87 percentage of EZ partial attenuation
Standard Deviation 7.495
|
—
|
7.75 percentage of EZ partial attenuation
Standard Deviation 4.677
|
10.55 percentage of EZ partial attenuation
Standard Deviation 7.536
|
10.56 percentage of EZ partial attenuation
Standard Deviation 6.122
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Percent Macular EZ Partial Attenuation in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT
Fellow Eye: Change at Week 104
|
11.09 percentage of EZ partial attenuation
Standard Deviation 6.771
|
7.87 percentage of EZ partial attenuation
Standard Deviation 5.927
|
13.79 percentage of EZ partial attenuation
Standard Deviation 9.773
|
—
|
6.20 percentage of EZ partial attenuation
Standard Deviation 6.897
|
11.52 percentage of EZ partial attenuation
Standard Deviation 8.433
|
13.48 percentage of EZ partial attenuation
Standard Deviation 3.926
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Percent Macular EZ Partial Attenuation in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT
Both Eyes Combined: Change at Week 52
|
11.10 percentage of EZ partial attenuation
Standard Deviation 8.110
|
8.10 percentage of EZ partial attenuation
Standard Deviation 5.976
|
11.69 percentage of EZ partial attenuation
Standard Deviation 8.277
|
10.90 percentage of EZ partial attenuation
Standard Deviation 7.617
|
8.11 percentage of EZ partial attenuation
Standard Deviation 5.784
|
10.10 percentage of EZ partial attenuation
Standard Deviation 6.989
|
14.60 percentage of EZ partial attenuation
Standard Deviation 8.644
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Percent Macular EZ Partial Attenuation in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT
Both Eyes Combined: Change at Week 104
|
19.85 percentage of EZ partial attenuation
Standard Deviation 14.357
|
12.67 percentage of EZ partial attenuation
Standard Deviation 10.789
|
26.92 percentage of EZ partial attenuation
Standard Deviation 14.542
|
—
|
12.92 percentage of EZ partial attenuation
Standard Deviation 10.399
|
19.77 percentage of EZ partial attenuation
Standard Deviation 11.361
|
24.04 percentage of EZ partial attenuation
Standard Deviation 8.185
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 52 and Week 104Population: All participants in FAS (all randomized participants who received at least 1 dose \[full or partial\] of study drug grouped by randomized treatment) with both baseline and post-baseline (Week 52 and Week 104) visit ONL-RPE mean central 1 mm subfield thickness data. As prespecified, data were collected and reported for participants. Hence, 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated. Number analyzed = participants evaluable for specified categories.
The ONL - RPE mean central 1 mm subfield thickness refers to the average thickness of the retinal layers between the ONL and RPE measured within a 1 mm radius from the foveal center (the central point of the retina).
Outcome measures
| Measure |
Danicopan 100 mg BID
n=72 Participants
Participants received danicopan 100 mg BID during the 104-week Masked Treatment Period.
|
Danicopan 200 mg BID
n=65 Participants
Participants received danicopan 200 mg BID during the 104-week Masked Treatment Period.
|
Danicopan 400 mg QD
n=72 Participants
Participants received danicopan 400 mg QD during the 104-week Masked Treatment Period.
|
Placebo
n=70 Participants
Participants received matching placebo and were re-randomized to one of the active treatment groups at Week 52.
|
Placebo - Danicopan 200 mg BID
n=24 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 200 mg BID for the remainder of the study.
|
Placebo - Danicopan 400 mg QD
n=23 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
Placebo - Danicopan 400 mg QD
n=23 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 100 mg BID
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 100 mg BID for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 200 mg BID
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 200 mg BID for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 400 mg QD
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to Week 52 and Week 104 in Outer Nuclear Layer (ONL) - Retinal Pigment Epithelium (RPE) Mean Central 1 mm Subfield Thickness in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT
Study Eye: Change at Week 52
|
-4.60 micrometers (µm)
Standard Deviation 13.366
|
-4.48 micrometers (µm)
Standard Deviation 13.398
|
-4.86 micrometers (µm)
Standard Deviation 13.345
|
-3.10 micrometers (µm)
Standard Deviation 10.666
|
-0.51 micrometers (µm)
Standard Deviation 10.404
|
-2.53 micrometers (µm)
Standard Deviation 8.417
|
-6.41 micrometers (µm)
Standard Deviation 12.496
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Outer Nuclear Layer (ONL) - Retinal Pigment Epithelium (RPE) Mean Central 1 mm Subfield Thickness in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT
Study Eye: Change at Week 104
|
-12.63 micrometers (µm)
Standard Deviation 23.455
|
-10.01 micrometers (µm)
Standard Deviation 29.953
|
-12.47 micrometers (µm)
Standard Deviation 23.648
|
—
|
-22.77 micrometers (µm)
Standard Deviation 38.733
|
-14.72 micrometers (µm)
Standard Deviation 14.931
|
-12.76 micrometers (µm)
Standard Deviation 15.206
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Outer Nuclear Layer (ONL) - Retinal Pigment Epithelium (RPE) Mean Central 1 mm Subfield Thickness in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT
Fellow Eye: Change at Week 52
|
-7.83 micrometers (µm)
Standard Deviation 13.457
|
-4.65 micrometers (µm)
Standard Deviation 12.206
|
-7.63 micrometers (µm)
Standard Deviation 15.236
|
-7.63 micrometers (µm)
Standard Deviation 15.088
|
-4.69 micrometers (µm)
Standard Deviation 13.097
|
-9.01 micrometers (µm)
Standard Deviation 17.029
|
-9.39 micrometers (µm)
Standard Deviation 15.478
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Outer Nuclear Layer (ONL) - Retinal Pigment Epithelium (RPE) Mean Central 1 mm Subfield Thickness in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT
Fellow Eye: Change at Week 104
|
-13.84 micrometers (µm)
Standard Deviation 25.155
|
-12.00 micrometers (µm)
Standard Deviation 6.459
|
-16.53 micrometers (µm)
Standard Deviation 25.363
|
—
|
-14.28 micrometers (µm)
Standard Deviation 14.915
|
-26.53 micrometers (µm)
Standard Deviation 10.412
|
-26.32 micrometers (µm)
Standard Deviation 18.045
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Outer Nuclear Layer (ONL) - Retinal Pigment Epithelium (RPE) Mean Central 1 mm Subfield Thickness in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT
Both Eyes Combined: Change at Week 52
|
-11.16 micrometers (µm)
Standard Deviation 16.448
|
-7.77 micrometers (µm)
Standard Deviation 18.785
|
-11.75 micrometers (µm)
Standard Deviation 21.771
|
-9.55 micrometers (µm)
Standard Deviation 20.028
|
-4.60 micrometers (µm)
Standard Deviation 19.446
|
-9.57 micrometers (µm)
Standard Deviation 19.250
|
-14.70 micrometers (µm)
Standard Deviation 20.919
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Outer Nuclear Layer (ONL) - Retinal Pigment Epithelium (RPE) Mean Central 1 mm Subfield Thickness in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT
Both Eyes Combined: Change at Week 104
|
-22.29 micrometers (µm)
Standard Deviation 31.682
|
-17.78 micrometers (µm)
Standard Deviation 28.793
|
-28.34 micrometers (µm)
Standard Deviation 39.848
|
—
|
-34.67 micrometers (µm)
Standard Deviation 50.039
|
-35.94 micrometers (µm)
Standard Deviation 25.831
|
-39.08 micrometers (µm)
Standard Deviation 32.217
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 52 and Week 104Population: All participants in FAS (all randomized participants who received at least 1 dose \[full or partial\] of study drug grouped by randomized treatment) with both baseline and post-baseline (Week 52 and Week 104) visit ONL-RPE mean central macular 2 mm thickness data. As prespecified, data were collected and reported for participants. Therefore, 'Ns' reported below= number of participants analyzed regardless of which eye was evaluated. Number analyzed = participants evaluable for specified categories.
The ONL - RPE mean central macular 2 mm subfield thickness refers to the thickness of the retina in the central part of the macula, specifically within a 2 mm radius.
Outcome measures
| Measure |
Danicopan 100 mg BID
n=72 Participants
Participants received danicopan 100 mg BID during the 104-week Masked Treatment Period.
|
Danicopan 200 mg BID
n=65 Participants
Participants received danicopan 200 mg BID during the 104-week Masked Treatment Period.
|
Danicopan 400 mg QD
n=72 Participants
Participants received danicopan 400 mg QD during the 104-week Masked Treatment Period.
|
Placebo
n=70 Participants
Participants received matching placebo and were re-randomized to one of the active treatment groups at Week 52.
|
Placebo - Danicopan 200 mg BID
n=24 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 200 mg BID for the remainder of the study.
|
Placebo - Danicopan 400 mg QD
n=23 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
Placebo - Danicopan 400 mg QD
n=23 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 100 mg BID
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 100 mg BID for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 200 mg BID
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 200 mg BID for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 400 mg QD
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to Week 52 and Week 104 in ONL-RPE Mean Central Macular 2 mm Subfield Thickness in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT
Study Eye: Change at Week 52
|
-7.42 µm
Standard Deviation 7.354
|
-6.56 µm
Standard Deviation 9.960
|
-8.04 µm
Standard Deviation 8.589
|
-7.25 µm
Standard Deviation 7.219
|
-4.85 µm
Standard Deviation 6.749
|
-7.53 µm
Standard Deviation 6.631
|
-9.46 µm
Standard Deviation 7.805
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in ONL-RPE Mean Central Macular 2 mm Subfield Thickness in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT
Study Eye: Change at Week 104
|
-17.49 µm
Standard Deviation 14.707
|
-12.09 µm
Standard Deviation 21.562
|
-15.47 µm
Standard Deviation 11.523
|
—
|
-21.03 µm
Standard Deviation 23.221
|
-14.62 µm
Standard Deviation 6.409
|
-19.46 µm
Standard Deviation 11.807
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in ONL-RPE Mean Central Macular 2 mm Subfield Thickness in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT
Fellow Eye: Change at Week 52
|
-8.39 µm
Standard Deviation 8.989
|
-5.91 µm
Standard Deviation 9.783
|
-9.01 µm
Standard Deviation 8.981
|
-7.92 µm
Standard Deviation 9.205
|
-7.28 µm
Standard Deviation 7.784
|
-7.04 µm
Standard Deviation 7.522
|
-9.32 µm
Standard Deviation 11.750
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in ONL-RPE Mean Central Macular 2 mm Subfield Thickness in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT
Fellow Eye: Change at Week 104
|
-14.66 µm
Standard Deviation 14.939
|
-14.86 µm
Standard Deviation 11.321
|
-17.60 µm
Standard Deviation 10.975
|
—
|
-13.48 µm
Standard Deviation 10.615
|
-16.20 µm
Standard Deviation 4.746
|
-20.98 µm
Standard Deviation 12.521
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in ONL-RPE Mean Central Macular 2 mm Subfield Thickness in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT
Both Eyes Combined: Change at Week 52
|
-14.33 µm
Standard Deviation 11.799
|
-10.74 µm
Standard Deviation 14.465
|
-16.18 µm
Standard Deviation 13.333
|
-13.83 µm
Standard Deviation 12.378
|
-11.01 µm
Standard Deviation 11.299
|
-13.05 µm
Standard Deviation 9.983
|
-17.56 µm
Standard Deviation 14.952
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in ONL-RPE Mean Central Macular 2 mm Subfield Thickness in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT
Both Eyes Combined: Change at Week 104
|
-27.07 µm
Standard Deviation 19.859
|
-21.71 µm
Standard Deviation 24.931
|
-32.26 µm
Standard Deviation 19.723
|
—
|
-32.27 µm
Standard Deviation 31.178
|
-27.58 µm
Standard Deviation 13.280
|
-40.44 µm
Standard Deviation 23.788
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 52 and Week 104Population: All participants in the FAS (all randomized participants who received at least 1 dose \[full or partial\] of study drug grouped by randomized treatment group) with both baseline and post-baseline (Week 52 and Week 104) visit EZ-RPE macular volume data. As prespecified, data were collected and reported for participants. Therefore, 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated. Number analyzed = participants evaluable for specified categories.
The EZ - RPE macular volume refers to the volume of the retinal tissue between the EZ and the RPE, specifically within the macular region. Changes in EZ-RPE volume indicate the presence or progression of diseases affecting the outer retina.
Outcome measures
| Measure |
Danicopan 100 mg BID
n=72 Participants
Participants received danicopan 100 mg BID during the 104-week Masked Treatment Period.
|
Danicopan 200 mg BID
n=65 Participants
Participants received danicopan 200 mg BID during the 104-week Masked Treatment Period.
|
Danicopan 400 mg QD
n=72 Participants
Participants received danicopan 400 mg QD during the 104-week Masked Treatment Period.
|
Placebo
n=70 Participants
Participants received matching placebo and were re-randomized to one of the active treatment groups at Week 52.
|
Placebo - Danicopan 200 mg BID
n=24 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 200 mg BID for the remainder of the study.
|
Placebo - Danicopan 400 mg QD
n=23 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
Placebo - Danicopan 400 mg QD
n=23 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 100 mg BID
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 100 mg BID for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 200 mg BID
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 200 mg BID for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 400 mg QD
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to Week 52 and Week 104 in Ellipsoid Zone (EZ) - (RPE) Macular Volume in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT
Study Eye: Change at Week 52
|
-0.09 cubic millimeters (mm^3)
Standard Deviation 0.074
|
-0.07 cubic millimeters (mm^3)
Standard Deviation 0.047
|
-0.09 cubic millimeters (mm^3)
Standard Deviation 0.048
|
-0.06 cubic millimeters (mm^3)
Standard Deviation 0.063
|
-0.05 cubic millimeters (mm^3)
Standard Deviation 0.063
|
-0.06 cubic millimeters (mm^3)
Standard Deviation 0.058
|
-0.08 cubic millimeters (mm^3)
Standard Deviation 0.069
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Ellipsoid Zone (EZ) - (RPE) Macular Volume in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT
Study Eye: Change at Week 104
|
-0.18 cubic millimeters (mm^3)
Standard Deviation 0.066
|
-0.10 cubic millimeters (mm^3)
Standard Deviation 0.098
|
-0.16 cubic millimeters (mm^3)
Standard Deviation 0.089
|
—
|
-0.10 cubic millimeters (mm^3)
Standard Deviation 0.064
|
-0.13 cubic millimeters (mm^3)
Standard Deviation 0.107
|
-0.12 cubic millimeters (mm^3)
Standard Deviation 0.068
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Ellipsoid Zone (EZ) - (RPE) Macular Volume in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT
Fellow Eye: Change at Week 52
|
-0.08 cubic millimeters (mm^3)
Standard Deviation 0.062
|
-0.05 cubic millimeters (mm^3)
Standard Deviation 0.047
|
-0.08 cubic millimeters (mm^3)
Standard Deviation 0.059
|
-0.07 cubic millimeters (mm^3)
Standard Deviation 0.052
|
-0.06 cubic millimeters (mm^3)
Standard Deviation 0.052
|
-0.08 cubic millimeters (mm^3)
Standard Deviation 0.052
|
-0.08 cubic millimeters (mm^3)
Standard Deviation 0.053
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Ellipsoid Zone (EZ) - (RPE) Macular Volume in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT
Fellow Eye: Change at Week 104
|
-0.16 cubic millimeters (mm^3)
Standard Deviation 0.097
|
-0.11 cubic millimeters (mm^3)
Standard Deviation 0.056
|
-0.16 cubic millimeters (mm^3)
Standard Deviation 0.122
|
—
|
-0.10 cubic millimeters (mm^3)
Standard Deviation 0.082
|
-0.13 cubic millimeters (mm^3)
Standard Deviation 0.075
|
-0.16 cubic millimeters (mm^3)
Standard Deviation 0.037
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Ellipsoid Zone (EZ) - (RPE) Macular Volume in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT
Both Eyes Combined: Change at Week 52
|
-0.15 cubic millimeters (mm^3)
Standard Deviation 0.115
|
-0.10 cubic millimeters (mm^3)
Standard Deviation 0.069
|
-0.16 cubic millimeters (mm^3)
Standard Deviation 0.089
|
-0.13 cubic millimeters (mm^3)
Standard Deviation 0.098
|
-0.11 cubic millimeters (mm^3)
Standard Deviation 0.103
|
-0.12 cubic millimeters (mm^3)
Standard Deviation 0.082
|
-0.15 cubic millimeters (mm^3)
Standard Deviation 0.106
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Ellipsoid Zone (EZ) - (RPE) Macular Volume in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT
Both Eyes Combined: Change at Week 104
|
-0.29 cubic millimeters (mm^3)
Standard Deviation 0.170
|
-0.17 cubic millimeters (mm^3)
Standard Deviation 0.143
|
-0.32 cubic millimeters (mm^3)
Standard Deviation 0.174
|
—
|
-0.18 cubic millimeters (mm^3)
Standard Deviation 0.135
|
-0.23 cubic millimeters (mm^3)
Standard Deviation 0.133
|
-0.28 cubic millimeters (mm^3)
Standard Deviation 0.069
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 52 and Week 104Population: All participants in FAS (all randomized participants who received at least 1 dose \[full or partial\] of study drug grouped by randomized treatment) with both baseline and post-baseline (Week 52 and Week 104) visit EZ-RPE mean central 1 mm subfield thickness data. As prespecified, data were collected and reported for participants. Therefore, 'Ns' reported below= number of participants analyzed regardless of which eye was evaluated. Number analyzed = participants evaluable for specified categories.
The EZ - RPE mean central 1 mm subfield thickness is a measurement of the thickness of the ellipsoid zone, a layer within the retina, in the central 1 mm region. Changes in EZ-RPE thickness indicate damage or dysfunction within the photoreceptors, which is associated with various eye diseases like AMD.
Outcome measures
| Measure |
Danicopan 100 mg BID
n=72 Participants
Participants received danicopan 100 mg BID during the 104-week Masked Treatment Period.
|
Danicopan 200 mg BID
n=65 Participants
Participants received danicopan 200 mg BID during the 104-week Masked Treatment Period.
|
Danicopan 400 mg QD
n=72 Participants
Participants received danicopan 400 mg QD during the 104-week Masked Treatment Period.
|
Placebo
n=70 Participants
Participants received matching placebo and were re-randomized to one of the active treatment groups at Week 52.
|
Placebo - Danicopan 200 mg BID
n=24 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 200 mg BID for the remainder of the study.
|
Placebo - Danicopan 400 mg QD
n=23 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
Placebo - Danicopan 400 mg QD
n=23 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 100 mg BID
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 100 mg BID for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 200 mg BID
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 200 mg BID for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 400 mg QD
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to Week 52 and Week 104 in EZ-RPE Mean Central 1 mm Subfield Thickness in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT
Study Eye: Change at Week 52
|
-4.03 µm
Standard Deviation 3.888
|
-3.48 µm
Standard Deviation 4.243
|
-3.83 µm
Standard Deviation 4.044
|
-3.16 µm
Standard Deviation 4.466
|
-2.40 µm
Standard Deviation 2.863
|
-3.85 µm
Standard Deviation 6.048
|
-3.25 µm
Standard Deviation 3.944
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in EZ-RPE Mean Central 1 mm Subfield Thickness in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT
Study Eye: Change at Week 104
|
-8.32 µm
Standard Deviation 4.050
|
-5.70 µm
Standard Deviation 5.327
|
-6.47 µm
Standard Deviation 5.111
|
—
|
-5.82 µm
Standard Deviation 4.866
|
-6.76 µm
Standard Deviation 6.100
|
-2.76 µm
Standard Deviation 2.737
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in EZ-RPE Mean Central 1 mm Subfield Thickness in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT
Fellow Eye: Change at Week 52
|
-2.51 µm
Standard Deviation 4.076
|
-1.93 µm
Standard Deviation 3.043
|
-3.01 µm
Standard Deviation 3.685
|
-3.52 µm
Standard Deviation 4.738
|
-3.51 µm
Standard Deviation 4.338
|
-3.42 µm
Standard Deviation 4.103
|
-3.61 µm
Standard Deviation 5.753
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in EZ-RPE Mean Central 1 mm Subfield Thickness in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT
Fellow Eye: Change at Week 104
|
-5.23 µm
Standard Deviation 4.879
|
-4.26 µm
Standard Deviation 3.160
|
-5.05 µm
Standard Deviation 4.629
|
—
|
-4.10 µm
Standard Deviation 7.591
|
-3.15 µm
Standard Deviation 3.755
|
-4.30 µm
Standard Deviation 5.902
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in EZ-RPE Mean Central 1 mm Subfield Thickness in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT
Both Eyes Combined: Change at Week 52
|
-6.03 µm
Standard Deviation 6.163
|
-4.85 µm
Standard Deviation 5.035
|
-6.55 µm
Standard Deviation 5.942
|
-6.09 µm
Standard Deviation 6.692
|
-5.37 µm
Standard Deviation 5.864
|
-6.53 µm
Standard Deviation 7.175
|
-6.40 µm
Standard Deviation 7.224
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in EZ-RPE Mean Central 1 mm Subfield Thickness in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT
Both Eyes Combined: Change at Week 104
|
-11.41 µm
Standard Deviation 8.175
|
-8.46 µm
Standard Deviation 5.799
|
-11.18 µm
Standard Deviation 7.506
|
—
|
-9.23 µm
Standard Deviation 9.970
|
-9.28 µm
Standard Deviation 7.248
|
-7.06 µm
Standard Deviation 7.138
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 52 and Week 104Population: All participants in FAS (all randomized participants who received at least 1 dose \[full or partial\] of study drug grouped by randomized treatment) with both baseline and post-baseline (Week 52 and Week 104) visit EZ-RPE mean central macular 2 mm thickness data. As prespecified, data were collected and reported for participants. Therefore, 'Ns' reported below= number of participants analyzed regardless of which eye was evaluated. Number analyzed = participants evaluable for specified categories.
The EZ - RPE mean central macular 2 mm thickness measurement reflects the distance between the outer border of the EZ and the inner border of the RPE layer, typically within a central 2 mm area. Decreased EZ-RPE thickness is an early indicator of disease, such as in dry AMD, where a thinning or loss of the EZ is a hallmark. Changes in EZ-RPE thickness is used to monitor treatment response in conditions like AMD.
Outcome measures
| Measure |
Danicopan 100 mg BID
n=72 Participants
Participants received danicopan 100 mg BID during the 104-week Masked Treatment Period.
|
Danicopan 200 mg BID
n=65 Participants
Participants received danicopan 200 mg BID during the 104-week Masked Treatment Period.
|
Danicopan 400 mg QD
n=72 Participants
Participants received danicopan 400 mg QD during the 104-week Masked Treatment Period.
|
Placebo
n=70 Participants
Participants received matching placebo and were re-randomized to one of the active treatment groups at Week 52.
|
Placebo - Danicopan 200 mg BID
n=24 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 200 mg BID for the remainder of the study.
|
Placebo - Danicopan 400 mg QD
n=23 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
Placebo - Danicopan 400 mg QD
n=23 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 100 mg BID
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 100 mg BID for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 200 mg BID
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 200 mg BID for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 400 mg QD
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to Week 52 and Week 104 in EZ-RPE Mean Central Macular 2 mm Thickness in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT
Study Eye: Change at Week 52
|
-3.45 µm
Standard Deviation 2.971
|
-2.75 µm
Standard Deviation 2.633
|
-3.20 µm
Standard Deviation 2.622
|
-2.58 µm
Standard Deviation 2.819
|
-2.58 µm
Standard Deviation 3.012
|
-2.70 µm
Standard Deviation 3.011
|
-2.45 µm
Standard Deviation 2.512
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in EZ-RPE Mean Central Macular 2 mm Thickness in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT
Study Eye: Change at Week 104
|
-7.44 µm
Standard Deviation 3.218
|
-5.21 µm
Standard Deviation 4.657
|
-5.46 µm
Standard Deviation 3.400
|
—
|
-5.05 µm
Standard Deviation 4.337
|
-5.56 µm
Standard Deviation 3.808
|
-3.00 µm
Standard Deviation 1.925
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in EZ-RPE Mean Central Macular 2 mm Thickness in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT
Fellow Eye: Change at Week 52
|
-2.51 µm
Standard Deviation 3.042
|
-1.93 µm
Standard Deviation 3.082
|
-2.76 µm
Standard Deviation 3.147
|
-3.22 µm
Standard Deviation 3.844
|
-3.50 µm
Standard Deviation 3.502
|
-2.97 µm
Standard Deviation 3.983
|
-3.16 µm
Standard Deviation 4.206
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in EZ-RPE Mean Central Macular 2 mm Thickness in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT
Fellow Eye: Change at Week 104
|
-5.58 µm
Standard Deviation 5.229
|
-3.38 µm
Standard Deviation 2.564
|
-4.89 µm
Standard Deviation 5.228
|
—
|
-3.50 µm
Standard Deviation 6.461
|
-4.05 µm
Standard Deviation 5.544
|
-3.80 µm
Standard Deviation 4.506
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in EZ-RPE Mean Central Macular 2 mm Thickness in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT
Both Eyes Combined: Change at Week 52
|
-5.46 µm
Standard Deviation 4.343
|
-4.11 µm
Standard Deviation 3.792
|
-5.68 µm
Standard Deviation 4.637
|
-5.27 µm
Standard Deviation 5.408
|
-5.54 µm
Standard Deviation 5.618
|
-5.03 µm
Standard Deviation 5.235
|
-5.23 µm
Standard Deviation 5.584
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in EZ-RPE Mean Central Macular 2 mm Thickness in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT
Both Eyes Combined: Change at Week 104
|
-10.96 µm
Standard Deviation 7.034
|
-7.40 µm
Standard Deviation 5.216
|
-10.06 µm
Standard Deviation 7.266
|
—
|
-7.97 µm
Standard Deviation 8.308
|
-8.80 µm
Standard Deviation 7.525
|
-6.80 µm
Standard Deviation 5.094
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 52 and Week 104Population: All participants in the FAS (all randomized participants who received at least 1 dose \[full or partial\] of study drug grouped by randomized treatment group) with both baseline and post-baseline (Week 52 and Week 104) visit SD-OCT data. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated. Number analyzed = participants evaluable for specified categories.
The percentage of total attenuation of the EZ in the central 1 mm subfield is reported.
Outcome measures
| Measure |
Danicopan 100 mg BID
n=72 Participants
Participants received danicopan 100 mg BID during the 104-week Masked Treatment Period.
|
Danicopan 200 mg BID
n=65 Participants
Participants received danicopan 200 mg BID during the 104-week Masked Treatment Period.
|
Danicopan 400 mg QD
n=72 Participants
Participants received danicopan 400 mg QD during the 104-week Masked Treatment Period.
|
Placebo
n=70 Participants
Participants received matching placebo and were re-randomized to one of the active treatment groups at Week 52.
|
Placebo - Danicopan 200 mg BID
n=24 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 200 mg BID for the remainder of the study.
|
Placebo - Danicopan 400 mg QD
n=23 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
Placebo - Danicopan 400 mg QD
n=23 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 100 mg BID
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 100 mg BID for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 200 mg BID
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 200 mg BID for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 400 mg QD
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to Week 52 and Week 104 in Percent Central 1 mm Subfield EZ Total Attenuation in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT
Study Eye: Change at Week 52
|
16.73 percentage of EZ total attenuation
Standard Deviation 16.914
|
15.93 percentage of EZ total attenuation
Standard Deviation 21.716
|
18.68 percentage of EZ total attenuation
Standard Deviation 20.417
|
13.69 percentage of EZ total attenuation
Standard Deviation 16.939
|
11.07 percentage of EZ total attenuation
Standard Deviation 13.674
|
12.68 percentage of EZ total attenuation
Standard Deviation 18.176
|
17.48 percentage of EZ total attenuation
Standard Deviation 18.703
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Percent Central 1 mm Subfield EZ Total Attenuation in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT
Study Eye: Change at Week 104
|
22.31 percentage of EZ total attenuation
Standard Deviation 17.890
|
20.14 percentage of EZ total attenuation
Standard Deviation 19.616
|
39.81 percentage of EZ total attenuation
Standard Deviation 26.391
|
—
|
19.40 percentage of EZ total attenuation
Standard Deviation 19.132
|
18.21 percentage of EZ total attenuation
Standard Deviation 23.796
|
19.61 percentage of EZ total attenuation
Standard Deviation 16.593
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Percent Central 1 mm Subfield EZ Total Attenuation in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT
Fellow Eye: Change at Week 52
|
9.16 percentage of EZ total attenuation
Standard Deviation 12.800
|
8.33 percentage of EZ total attenuation
Standard Deviation 16.198
|
12.68 percentage of EZ total attenuation
Standard Deviation 16.131
|
13.44 percentage of EZ total attenuation
Standard Deviation 17.791
|
13.33 percentage of EZ total attenuation
Standard Deviation 23.449
|
12.33 percentage of EZ total attenuation
Standard Deviation 10.834
|
14.51 percentage of EZ total attenuation
Standard Deviation 16.785
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Percent Central 1 mm Subfield EZ Total Attenuation in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT
Fellow Eye: Change at Week 104
|
20.59 percentage of EZ total attenuation
Standard Deviation 15.693
|
13.59 percentage of EZ total attenuation
Standard Deviation 16.375
|
24.22 percentage of EZ total attenuation
Standard Deviation 22.988
|
—
|
10.43 percentage of EZ total attenuation
Standard Deviation 12.638
|
13.11 percentage of EZ total attenuation
Standard Deviation 12.384
|
18.81 percentage of EZ total attenuation
Standard Deviation 17.001
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Percent Central 1 mm Subfield EZ Total Attenuation in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT
Both Eyes Combined: Change at Week 52
|
23.92 percentage of EZ total attenuation
Standard Deviation 21.961
|
21.82 percentage of EZ total attenuation
Standard Deviation 27.888
|
30.13 percentage of EZ total attenuation
Standard Deviation 26.472
|
24.82 percentage of EZ total attenuation
Standard Deviation 24.477
|
22.27 percentage of EZ total attenuation
Standard Deviation 27.116
|
22.33 percentage of EZ total attenuation
Standard Deviation 20.562
|
29.97 percentage of EZ total attenuation
Standard Deviation 25.421
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Percent Central 1 mm Subfield EZ Total Attenuation in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT
Both Eyes Combined: Change at Week 104
|
36.13 percentage of EZ total attenuation
Standard Deviation 29.699
|
28.93 percentage of EZ total attenuation
Standard Deviation 27.084
|
61.94 percentage of EZ total attenuation
Standard Deviation 38.776
|
—
|
28.09 percentage of EZ total attenuation
Standard Deviation 27.090
|
28.70 percentage of EZ total attenuation
Standard Deviation 31.841
|
38.42 percentage of EZ total attenuation
Standard Deviation 27.959
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 52 and Week 104Population: All participants in the FAS (all randomized participants who received at least 1 dose \[full or partial\] of study drug grouped by randomized treatment group) with both baseline and post-baseline (Week 52 and Week 104) visit SD-OCT data. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated. Number analyzed = participants evaluable for specified categories.
The percentage of partial attenuation of the EZ in the central 1 mm subfield is reported.
Outcome measures
| Measure |
Danicopan 100 mg BID
n=72 Participants
Participants received danicopan 100 mg BID during the 104-week Masked Treatment Period.
|
Danicopan 200 mg BID
n=65 Participants
Participants received danicopan 200 mg BID during the 104-week Masked Treatment Period.
|
Danicopan 400 mg QD
n=72 Participants
Participants received danicopan 400 mg QD during the 104-week Masked Treatment Period.
|
Placebo
n=70 Participants
Participants received matching placebo and were re-randomized to one of the active treatment groups at Week 52.
|
Placebo - Danicopan 200 mg BID
n=24 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 200 mg BID for the remainder of the study.
|
Placebo - Danicopan 400 mg QD
n=23 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
Placebo - Danicopan 400 mg QD
n=23 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 100 mg BID
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 100 mg BID for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 200 mg BID
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 200 mg BID for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 400 mg QD
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to Week 52 and Week 104 in Percent Central 1 mm Subfield EZ Partial Attenuation in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT
Study Eye: Change at Week 52
|
10.31 percentage of EZ partial attenuation
Standard Deviation 13.668
|
8.24 percentage of EZ partial attenuation
Standard Deviation 12.342
|
9.51 percentage of EZ partial attenuation
Standard Deviation 14.020
|
8.67 percentage of EZ partial attenuation
Standard Deviation 13.691
|
6.65 percentage of EZ partial attenuation
Standard Deviation 7.932
|
11.42 percentage of EZ partial attenuation
Standard Deviation 18.493
|
7.92 percentage of EZ partial attenuation
Standard Deviation 12.672
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Percent Central 1 mm Subfield EZ Partial Attenuation in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT
Study Eye: Change at Week 104
|
24.56 percentage of EZ partial attenuation
Standard Deviation 14.964
|
16.86 percentage of EZ partial attenuation
Standard Deviation 18.793
|
12.57 percentage of EZ partial attenuation
Standard Deviation 16.778
|
—
|
17.58 percentage of EZ partial attenuation
Standard Deviation 20.152
|
22.86 percentage of EZ partial attenuation
Standard Deviation 18.298
|
4.08 percentage of EZ partial attenuation
Standard Deviation 5.899
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Percent Central 1 mm Subfield EZ Partial Attenuation in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT
Fellow Eye: Change at Week 52
|
6.80 percentage of EZ partial attenuation
Standard Deviation 14.277
|
5.39 percentage of EZ partial attenuation
Standard Deviation 9.926
|
7.26 percentage of EZ partial attenuation
Standard Deviation 12.982
|
9.92 percentage of EZ partial attenuation
Standard Deviation 16.529
|
9.62 percentage of EZ partial attenuation
Standard Deviation 12.575
|
9.45 percentage of EZ partial attenuation
Standard Deviation 13.614
|
10.61 percentage of EZ partial attenuation
Standard Deviation 22.125
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Percent Central 1 mm Subfield EZ Partial Attenuation in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT
Fellow Eye: Change at Week 104
|
13.35 percentage of EZ partial attenuation
Standard Deviation 18.080
|
9.25 percentage of EZ partial attenuation
Standard Deviation 10.751
|
12.65 percentage of EZ partial attenuation
Standard Deviation 15.581
|
—
|
14.87 percentage of EZ partial attenuation
Standard Deviation 29.975
|
5.76 percentage of EZ partial attenuation
Standard Deviation 11.374
|
10.38 percentage of EZ partial attenuation
Standard Deviation 18.139
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Percent Central 1 mm Subfield EZ Partial Attenuation in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT
Both Eyes Combined: Change at Week 52
|
15.74 percentage of EZ partial attenuation
Standard Deviation 20.909
|
12.06 percentage of EZ partial attenuation
Standard Deviation 15.349
|
16.06 percentage of EZ partial attenuation
Standard Deviation 20.365
|
16.93 percentage of EZ partial attenuation
Standard Deviation 21.887
|
14.79 percentage of EZ partial attenuation
Standard Deviation 17.280
|
18.81 percentage of EZ partial attenuation
Standard Deviation 23.297
|
17.27 percentage of EZ partial attenuation
Standard Deviation 25.273
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Percent Central 1 mm Subfield EZ Partial Attenuation in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT
Both Eyes Combined: Change at Week 104
|
31.92 percentage of EZ partial attenuation
Standard Deviation 29.615
|
22.85 percentage of EZ partial attenuation
Standard Deviation 20.419
|
24.56 percentage of EZ partial attenuation
Standard Deviation 23.689
|
—
|
29.97 percentage of EZ partial attenuation
Standard Deviation 39.643
|
27.47 percentage of EZ partial attenuation
Standard Deviation 22.597
|
14.46 percentage of EZ partial attenuation
Standard Deviation 17.962
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 52 and Week 104Population: All participants in the FAS (all randomized participants who received at least 1 dose \[full or partial\] of study drug grouped by randomized treatment group) with both baseline and post-baseline (Week 52 and Week 104) visit SD-OCT data. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated. Number analyzed = participants evaluable for specified categories.
The percentage of total attenuation of the EZ in the central macular 2 mm subfield is reported.
Outcome measures
| Measure |
Danicopan 100 mg BID
n=72 Participants
Participants received danicopan 100 mg BID during the 104-week Masked Treatment Period.
|
Danicopan 200 mg BID
n=65 Participants
Participants received danicopan 200 mg BID during the 104-week Masked Treatment Period.
|
Danicopan 400 mg QD
n=72 Participants
Participants received danicopan 400 mg QD during the 104-week Masked Treatment Period.
|
Placebo
n=70 Participants
Participants received matching placebo and were re-randomized to one of the active treatment groups at Week 52.
|
Placebo - Danicopan 200 mg BID
n=24 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 200 mg BID for the remainder of the study.
|
Placebo - Danicopan 400 mg QD
n=23 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
Placebo - Danicopan 400 mg QD
n=23 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 100 mg BID
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 100 mg BID for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 200 mg BID
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 200 mg BID for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 400 mg QD
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to Week 52 and Week 104 in Percent Central Macular 2 mm Subfield EZ Total Attenuation in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT
Study Eye: Change at Week 52
|
16.04 percentage of EZ total attenuation
Standard Deviation 12.199
|
13.61 percentage of EZ total attenuation
Standard Deviation 13.797
|
16.10 percentage of EZ total attenuation
Standard Deviation 12.422
|
12.89 percentage of EZ total attenuation
Standard Deviation 11.554
|
12.66 percentage of EZ total attenuation
Standard Deviation 11.515
|
11.15 percentage of EZ total attenuation
Standard Deviation 8.184
|
14.96 percentage of EZ total attenuation
Standard Deviation 14.456
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Percent Central Macular 2 mm Subfield EZ Total Attenuation in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT
Study Eye: Change at Week 104
|
27.98 percentage of EZ total attenuation
Standard Deviation 14.597
|
23.25 percentage of EZ total attenuation
Standard Deviation 15.725
|
32.56 percentage of EZ total attenuation
Standard Deviation 15.265
|
—
|
21.46 percentage of EZ total attenuation
Standard Deviation 20.555
|
17.50 percentage of EZ total attenuation
Standard Deviation 6.271
|
19.63 percentage of EZ total attenuation
Standard Deviation 7.982
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Percent Central Macular 2 mm Subfield EZ Total Attenuation in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT
Fellow Eye: Change at Week 52
|
9.80 percentage of EZ total attenuation
Standard Deviation 11.161
|
8.84 percentage of EZ total attenuation
Standard Deviation 11.049
|
11.54 percentage of EZ total attenuation
Standard Deviation 11.821
|
13.21 percentage of EZ total attenuation
Standard Deviation 12.847
|
15.14 percentage of EZ total attenuation
Standard Deviation 14.786
|
11.79 percentage of EZ total attenuation
Standard Deviation 10.311
|
12.48 percentage of EZ total attenuation
Standard Deviation 13.098
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Percent Central Macular 2 mm Subfield EZ Total Attenuation in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT
Fellow Eye: Change at Week 104
|
21.45 percentage of EZ total attenuation
Standard Deviation 21.023
|
12.76 percentage of EZ total attenuation
Standard Deviation 9.657
|
22.72 percentage of EZ total attenuation
Standard Deviation 20.095
|
—
|
11.59 percentage of EZ total attenuation
Standard Deviation 13.028
|
18.41 percentage of EZ total attenuation
Standard Deviation 13.948
|
16.20 percentage of EZ total attenuation
Standard Deviation 13.464
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Percent Central Macular 2 mm Subfield EZ Total Attenuation in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT
Both Eyes Combined: Change at Week 52
|
23.81 percentage of EZ total attenuation
Standard Deviation 17.076
|
19.87 percentage of EZ total attenuation
Standard Deviation 18.112
|
26.52 percentage of EZ total attenuation
Standard Deviation 18.341
|
23.84 percentage of EZ total attenuation
Standard Deviation 19.218
|
25.38 percentage of EZ total attenuation
Standard Deviation 19.781
|
20.37 percentage of EZ total attenuation
Standard Deviation 14.102
|
25.71 percentage of EZ total attenuation
Standard Deviation 23.057
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Percent Central Macular 2 mm Subfield EZ Total Attenuation in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT
Both Eyes Combined: Change at Week 104
|
41.63 percentage of EZ total attenuation
Standard Deviation 25.286
|
31.50 percentage of EZ total attenuation
Standard Deviation 18.865
|
53.57 percentage of EZ total attenuation
Standard Deviation 30.657
|
—
|
31.12 percentage of EZ total attenuation
Standard Deviation 24.754
|
32.22 percentage of EZ total attenuation
Standard Deviation 18.972
|
35.83 percentage of EZ total attenuation
Standard Deviation 17.546
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 52 and Week 104Population: All participants in the FAS (all randomized participants who received at least 1 dose \[full or partial\] of study drug grouped by randomized treatment group) with both baseline and post-baseline (Week 52 and Week 104) visit SD-OCT data. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated. Number analyzed = participants evaluable for specified categories.
The percentage of partial attenuation of the EZ in the central macular 2 mm subfield is reported.
Outcome measures
| Measure |
Danicopan 100 mg BID
n=72 Participants
Participants received danicopan 100 mg BID during the 104-week Masked Treatment Period.
|
Danicopan 200 mg BID
n=65 Participants
Participants received danicopan 200 mg BID during the 104-week Masked Treatment Period.
|
Danicopan 400 mg QD
n=72 Participants
Participants received danicopan 400 mg QD during the 104-week Masked Treatment Period.
|
Placebo
n=70 Participants
Participants received matching placebo and were re-randomized to one of the active treatment groups at Week 52.
|
Placebo - Danicopan 200 mg BID
n=24 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 200 mg BID for the remainder of the study.
|
Placebo - Danicopan 400 mg QD
n=23 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
Placebo - Danicopan 400 mg QD
n=23 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 100 mg BID
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 100 mg BID for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 200 mg BID
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 200 mg BID for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 400 mg QD
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to Week 52 and Week 104 in Percent Central Macular 2 mm Subfield EZ Partial Attenuation in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT
Study Eye: Change at Week 52
|
8.24 percentage of EZ partial attenuation
Standard Deviation 10.598
|
6.09 percentage of EZ partial attenuation
Standard Deviation 7.169
|
7.54 percentage of EZ partial attenuation
Standard Deviation 8.630
|
6.37 percentage of EZ partial attenuation
Standard Deviation 8.079
|
6.67 percentage of EZ partial attenuation
Standard Deviation 7.237
|
6.93 percentage of EZ partial attenuation
Standard Deviation 9.374
|
5.46 percentage of EZ partial attenuation
Standard Deviation 7.746
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Percent Central Macular 2 mm Subfield EZ Partial Attenuation in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT
Study Eye: Change at Week 104
|
18.70 percentage of EZ partial attenuation
Standard Deviation 12.603
|
12.71 percentage of EZ partial attenuation
Standard Deviation 13.460
|
10.96 percentage of EZ partial attenuation
Standard Deviation 11.518
|
—
|
12.12 percentage of EZ partial attenuation
Standard Deviation 11.782
|
17.09 percentage of EZ partial attenuation
Standard Deviation 13.793
|
5.12 percentage of EZ partial attenuation
Standard Deviation 5.509
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Percent Central Macular 2 mm Subfield EZ Partial Attenuation in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT
Fellow Eye: Change at Week 52
|
6.24 percentage of EZ partial attenuation
Standard Deviation 9.738
|
5.12 percentage of EZ partial attenuation
Standard Deviation 9.238
|
6.73 percentage of EZ partial attenuation
Standard Deviation 11.225
|
9.07 percentage of EZ partial attenuation
Standard Deviation 12.589
|
9.62 percentage of EZ partial attenuation
Standard Deviation 10.501
|
8.30 percentage of EZ partial attenuation
Standard Deviation 12.676
|
9.17 percentage of EZ partial attenuation
Standard Deviation 14.826
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Percent Central Macular 2 mm Subfield EZ Partial Attenuation in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT
Fellow Eye: Change at Week 104
|
13.98 percentage of EZ partial attenuation
Standard Deviation 14.829
|
7.71 percentage of EZ partial attenuation
Standard Deviation 7.689
|
12.49 percentage of EZ partial attenuation
Standard Deviation 18.409
|
—
|
12.14 percentage of EZ partial attenuation
Standard Deviation 25.712
|
9.47 percentage of EZ partial attenuation
Standard Deviation 17.096
|
9.30 percentage of EZ partial attenuation
Standard Deviation 13.802
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Percent Central Macular 2 mm Subfield EZ Partial Attenuation in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT
Both Eyes Combined: Change at Week 52
|
13.27 percentage of EZ partial attenuation
Standard Deviation 14.756
|
9.71 percentage of EZ partial attenuation
Standard Deviation 10.869
|
13.61 percentage of EZ partial attenuation
Standard Deviation 15.682
|
13.96 percentage of EZ partial attenuation
Standard Deviation 16.418
|
14.82 percentage of EZ partial attenuation
Standard Deviation 15.686
|
13.42 percentage of EZ partial attenuation
Standard Deviation 16.367
|
13.59 percentage of EZ partial attenuation
Standard Deviation 17.862
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Percent Central Macular 2 mm Subfield EZ Partial Attenuation in the Study Eye, the Fellow Eye, and Both Eyes Combined as Measured by SD-OCT
Both Eyes Combined: Change at Week 104
|
27.52 percentage of EZ partial attenuation
Standard Deviation 23.015
|
17.70 percentage of EZ partial attenuation
Standard Deviation 15.710
|
22.87 percentage of EZ partial attenuation
Standard Deviation 24.193
|
—
|
22.24 percentage of EZ partial attenuation
Standard Deviation 31.056
|
24.67 percentage of EZ partial attenuation
Standard Deviation 24.320
|
14.41 percentage of EZ partial attenuation
Standard Deviation 14.806
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 52 and Week 104Population: All participants in FAS (all randomized participants who received at least 1 dose \[full or partial\] of study drug grouped by randomized treatment) with both baseline and post-baseline (Week 52 and Week 104) visit sub-RPE central 1 mm subfield mean thickness data. As prespecified, data were collected and reported for participants. Hence, 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated. Number analyzed = participants evaluable for specified categories.
Sub-RPE compartment measures reflect the disease burden between the RPE and Bruch's membrane. The sub-RPE central 1 mm mean thickness refers to the average thickness of the retina within a 1-mm diameter circular area centered around the fovea (the central part of the retina).
Outcome measures
| Measure |
Danicopan 100 mg BID
n=72 Participants
Participants received danicopan 100 mg BID during the 104-week Masked Treatment Period.
|
Danicopan 200 mg BID
n=65 Participants
Participants received danicopan 200 mg BID during the 104-week Masked Treatment Period.
|
Danicopan 400 mg QD
n=72 Participants
Participants received danicopan 400 mg QD during the 104-week Masked Treatment Period.
|
Placebo
n=70 Participants
Participants received matching placebo and were re-randomized to one of the active treatment groups at Week 52.
|
Placebo - Danicopan 200 mg BID
n=24 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 200 mg BID for the remainder of the study.
|
Placebo - Danicopan 400 mg QD
n=23 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
Placebo - Danicopan 400 mg QD
n=23 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 100 mg BID
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 100 mg BID for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 200 mg BID
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 200 mg BID for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 400 mg QD
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to Week 52 and Week 104 in Sub-RPE Central 1 mm Subfield Mean Thickness in the Study Eye, Fellow Eye and Both Eyes Combined as Measured by SD-OCT
Study Eye: Change at Week 52
|
-2.61 µm
Standard Deviation 5.838
|
-2.89 µm
Standard Deviation 4.863
|
-2.87 µm
Standard Deviation 5.842
|
-0.04 µm
Standard Deviation 12.832
|
-2.97 µm
Standard Deviation 5.403
|
-2.13 µm
Standard Deviation 6.814
|
5.19 µm
Standard Deviation 20.081
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Sub-RPE Central 1 mm Subfield Mean Thickness in the Study Eye, Fellow Eye and Both Eyes Combined as Measured by SD-OCT
Study Eye: Change at Week 104
|
-3.24 µm
Standard Deviation 11.423
|
-4.33 µm
Standard Deviation 7.450
|
-5.26 µm
Standard Deviation 9.398
|
—
|
-3.72 µm
Standard Deviation 7.208
|
-6.38 µm
Standard Deviation 9.288
|
-4.72 µm
Standard Deviation 9.648
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Sub-RPE Central 1 mm Subfield Mean Thickness in the Study Eye, Fellow Eye and Both Eyes Combined as Measured by SD-OCT
Fellow Eye: Change at Week 52
|
-0.84 µm
Standard Deviation 6.699
|
-1.50 µm
Standard Deviation 3.274
|
-2.42 µm
Standard Deviation 6.345
|
-2.33 µm
Standard Deviation 8.500
|
-1.13 µm
Standard Deviation 11.960
|
-0.59 µm
Standard Deviation 3.463
|
-5.00 µm
Standard Deviation 6.941
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Sub-RPE Central 1 mm Subfield Mean Thickness in the Study Eye, Fellow Eye and Both Eyes Combined as Measured by SD-OCT
Fellow Eye: Change at Week 104
|
-3.58 µm
Standard Deviation 9.171
|
-4.18 µm
Standard Deviation 6.176
|
-6.73 µm
Standard Deviation 9.984
|
—
|
-10.56 µm
Standard Deviation 11.610
|
-3.90 µm
Standard Deviation 5.368
|
-9.36 µm
Standard Deviation 12.776
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Sub-RPE Central 1 mm Subfield Mean Thickness in the Study Eye, Fellow Eye and Both Eyes Combined as Measured by SD-OCT
Both Eyes Combined: Change at Week 52
|
-3.23 µm
Standard Deviation 9.340
|
-3.95 µm
Standard Deviation 5.893
|
-5.05 µm
Standard Deviation 9.529
|
-2.04 µm
Standard Deviation 14.876
|
-3.83 µm
Standard Deviation 12.208
|
-2.60 µm
Standard Deviation 7.605
|
0.40 µm
Standard Deviation 21.689
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Sub-RPE Central 1 mm Subfield Mean Thickness in the Study Eye, Fellow Eye and Both Eyes Combined as Measured by SD-OCT
Both Eyes Combined: Change at Week 104
|
-5.74 µm
Standard Deviation 14.485
|
-7.04 µm
Standard Deviation 9.644
|
-11.72 µm
Standard Deviation 16.323
|
—
|
-12.52 µm
Standard Deviation 16.342
|
-9.50 µm
Standard Deviation 12.294
|
-14.08 µm
Standard Deviation 21.741
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 52 and Week 104Population: All participants in FAS (randomized participants who received at least 1 dose \[full/partial\] of study drug grouped by randomized treatment) with both baseline and post-baseline (Week 52 and Week 104) visit sub-RPE central macular 2 mm subfield mean thickness data. As prespecified, data were collected and reported for participants. Hence, 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated. Number analyzed = participants evaluable for specified categories.
Sub-RPE compartment measures reflect the disease burden between the RPE and Bruch's membrane. The sub-RPE central macular 2 mm subfield thickness refers to the thickness of the retina within a 2-mm radius in the central part of the macula.
Outcome measures
| Measure |
Danicopan 100 mg BID
n=72 Participants
Participants received danicopan 100 mg BID during the 104-week Masked Treatment Period.
|
Danicopan 200 mg BID
n=65 Participants
Participants received danicopan 200 mg BID during the 104-week Masked Treatment Period.
|
Danicopan 400 mg QD
n=72 Participants
Participants received danicopan 400 mg QD during the 104-week Masked Treatment Period.
|
Placebo
n=70 Participants
Participants received matching placebo and were re-randomized to one of the active treatment groups at Week 52.
|
Placebo - Danicopan 200 mg BID
n=24 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 200 mg BID for the remainder of the study.
|
Placebo - Danicopan 400 mg QD
n=23 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
Placebo - Danicopan 400 mg QD
n=23 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 100 mg BID
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 100 mg BID for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 200 mg BID
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 200 mg BID for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 400 mg QD
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to Week 52 and Week 104 in Sub-RPE Central Macular 2 mm Subfield Mean Thickness in the Study Eye, Fellow Eye and Both Eyes Combined as Measured by SD-OCT
Study Eye: Change at Week 52
|
-2.75 µm
Standard Deviation 4.229
|
-3.34 µm
Standard Deviation 3.314
|
-3.02 µm
Standard Deviation 4.064
|
-1.88 µm
Standard Deviation 5.550
|
-3.36 µm
Standard Deviation 4.148
|
-2.06 µm
Standard Deviation 3.834
|
-0.15 µm
Standard Deviation 7.701
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Sub-RPE Central Macular 2 mm Subfield Mean Thickness in the Study Eye, Fellow Eye and Both Eyes Combined as Measured by SD-OCT
Study Eye: Change at Week 104
|
-5.80 µm
Standard Deviation 9.514
|
-5.35 µm
Standard Deviation 4.290
|
-6.22 µm
Standard Deviation 3.954
|
—
|
-3.78 µm
Standard Deviation 7.190
|
-4.32 µm
Standard Deviation 2.743
|
-5.16 µm
Standard Deviation 4.527
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Sub-RPE Central Macular 2 mm Subfield Mean Thickness in the Study Eye, Fellow Eye and Both Eyes Combined as Measured by SD-OCT
Fellow Eye: Change at Week 52
|
-1.66 µm
Standard Deviation 4.750
|
-3.07 µm
Standard Deviation 3.575
|
-2.93 µm
Standard Deviation 3.552
|
-3.12 µm
Standard Deviation 5.733
|
-2.79 µm
Standard Deviation 7.131
|
-1.24 µm
Standard Deviation 3.434
|
-5.06 µm
Standard Deviation 5.370
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Sub-RPE Central Macular 2 mm Subfield Mean Thickness in the Study Eye, Fellow Eye and Both Eyes Combined as Measured by SD-OCT
Fellow Eye: Change at Week 104
|
-4.42 µm
Standard Deviation 9.773
|
-9.15 µm
Standard Deviation 13.049
|
-6.33 µm
Standard Deviation 5.931
|
—
|
-9.90 µm
Standard Deviation 10.970
|
-5.08 µm
Standard Deviation 2.898
|
-12.30 µm
Standard Deviation 10.238
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Sub-RPE Central Macular 2 mm Subfield Mean Thickness in the Study Eye, Fellow Eye and Both Eyes Combined as Measured by SD-OCT
Both Eyes Combined: Change at Week 52
|
-4.06 µm
Standard Deviation 6.749
|
-5.51 µm
Standard Deviation 5.298
|
-5.67 µm
Standard Deviation 5.790
|
-4.50 µm
Standard Deviation 7.649
|
-5.66 µm
Standard Deviation 7.552
|
-3.03 µm
Standard Deviation 4.963
|
-4.77 µm
Standard Deviation 9.770
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Sub-RPE Central Macular 2 mm Subfield Mean Thickness in the Study Eye, Fellow Eye and Both Eyes Combined as Measured by SD-OCT
Both Eyes Combined: Change at Week 104
|
-8.61 µm
Standard Deviation 12.280
|
-11.28 µm
Standard Deviation 12.963
|
-12.22 µm
Standard Deviation 8.602
|
—
|
-12.03 µm
Standard Deviation 16.671
|
-8.38 µm
Standard Deviation 5.509
|
-17.46 µm
Standard Deviation 11.297
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 52 and Week 104Population: All participants in FAS (all randomized participants who received at least 1 dose \[full or partial\] of study drug grouped by randomized treatment group) with both baseline and post-baseline (Week 52 and Week 104) visit panmacular sub-RPE volume data. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated. Number analyzed = participants evaluable for specified categories.
Sub-RPE compartment measures reflect the disease burden between the RPE and Bruch's membrane. The panmacular sub-RPE volume refers to the total volume of fluid or space located underneath the RPE across the entire macula (the central part of the retina).
Outcome measures
| Measure |
Danicopan 100 mg BID
n=72 Participants
Participants received danicopan 100 mg BID during the 104-week Masked Treatment Period.
|
Danicopan 200 mg BID
n=65 Participants
Participants received danicopan 200 mg BID during the 104-week Masked Treatment Period.
|
Danicopan 400 mg QD
n=72 Participants
Participants received danicopan 400 mg QD during the 104-week Masked Treatment Period.
|
Placebo
n=70 Participants
Participants received matching placebo and were re-randomized to one of the active treatment groups at Week 52.
|
Placebo - Danicopan 200 mg BID
n=24 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 200 mg BID for the remainder of the study.
|
Placebo - Danicopan 400 mg QD
n=23 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
Placebo - Danicopan 400 mg QD
n=23 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 100 mg BID
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 100 mg BID for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 200 mg BID
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 200 mg BID for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 400 mg QD
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to Week 52 and Week 104 in Panmacular Sub-RPE Volume in the Study Eye, Fellow Eye and Both Eyes Combined as Measured by SD-OCT
Study Eye: Change at Week 52
|
-0.04 mm^3
Standard Deviation 0.052
|
-0.04 mm^3
Standard Deviation 0.050
|
-0.05 mm^3
Standard Deviation 0.059
|
-0.04 mm^3
Standard Deviation 0.066
|
-0.06 mm^3
Standard Deviation 0.079
|
-0.03 mm^3
Standard Deviation 0.064
|
-0.03 mm^3
Standard Deviation 0.051
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Panmacular Sub-RPE Volume in the Study Eye, Fellow Eye and Both Eyes Combined as Measured by SD-OCT
Study Eye: Change at Week 104
|
-0.08 mm^3
Standard Deviation 0.076
|
-0.07 mm^3
Standard Deviation 0.085
|
-0.09 mm^3
Standard Deviation 0.065
|
—
|
-0.05 mm^3
Standard Deviation 0.094
|
-0.10 mm^3
Standard Deviation 0.063
|
-0.06 mm^3
Standard Deviation 0.091
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Panmacular Sub-RPE Volume in the Study Eye, Fellow Eye and Both Eyes Combined as Measured by SD-OCT
Fellow Eye: Change at Week 52
|
-0.04 mm^3
Standard Deviation 0.074
|
-0.04 mm^3
Standard Deviation 0.048
|
-0.04 mm^3
Standard Deviation 0.054
|
-0.04 mm^3
Standard Deviation 0.068
|
-0.05 mm^3
Standard Deviation 0.082
|
-0.02 mm^3
Standard Deviation 0.053
|
-0.06 mm^3
Standard Deviation 0.062
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Panmacular Sub-RPE Volume in the Study Eye, Fellow Eye and Both Eyes Combined as Measured by SD-OCT
Fellow Eye: Change at Week 104
|
-0.08 mm^3
Standard Deviation 0.084
|
-0.09 mm^3
Standard Deviation 0.098
|
-0.08 mm^3
Standard Deviation 0.085
|
—
|
-0.11 mm^3
Standard Deviation 0.114
|
-0.05 mm^3
Standard Deviation 0.050
|
-0.17 mm^3
Standard Deviation 0.123
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Panmacular Sub-RPE Volume in the Study Eye, Fellow Eye and Both Eyes Combined as Measured by SD-OCT
Both Eyes Combined: Change at Week 52
|
-0.07 mm^3
Standard Deviation 0.102
|
-0.06 mm^3
Standard Deviation 0.073
|
-0.08 mm^3
Standard Deviation 0.088
|
-0.08 mm^3
Standard Deviation 0.111
|
-0.09 mm^3
Standard Deviation 0.142
|
-0.05 mm^3
Standard Deviation 0.089
|
-0.08 mm^3
Standard Deviation 0.093
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Panmacular Sub-RPE Volume in the Study Eye, Fellow Eye and Both Eyes Combined as Measured by SD-OCT
Both Eyes Combined: Change at Week 104
|
-0.14 mm^3
Standard Deviation 0.127
|
-0.12 mm^3
Standard Deviation 0.160
|
-0.17 mm^3
Standard Deviation 0.128
|
—
|
-0.14 mm^3
Standard Deviation 0.196
|
-0.14 mm^3
Standard Deviation 0.085
|
-0.24 mm^3
Standard Deviation 0.074
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 52 and Week 104Population: All participants in FAS (all randomized participants who received at least 1 dose \[full or partial\] of study drug grouped by randomized treatment group) with both baseline and post-baseline (Week 52 and Week 104) visit macular total RPE attenuation data. As prespecified, data were collected and reported for participants. Therefore, 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated. Number analyzed = participants evaluable for specified categories.
Macular total RPE attenuation refers to the degree of thinning or loss of the RPE in the macula, the central part of the retina responsible for sharp, detailed vision. This was measured as a percentage of the macular area affected.
Outcome measures
| Measure |
Danicopan 100 mg BID
n=72 Participants
Participants received danicopan 100 mg BID during the 104-week Masked Treatment Period.
|
Danicopan 200 mg BID
n=65 Participants
Participants received danicopan 200 mg BID during the 104-week Masked Treatment Period.
|
Danicopan 400 mg QD
n=72 Participants
Participants received danicopan 400 mg QD during the 104-week Masked Treatment Period.
|
Placebo
n=70 Participants
Participants received matching placebo and were re-randomized to one of the active treatment groups at Week 52.
|
Placebo - Danicopan 200 mg BID
n=24 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 200 mg BID for the remainder of the study.
|
Placebo - Danicopan 400 mg QD
n=23 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
Placebo - Danicopan 400 mg QD
n=23 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 100 mg BID
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 100 mg BID for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 200 mg BID
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 200 mg BID for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 400 mg QD
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to Week 52 and Week 104 in Percent Macular Total RPE Attenuation in the Study Eye, Fellow Eye and Both Eyes Combined as Measured by SD-OCT
Both Eyes Combined: Change at Week 52
|
10.36 percentage of macular area
Standard Deviation 6.652
|
8.58 percentage of macular area
Standard Deviation 5.429
|
11.42 percentage of macular area
Standard Deviation 6.976
|
10.62 percentage of macular area
Standard Deviation 7.048
|
10.09 percentage of macular area
Standard Deviation 6.376
|
9.06 percentage of macular area
Standard Deviation 6.227
|
12.73 percentage of macular area
Standard Deviation 8.186
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Percent Macular Total RPE Attenuation in the Study Eye, Fellow Eye and Both Eyes Combined as Measured by SD-OCT
Study Eye: Change at Week 52
|
6.11 percentage of macular area
Standard Deviation 3.874
|
5.11 percentage of macular area
Standard Deviation 2.706
|
6.38 percentage of macular area
Standard Deviation 3.718
|
5.48 percentage of macular area
Standard Deviation 3.413
|
5.47 percentage of macular area
Standard Deviation 3.043
|
5.00 percentage of macular area
Standard Deviation 3.328
|
6.00 percentage of macular area
Standard Deviation 3.916
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Percent Macular Total RPE Attenuation in the Study Eye, Fellow Eye and Both Eyes Combined as Measured by SD-OCT
Study Eye: Change at Week 104
|
10.66 percentage of macular area
Standard Deviation 6.579
|
9.18 percentage of macular area
Standard Deviation 5.951
|
11.64 percentage of macular area
Standard Deviation 4.956
|
—
|
7.86 percentage of macular area
Standard Deviation 4.673
|
12.68 percentage of macular area
Standard Deviation 6.330
|
11.77 percentage of macular area
Standard Deviation 5.205
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Percent Macular Total RPE Attenuation in the Study Eye, Fellow Eye and Both Eyes Combined as Measured by SD-OCT
Fellow Eye: Change at Week 52
|
5.23 percentage of macular area
Standard Deviation 3.594
|
5.00 percentage of macular area
Standard Deviation 3.549
|
5.59 percentage of macular area
Standard Deviation 4.513
|
6.18 percentage of macular area
Standard Deviation 4.043
|
5.55 percentage of macular area
Standard Deviation 3.474
|
5.18 percentage of macular area
Standard Deviation 3.740
|
7.66 percentage of macular area
Standard Deviation 4.545
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Percent Macular Total RPE Attenuation in the Study Eye, Fellow Eye and Both Eyes Combined as Measured by SD-OCT
Fellow Eye: Change at Week 104
|
10.96 percentage of macular area
Standard Deviation 6.159
|
8.50 percentage of macular area
Standard Deviation 6.472
|
11.49 percentage of macular area
Standard Deviation 8.582
|
—
|
10.38 percentage of macular area
Standard Deviation 7.719
|
11.82 percentage of macular area
Standard Deviation 6.691
|
16.12 percentage of macular area
Standard Deviation 4.807
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Percent Macular Total RPE Attenuation in the Study Eye, Fellow Eye and Both Eyes Combined as Measured by SD-OCT
Both Eyes Combined: Change at Week 104
|
18.20 percentage of macular area
Standard Deviation 12.155
|
14.14 percentage of macular area
Standard Deviation 11.759
|
22.52 percentage of macular area
Standard Deviation 12.076
|
—
|
16.51 percentage of macular area
Standard Deviation 12.246
|
22.14 percentage of macular area
Standard Deviation 10.270
|
27.89 percentage of macular area
Standard Deviation 8.760
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 52 and Week 104Population: All participants in FAS (all randomized participants who received at least 1 dose \[full or partial\] of study drug grouped by randomized treatment) with both baseline and post-baseline (Week 52 and Week 104) visit central 1 mm subfield total RPE attenuation data. As prespecified, data were collected and reported for participants. Hence, 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated. Number analyzed = participants evaluable for specified categories.
The percentage of total attenuation of the RPE in the central 1 mm subfield is reported.
Outcome measures
| Measure |
Danicopan 100 mg BID
n=72 Participants
Participants received danicopan 100 mg BID during the 104-week Masked Treatment Period.
|
Danicopan 200 mg BID
n=65 Participants
Participants received danicopan 200 mg BID during the 104-week Masked Treatment Period.
|
Danicopan 400 mg QD
n=72 Participants
Participants received danicopan 400 mg QD during the 104-week Masked Treatment Period.
|
Placebo
n=70 Participants
Participants received matching placebo and were re-randomized to one of the active treatment groups at Week 52.
|
Placebo - Danicopan 200 mg BID
n=24 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 200 mg BID for the remainder of the study.
|
Placebo - Danicopan 400 mg QD
n=23 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
Placebo - Danicopan 400 mg QD
n=23 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 100 mg BID
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 100 mg BID for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 200 mg BID
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 200 mg BID for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 400 mg QD
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to Week 52 and Week 104 in Percent Central 1 mm Subfield Total RPE Attenuation in the Study Eye, Fellow Eye and Both Eyes Combined as Measured by SD-OCT
Study Eye: Change at Week 52
|
10.27 percentage of total RPE attenuation
Standard Deviation 13.204
|
8.60 percentage of total RPE attenuation
Standard Deviation 11.277
|
9.60 percentage of total RPE attenuation
Standard Deviation 13.794
|
8.16 percentage of total RPE attenuation
Standard Deviation 12.335
|
9.85 percentage of total RPE attenuation
Standard Deviation 13.381
|
9.02 percentage of total RPE attenuation
Standard Deviation 13.346
|
5.48 percentage of total RPE attenuation
Standard Deviation 9.989
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Percent Central 1 mm Subfield Total RPE Attenuation in the Study Eye, Fellow Eye and Both Eyes Combined as Measured by SD-OCT
Study Eye: Change at Week 104
|
15.56 percentage of total RPE attenuation
Standard Deviation 18.923
|
14.77 percentage of total RPE attenuation
Standard Deviation 12.017
|
19.42 percentage of total RPE attenuation
Standard Deviation 18.209
|
—
|
13.89 percentage of total RPE attenuation
Standard Deviation 12.330
|
28.62 percentage of total RPE attenuation
Standard Deviation 27.097
|
15.79 percentage of total RPE attenuation
Standard Deviation 29.801
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Percent Central 1 mm Subfield Total RPE Attenuation in the Study Eye, Fellow Eye and Both Eyes Combined as Measured by SD-OCT
Fellow Eye: Change at Week 52
|
7.48 percentage of total RPE attenuation
Standard Deviation 12.846
|
5.91 percentage of total RPE attenuation
Standard Deviation 10.333
|
8.67 percentage of total RPE attenuation
Standard Deviation 11.815
|
9.69 percentage of total RPE attenuation
Standard Deviation 15.031
|
7.33 percentage of total RPE attenuation
Standard Deviation 10.670
|
6.46 percentage of total RPE attenuation
Standard Deviation 7.800
|
14.81 percentage of total RPE attenuation
Standard Deviation 21.405
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Percent Central 1 mm Subfield Total RPE Attenuation in the Study Eye, Fellow Eye and Both Eyes Combined as Measured by SD-OCT
Fellow Eye: Change at Week 104
|
15.43 percentage of total RPE attenuation
Standard Deviation 13.245
|
9.84 percentage of total RPE attenuation
Standard Deviation 13.900
|
20.71 percentage of total RPE attenuation
Standard Deviation 18.542
|
—
|
21.88 percentage of total RPE attenuation
Standard Deviation 20.194
|
22.45 percentage of total RPE attenuation
Standard Deviation 22.899
|
23.19 percentage of total RPE attenuation
Standard Deviation 37.563
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Percent Central 1 mm Subfield Total RPE Attenuation in the Study Eye, Fellow Eye and Both Eyes Combined as Measured by SD-OCT
Both Eyes Combined: Change at Week 52
|
16.29 percentage of total RPE attenuation
Standard Deviation 21.116
|
12.79 percentage of total RPE attenuation
Standard Deviation 16.127
|
17.43 percentage of total RPE attenuation
Standard Deviation 19.549
|
16.23 percentage of total RPE attenuation
Standard Deviation 21.394
|
15.85 percentage of total RPE attenuation
Standard Deviation 19.996
|
14.08 percentage of total RPE attenuation
Standard Deviation 18.363
|
18.76 percentage of total RPE attenuation
Standard Deviation 25.857
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Percent Central 1 mm Subfield Total RPE Attenuation in the Study Eye, Fellow Eye and Both Eyes Combined as Measured by SD-OCT
Both Eyes Combined: Change at Week 104
|
26.10 percentage of total RPE attenuation
Standard Deviation 21.267
|
21.13 percentage of total RPE attenuation
Standard Deviation 18.674
|
39.11 percentage of total RPE attenuation
Standard Deviation 27.628
|
—
|
32.12 percentage of total RPE attenuation
Standard Deviation 28.775
|
46.58 percentage of total RPE attenuation
Standard Deviation 43.859
|
38.98 percentage of total RPE attenuation
Standard Deviation 66.640
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 52 and Week 104Population: All participants in FAS (all randomized participants who received at least 1 dose \[full/partial\] of study drug grouped by randomized treatment) with both baseline and postbaseline (Week 52 and Week 104) visit central macular 2 mm subfield total RPE attenuation data. As prespecified, data were collected and reported for participants. Hence, 'Ns' reported below= number of participants analyzed regardless of which eye was evaluated. Number analyzed= participants evaluable for specified categories.
The percentage of total attenuation of the RPE in the central macular 2 mm subfield is reported.
Outcome measures
| Measure |
Danicopan 100 mg BID
n=72 Participants
Participants received danicopan 100 mg BID during the 104-week Masked Treatment Period.
|
Danicopan 200 mg BID
n=65 Participants
Participants received danicopan 200 mg BID during the 104-week Masked Treatment Period.
|
Danicopan 400 mg QD
n=72 Participants
Participants received danicopan 400 mg QD during the 104-week Masked Treatment Period.
|
Placebo
n=70 Participants
Participants received matching placebo and were re-randomized to one of the active treatment groups at Week 52.
|
Placebo - Danicopan 200 mg BID
n=24 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 200 mg BID for the remainder of the study.
|
Placebo - Danicopan 400 mg QD
n=23 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
Placebo - Danicopan 400 mg QD
n=23 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 100 mg BID
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 100 mg BID for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 200 mg BID
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 200 mg BID for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 400 mg QD
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to Week 52 and Week 104 in Percent Central Macular 2 mm Subfield Total RPE Attenuation in the Study Eye, Fellow Eye and Both Eyes Combined as Measured by SD-OCT
Study Eye: Change at Week 52
|
11.07 percentage of total RPE attenuation
Standard Deviation 8.790
|
10.86 percentage of total RPE attenuation
Standard Deviation 7.042
|
11.21 percentage of total RPE attenuation
Standard Deviation 8.539
|
10.18 percentage of total RPE attenuation
Standard Deviation 9.265
|
12.20 percentage of total RPE attenuation
Standard Deviation 9.228
|
8.89 percentage of total RPE attenuation
Standard Deviation 8.759
|
9.41 percentage of total RPE attenuation
Standard Deviation 9.869
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Percent Central Macular 2 mm Subfield Total RPE Attenuation in the Study Eye, Fellow Eye and Both Eyes Combined as Measured by SD-OCT
Study Eye: Change at Week 104
|
22.11 percentage of total RPE attenuation
Standard Deviation 18.777
|
20.14 percentage of total RPE attenuation
Standard Deviation 11.243
|
22.35 percentage of total RPE attenuation
Standard Deviation 9.980
|
—
|
14.87 percentage of total RPE attenuation
Standard Deviation 10.962
|
20.32 percentage of total RPE attenuation
Standard Deviation 5.212
|
13.47 percentage of total RPE attenuation
Standard Deviation 11.872
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Percent Central Macular 2 mm Subfield Total RPE Attenuation in the Study Eye, Fellow Eye and Both Eyes Combined as Measured by SD-OCT
Fellow Eye: Change at Week 52
|
8.84 percentage of total RPE attenuation
Standard Deviation 9.019
|
8.99 percentage of total RPE attenuation
Standard Deviation 11.116
|
10.56 percentage of total RPE attenuation
Standard Deviation 9.026
|
11.50 percentage of total RPE attenuation
Standard Deviation 8.889
|
11.30 percentage of total RPE attenuation
Standard Deviation 7.522
|
8.36 percentage of total RPE attenuation
Standard Deviation 7.234
|
14.38 percentage of total RPE attenuation
Standard Deviation 10.698
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Percent Central Macular 2 mm Subfield Total RPE Attenuation in the Study Eye, Fellow Eye and Both Eyes Combined as Measured by SD-OCT
Fellow Eye: Change at Week 104
|
17.54 percentage of total RPE attenuation
Standard Deviation 13.638
|
12.04 percentage of total RPE attenuation
Standard Deviation 10.432
|
20.96 percentage of total RPE attenuation
Standard Deviation 12.092
|
—
|
22.81 percentage of total RPE attenuation
Standard Deviation 19.741
|
26.77 percentage of total RPE attenuation
Standard Deviation 6.514
|
26.85 percentage of total RPE attenuation
Standard Deviation 20.134
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Percent Central Macular 2 mm Subfield Total RPE Attenuation in the Study Eye, Fellow Eye and Both Eyes Combined as Measured by SD-OCT
Both Eyes Combined: Change at Week 52
|
18.22 percentage of total RPE attenuation
Standard Deviation 13.985
|
17.22 percentage of total RPE attenuation
Standard Deviation 13.792
|
20.75 percentage of total RPE attenuation
Standard Deviation 13.888
|
19.74 percentage of total RPE attenuation
Standard Deviation 14.674
|
21.58 percentage of total RPE attenuation
Standard Deviation 14.796
|
15.43 percentage of total RPE attenuation
Standard Deviation 11.951
|
22.13 percentage of total RPE attenuation
Standard Deviation 16.571
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Percent Central Macular 2 mm Subfield Total RPE Attenuation in the Study Eye, Fellow Eye and Both Eyes Combined as Measured by SD-OCT
Both Eyes Combined: Change at Week 104
|
33.38 percentage of total RPE attenuation
Standard Deviation 19.938
|
27.94 percentage of total RPE attenuation
Standard Deviation 19.154
|
42.14 percentage of total RPE attenuation
Standard Deviation 18.854
|
—
|
33.88 percentage of total RPE attenuation
Standard Deviation 27.642
|
41.73 percentage of total RPE attenuation
Standard Deviation 15.668
|
40.32 percentage of total RPE attenuation
Standard Deviation 28.798
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 52 and Week 104Population: All participants in the FAS (all randomized participants who received at least 1 dose \[full or partial\] of study drug grouped by randomized treatment group) with both baseline and post-baseline (Week 52 and Week 104) visit BCVA score data. As prespecified, data were collected and reported for participants. Therefore, 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated. Number analyzed = participants evaluable at specified timepoints.
ETDRS charts present a series of five letters of equal difficulty on each row, with standardized spacing between letters and rows; there is a total of 14 lines (70 letters), with letter size increasing further geometrically and equivalently in every line by a factor of 1.2589 (or 0.1 log unit), moving up the chart. Minimum score of zero, maximum score of 100. Change from baseline: a more negative score is worse outcome, a more positive score is better outcome. A lower score means less letters were read correctly (worse outcome) and a higher score means more letters were read correctly (better outcome).
Outcome measures
| Measure |
Danicopan 100 mg BID
n=73 Participants
Participants received danicopan 100 mg BID during the 104-week Masked Treatment Period.
|
Danicopan 200 mg BID
n=68 Participants
Participants received danicopan 200 mg BID during the 104-week Masked Treatment Period.
|
Danicopan 400 mg QD
n=75 Participants
Participants received danicopan 400 mg QD during the 104-week Masked Treatment Period.
|
Placebo
n=70 Participants
Participants received matching placebo and were re-randomized to one of the active treatment groups at Week 52.
|
Placebo - Danicopan 200 mg BID
n=24 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 200 mg BID for the remainder of the study.
|
Placebo - Danicopan 400 mg QD
n=23 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
Placebo - Danicopan 400 mg QD
n=23 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 100 mg BID
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 100 mg BID for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 200 mg BID
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 200 mg BID for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 400 mg QD
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to Week 52 and Week 104 in Monocular Best-corrected Visual Acuity (BCVA) Scores in the Study Eye as Assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) Chart
Change at Week 104
|
-1.3 letters
Standard Deviation 4.71
|
-2.2 letters
Standard Deviation 12.30
|
-10.2 letters
Standard Deviation 16.37
|
—
|
-2.7 letters
Standard Deviation 6.62
|
-3.2 letters
Standard Deviation 5.54
|
-5.4 letters
Standard Deviation 6.39
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Monocular Best-corrected Visual Acuity (BCVA) Scores in the Study Eye as Assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) Chart
Change at Week 52
|
-2.2 letters
Standard Deviation 8.56
|
-2.0 letters
Standard Deviation 9.39
|
-3.5 letters
Standard Deviation 11.35
|
-1.8 letters
Standard Deviation 5.60
|
-2.4 letters
Standard Deviation 5.74
|
-2.0 letters
Standard Deviation 4.39
|
-0.9 letters
Standard Deviation 6.58
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 52 and Week 104Population: All participants in the FAS (all randomized participants who received at least 1 dose \[full or partial\] of study drug grouped by randomized treatment group) with both baseline and post-baseline (Week 52 and Week 104) visit LLVA score data. As prespecified, data were collected and reported for participants. Therefore, 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated. Number analyzed = participants evaluable at specified timepoints.
LLVA was measured by placing a 2.0-log-unit neutral density filter over the front of each eye and having the participant read the normally illuminated ETDRS chart. LLVA was reported as number of letters read correctly by the participant using the ETDRS Scale (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or VA). An increase in the number of letters read correctly means that vision has improved. Change from baseline: a negative score indicates decline in LLVA.
Outcome measures
| Measure |
Danicopan 100 mg BID
n=74 Participants
Participants received danicopan 100 mg BID during the 104-week Masked Treatment Period.
|
Danicopan 200 mg BID
n=67 Participants
Participants received danicopan 200 mg BID during the 104-week Masked Treatment Period.
|
Danicopan 400 mg QD
n=72 Participants
Participants received danicopan 400 mg QD during the 104-week Masked Treatment Period.
|
Placebo
n=70 Participants
Participants received matching placebo and were re-randomized to one of the active treatment groups at Week 52.
|
Placebo - Danicopan 200 mg BID
n=24 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 200 mg BID for the remainder of the study.
|
Placebo - Danicopan 400 mg QD
n=23 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
Placebo - Danicopan 400 mg QD
n=22 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 100 mg BID
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 100 mg BID for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 200 mg BID
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 200 mg BID for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 400 mg QD
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to Week 52 and Week 104 in Monocular Low Luminance Visual Acuity (LLVA) Scores in the Study Eye as Assessed by the ETDRS Chart
Change at Week 52
|
-6.3 letters
Standard Deviation 11.61
|
-4.6 letters
Standard Deviation 11.77
|
-4.0 letters
Standard Deviation 11.23
|
-4.8 letters
Standard Deviation 15.96
|
-7.7 letters
Standard Deviation 13.43
|
-1.2 letters
Standard Deviation 17.90
|
-5.5 letters
Standard Deviation 16.71
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Monocular Low Luminance Visual Acuity (LLVA) Scores in the Study Eye as Assessed by the ETDRS Chart
Change at Week 104
|
-10.3 letters
Standard Deviation 14.27
|
-9.9 letters
Standard Deviation 14.15
|
-8.9 letters
Standard Deviation 10.39
|
—
|
-8.0 letters
Standard Deviation 10.37
|
-3.9 letters
Standard Deviation 20.88
|
-11.8 letters
Standard Deviation 15.86
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 52 and Week 104Population: All participants in the FAS (all randomized participants who received at least 1 dose \[full or partial\] of study drug grouped by randomized treatment group) with both baseline and post-baseline (Week 52 and Week 104) visit LLD score data. As prespecified, data were collected and reported for participants. Therefore, 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated. Number analyzed = participants evaluable at specified timepoints.
LLD score was calculated as the difference between BCVA and LLVA (BCVA-LLVA) scores. BCVA and LLVA were reported as the number of letters read correctly by the participant using the ETDRS Scale (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision. LLD is a measure of visual acuity impairment in low-light conditions. A higher LLD score indicates a greater difference between vision in bright and dim light, suggesting a more significant loss of visual function in low-luminance settings.
Outcome measures
| Measure |
Danicopan 100 mg BID
n=74 Participants
Participants received danicopan 100 mg BID during the 104-week Masked Treatment Period.
|
Danicopan 200 mg BID
n=67 Participants
Participants received danicopan 200 mg BID during the 104-week Masked Treatment Period.
|
Danicopan 400 mg QD
n=71 Participants
Participants received danicopan 400 mg QD during the 104-week Masked Treatment Period.
|
Placebo
n=70 Participants
Participants received matching placebo and were re-randomized to one of the active treatment groups at Week 52.
|
Placebo - Danicopan 200 mg BID
n=24 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 200 mg BID for the remainder of the study.
|
Placebo - Danicopan 400 mg QD
n=23 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
Placebo - Danicopan 400 mg QD
n=22 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 100 mg BID
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 100 mg BID for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 200 mg BID
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 200 mg BID for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 400 mg QD
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to Week 52 and Week 104 in Low Luminance Deficit (LLD) (BCVA-LLVA) Score in the Study Eye
Change at Week 52
|
4.3 letters
Standard Deviation 13.30
|
2.6 letters
Standard Deviation 13.68
|
0.3 letters
Standard Deviation 15.67
|
2.9 letters
Standard Deviation 15.18
|
5.3 letters
Standard Deviation 12.56
|
-0.8 letters
Standard Deviation 17.15
|
4.5 letters
Standard Deviation 15.84
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in Low Luminance Deficit (LLD) (BCVA-LLVA) Score in the Study Eye
Change at Week 104
|
5.6 letters
Standard Deviation 17.11
|
6.3 letters
Standard Deviation 15.22
|
0.5 letters
Standard Deviation 19.93
|
—
|
4.4 letters
Standard Deviation 13.83
|
-2.7 letters
Standard Deviation 24.00
|
9.3 letters
Standard Deviation 15.91
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 52 and Week 104Population: All participants in the FAS (all randomized participants who received at least 1 dose \[full or partial\] of study drug grouped by randomized treatment group) with both baseline and post-baseline (Week 52 and Week 104) visit reading speed data. As prespecified, data were collected and reported for participants. Therefore, 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated. Number analyzed = participants evaluable at specified timepoints.
MNRead acuity cards were continuous-text reading-acuity cards suitable for measuring the reading acuity and reading speed of normal and low-vision participants. The MNRead acuity cards consisted of single, simple sentences with equal numbers of characters. A stopwatch was used to record time to a tenth of a second. Sentences that could not be read or were not attempted due to vision should be recorded as 0 for time and 10 for errors. The Radner Reading Cards were suitable for measuring reading speed, reading visual acuity, and critical print size. The reading test was stopped when the reading time was longer than 20 seconds or when the participant was making severe errors. A negative change from baseline indicates a decrease in the monocular reading speed; disease worsening.
Outcome measures
| Measure |
Danicopan 100 mg BID
n=67 Participants
Participants received danicopan 100 mg BID during the 104-week Masked Treatment Period.
|
Danicopan 200 mg BID
n=62 Participants
Participants received danicopan 200 mg BID during the 104-week Masked Treatment Period.
|
Danicopan 400 mg QD
n=58 Participants
Participants received danicopan 400 mg QD during the 104-week Masked Treatment Period.
|
Placebo
n=56 Participants
Participants received matching placebo and were re-randomized to one of the active treatment groups at Week 52.
|
Placebo - Danicopan 200 mg BID
n=20 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 200 mg BID for the remainder of the study.
|
Placebo - Danicopan 400 mg QD
n=15 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
Placebo - Danicopan 400 mg QD
n=20 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 100 mg BID
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 100 mg BID for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 200 mg BID
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 200 mg BID for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 400 mg QD
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to Week 52 And Week 104 in Monocular Reading Speeds in the Study Eye as Assessed by Minnesota Low Vision Reading Test (MNRead) Acuity Charts or Radner Reading Charts
Change at Week 52
|
-137.36 words per minute (wpm)
Standard Deviation 1016.889
|
-19.80 words per minute (wpm)
Standard Deviation 42.134
|
-13.47 words per minute (wpm)
Standard Deviation 77.927
|
-14.55 words per minute (wpm)
Standard Deviation 81.313
|
16.22 words per minute (wpm)
Standard Deviation 104.097
|
-41.54 words per minute (wpm)
Standard Deviation 53.752
|
-30.46 words per minute (wpm)
Standard Deviation 61.042
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 And Week 104 in Monocular Reading Speeds in the Study Eye as Assessed by Minnesota Low Vision Reading Test (MNRead) Acuity Charts or Radner Reading Charts
Change at Week 104
|
16.04 words per minute (wpm)
Standard Deviation 142.422
|
-23.70 words per minute (wpm)
Standard Deviation 57.745
|
-29.01 words per minute (wpm)
Standard Deviation 65.896
|
—
|
-59.41 words per minute (wpm)
Standard Deviation 43.156
|
30.18 words per minute (wpm)
Standard Deviation 144.094
|
-47.13 words per minute (wpm)
Standard Deviation 71.218
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 52 and Week 104Population: All participants in the FAS (all randomized participants who received at least 1 dose \[full or partial\] of study drug grouped by randomized treatment group) with both baseline and post-baseline (Week 52 and Week 104) visit NEI VFQ-25 scores data. As prespecified, data were collected and reported for participants. Therefore, 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated. Number analyzed = participants evaluable at specified timepoints.
The NEI VFQ-25 instrument measures dimensions of self-reported vision-targeted health status of individuals with chronic eye conditions. The NEI VFQ-25 consists of 11 vision related domains: global vision rating, difficulty with near vision activities, difficulty with distance vision activities, limitations in social function related to vision, role limitations, dependency on others due to vision, mental health symptoms due to vision, driving difficulties, limitations with peripheral- and color-vision, and ocular pain. The NEI VFQ-25 also includes a single item measuring general health. A composite score averages the vision related domains and ranges from 0 (worse) to 100 (best). A higher score represents better functioning. A negative change from baseline indicates a decrease in the visual functioning; disease worsening.
Outcome measures
| Measure |
Danicopan 100 mg BID
n=73 Participants
Participants received danicopan 100 mg BID during the 104-week Masked Treatment Period.
|
Danicopan 200 mg BID
n=67 Participants
Participants received danicopan 200 mg BID during the 104-week Masked Treatment Period.
|
Danicopan 400 mg QD
n=75 Participants
Participants received danicopan 400 mg QD during the 104-week Masked Treatment Period.
|
Placebo
n=70 Participants
Participants received matching placebo and were re-randomized to one of the active treatment groups at Week 52.
|
Placebo - Danicopan 200 mg BID
n=24 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 200 mg BID for the remainder of the study.
|
Placebo - Danicopan 400 mg QD
n=23 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
Placebo - Danicopan 400 mg QD
n=23 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 100 mg BID
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 100 mg BID for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 200 mg BID
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 200 mg BID for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 400 mg QD
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to Week 52 and Week 104 in National Eye Institute Visual Function Questionnaire (NEI VFQ-25) Composite Scores
Change at Week 52
|
-0.425 units on a scale
Standard Deviation 9.6019
|
-5.816 units on a scale
Standard Deviation 11.9162
|
-4.456 units on a scale
Standard Deviation 9.4963
|
-1.578 units on a scale
Standard Deviation 11.0757
|
-1.058 units on a scale
Standard Deviation 9.1822
|
-4.856 units on a scale
Standard Deviation 11.4575
|
1.156 units on a scale
Standard Deviation 12.0823
|
—
|
—
|
—
|
|
Change From Baseline to Week 52 and Week 104 in National Eye Institute Visual Function Questionnaire (NEI VFQ-25) Composite Scores
Change at Week 104
|
-7.676 units on a scale
Standard Deviation 16.3251
|
-8.478 units on a scale
Standard Deviation 13.5192
|
-7.454 units on a scale
Standard Deviation 14.2207
|
—
|
-0.332 units on a scale
Standard Deviation 13.3618
|
0.535 units on a scale
Standard Deviation 10.7239
|
-9.944 units on a scale
Standard Deviation 13.4043
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Week 52Population: Pharmacokinetic (PK) Analysis Set included all participants who received at least 1 dose (full or partial) of study drug and had at least 1 measurable concentration value. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.
All values below the limit of quantification (\<0.1 nanograms \[ng\]/milliliter \[mL\]) were set to 0 for calculation of summary statistics.
Outcome measures
| Measure |
Danicopan 100 mg BID
n=91 Participants
Participants received danicopan 100 mg BID during the 104-week Masked Treatment Period.
|
Danicopan 200 mg BID
n=87 Participants
Participants received danicopan 200 mg BID during the 104-week Masked Treatment Period.
|
Danicopan 400 mg QD
n=89 Participants
Participants received danicopan 400 mg QD during the 104-week Masked Treatment Period.
|
Placebo
Participants received matching placebo and were re-randomized to one of the active treatment groups at Week 52.
|
Placebo - Danicopan 200 mg BID
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 200 mg BID for the remainder of the study.
|
Placebo - Danicopan 400 mg QD
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
Placebo - Danicopan 400 mg QD
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 100 mg BID
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 100 mg BID for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 200 mg BID
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 200 mg BID for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 400 mg QD
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Plasma Concentration of Danicopan
Day 1: Predose
|
0.4 ng/mL
Standard Deviation 3.41
|
0 ng/mL
Standard Deviation 0
|
0.2 ng/mL
Standard Deviation 1.67
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Plasma Concentration of Danicopan
Day 1: 2 Hour Postdose
|
289.6 ng/mL
Standard Deviation 202.88
|
507.5 ng/mL
Standard Deviation 279.71
|
844.5 ng/mL
Standard Deviation 563.54
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Plasma Concentration of Danicopan
Week 52: Predose
|
62.5 ng/mL
Standard Deviation 40.64
|
127.7 ng/mL
Standard Deviation 100.78
|
88.1 ng/mL
Standard Deviation 138.95
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Plasma Concentration of Danicopan
Week 52: 2 Hour Postdose
|
381.6 ng/mL
Standard Deviation 219.22
|
704.4 ng/mL
Standard Deviation 336.37
|
919.5 ng/mL
Standard Deviation 709.94
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 52 (pre-dose, 2 hours post-dose)Population: Pharmacodynamic (PD) Analysis Set included all participants who received at least 1 dose (full or partial) of study drug and had at least 1 measurable PD value. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.
Serum AP functional activity was measured by the Wieslab functional immunoassay method.
Outcome measures
| Measure |
Danicopan 100 mg BID
n=67 Participants
Participants received danicopan 100 mg BID during the 104-week Masked Treatment Period.
|
Danicopan 200 mg BID
n=68 Participants
Participants received danicopan 200 mg BID during the 104-week Masked Treatment Period.
|
Danicopan 400 mg QD
n=70 Participants
Participants received danicopan 400 mg QD during the 104-week Masked Treatment Period.
|
Placebo
n=68 Participants
Participants received matching placebo and were re-randomized to one of the active treatment groups at Week 52.
|
Placebo - Danicopan 200 mg BID
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 200 mg BID for the remainder of the study.
|
Placebo - Danicopan 400 mg QD
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
Placebo - Danicopan 400 mg QD
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 100 mg BID
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 100 mg BID for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 200 mg BID
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 200 mg BID for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 400 mg QD
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Ex Vivo Serum Alternative Pathway (AP) Activity
Change at Week 52: Predose
|
-5.9 percentage of activity
Standard Deviation 17.49
|
-21.3 percentage of activity
Standard Deviation 29.90
|
-8.2 percentage of activity
Standard Deviation 24.48
|
2.7 percentage of activity
Standard Deviation 17.12
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Ex Vivo Serum Alternative Pathway (AP) Activity
Change at Week 52: 2 Hour Postdose
|
-58.5 percentage of activity
Standard Deviation 27.85
|
-75.3 percentage of activity
Standard Deviation 23.17
|
-74.8 percentage of activity
Standard Deviation 28.82
|
-23.1 percentage of activity
Standard Deviation 42.12
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 52 (pre-dose)Population: PD Analysis Set included all participants who received at least 1 dose (full or partial) of study drug and had at least 1 measurable PD value. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Outcome measures
| Measure |
Danicopan 100 mg BID
n=66 Participants
Participants received danicopan 100 mg BID during the 104-week Masked Treatment Period.
|
Danicopan 200 mg BID
n=65 Participants
Participants received danicopan 200 mg BID during the 104-week Masked Treatment Period.
|
Danicopan 400 mg QD
n=72 Participants
Participants received danicopan 400 mg QD during the 104-week Masked Treatment Period.
|
Placebo
n=70 Participants
Participants received matching placebo and were re-randomized to one of the active treatment groups at Week 52.
|
Placebo - Danicopan 200 mg BID
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 200 mg BID for the remainder of the study.
|
Placebo - Danicopan 400 mg QD
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
Placebo - Danicopan 400 mg QD
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 100 mg BID
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 100 mg BID for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 200 mg BID
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 200 mg BID for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 400 mg QD
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Plasma Bb Fragment of Complement Factor B (Bb) Concentration
|
-0.3 µg/mL
Standard Deviation 0.77
|
-0.7 µg/mL
Standard Deviation 0.94
|
-0.2 µg/mL
Standard Deviation 0.55
|
-0.1 µg/mL
Standard Deviation 0.55
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 through Week 108Population: Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
An adverse event (AE) was as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An SAE was an AE that met at least 1 of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization for the AE, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug), or an important medical event or reaction. A TEAE was defined as any AE that started during or after the first dose of study intervention. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Outcome measures
| Measure |
Danicopan 100 mg BID
n=93 Participants
Participants received danicopan 100 mg BID during the 104-week Masked Treatment Period.
|
Danicopan 200 mg BID
n=91 Participants
Participants received danicopan 200 mg BID during the 104-week Masked Treatment Period.
|
Danicopan 400 mg QD
n=91 Participants
Participants received danicopan 400 mg QD during the 104-week Masked Treatment Period.
|
Placebo
n=90 Participants
Participants received matching placebo and were re-randomized to one of the active treatment groups at Week 52.
|
Placebo - Danicopan 200 mg BID
n=73 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 200 mg BID for the remainder of the study.
|
Placebo - Danicopan 400 mg QD
n=67 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
Placebo - Danicopan 400 mg QD
n=73 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 100 mg BID
n=24 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 100 mg BID for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 200 mg BID
n=23 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 200 mg BID for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 400 mg QD
n=23 Participants
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Events Leading To Discontinuation of Study Drug Throughout the Study
SAEs
|
14 Participants
|
19 Participants
|
16 Participants
|
15 Participants
|
8 Participants
|
10 Participants
|
8 Participants
|
6 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Events Leading To Discontinuation of Study Drug Throughout the Study
Any TEAEs
|
79 Participants
|
83 Participants
|
76 Participants
|
71 Participants
|
51 Participants
|
37 Participants
|
46 Participants
|
19 Participants
|
12 Participants
|
17 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Events Leading To Discontinuation of Study Drug Throughout the Study
Events Leading To Discontinuation of Study Drug
|
11 Participants
|
15 Participants
|
9 Participants
|
11 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
Adverse Events
Primary Evaluation Period: Danicopan 100 mg BID
Primary Evaluation Period: Danicopan 200 mg BID
Primary Evaluation Period: Danicopan 400 mg QD
Primary Evaluation Period: Placebo
Secondary Evaluation Period: Danicopan 100 mg BID
Secondary Evaluation Period: Danicopan 200 mg BID
Secondary Evaluation Period: Danicopan 400 mg QD
Secondary Evaluation Period: Placebo - Danicopan 100 mg BID
Secondary Evaluation Period: Placebo - Danicopan 200 mg BID
Secondary Evaluation Period: Placebo - Danicopan 400 mg QD
Serious adverse events
| Measure |
Primary Evaluation Period: Danicopan 100 mg BID
n=93 participants at risk
Participants received danicopan 100 mg BID during the 52-week Primary Evaluation Period.
|
Primary Evaluation Period: Danicopan 200 mg BID
n=91 participants at risk
Participants received danicopan 200 mg BID during the 52-week Primary Evaluation Period.
|
Primary Evaluation Period: Danicopan 400 mg QD
n=91 participants at risk
Participants received danicopan 400 mg QD during the 52-week Primary Evaluation Period.
|
Primary Evaluation Period: Placebo
n=90 participants at risk
Participants received matching placebo during the 52-week Primary Evaluation Period.
|
Secondary Evaluation Period: Danicopan 100 mg BID
n=73 participants at risk
Participants received danicopan 100 mg BID during the 52-week Secondary Evaluation Period.
|
Secondary Evaluation Period: Danicopan 200 mg BID
n=67 participants at risk
Participants received danicopan 200 mg BID during the 52-week Secondary Evaluation Period.
|
Secondary Evaluation Period: Danicopan 400 mg QD
n=73 participants at risk
Participants received danicopan 400 mg QD during the 52-week Secondary Evaluation Period.
|
Secondary Evaluation Period: Placebo - Danicopan 100 mg BID
n=24 participants at risk
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 100 mg BID for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 200 mg BID
n=23 participants at risk
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 200 mg BID for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 400 mg QD
n=23 participants at risk
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Eye disorders
Macular hole
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.1%
1/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.1%
1/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.1%
1/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.1%
1/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.1%
1/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.4%
1/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Cardiac disorders
Atrial fibrillation
|
1.1%
1/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.1%
1/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.4%
1/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.1%
1/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.5%
1/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
4.2%
1/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.1%
1/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.1%
1/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.1%
1/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Ear and labyrinth disorders
Deafness unilateral
|
1.1%
1/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.1%
1/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.1%
1/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.1%
1/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
General disorders
Induration
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.1%
1/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
General disorders
Malaise
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.1%
1/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.1%
1/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.1%
1/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.1%
1/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Infections and infestations
COVID-19
|
1.1%
1/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
2.2%
2/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.4%
1/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.1%
1/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.1%
1/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.1%
1/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.4%
1/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Infections and infestations
Groin abscess
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.1%
1/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.1%
1/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Infections and infestations
Influenza
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.1%
1/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.1%
1/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
2.7%
2/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
4.2%
1/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.1%
1/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Infections and infestations
Respiratory tract infection bacterial
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.1%
1/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Infections and infestations
Sepsis
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.1%
1/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.4%
1/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Infections and infestations
Superinfection bacterial
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.1%
1/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.1%
1/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
4.1%
3/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
1.1%
1/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.1%
1/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.1%
1/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
4.2%
1/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
1.1%
1/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.1%
1/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.1%
1/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.1%
1/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Investigations
Hepatic enzyme increased
|
2.2%
2/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.1%
1/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
2.2%
2/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.1%
1/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.1%
1/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.1%
1/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.1%
1/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.1%
1/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.1%
1/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
3.0%
2/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.1%
1/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.1%
1/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
1.1%
1/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign salivary gland neoplasm
|
1.1%
1/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.1%
1/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.1%
1/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma stage IV
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.1%
1/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.1%
1/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.1%
1/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
1.1%
1/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.1%
1/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.1%
1/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.4%
1/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.1%
1/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.1%
1/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.4%
1/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.4%
1/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Psychiatric disorders
Disorientation
|
1.1%
1/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.1%
1/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Renal and urinary disorders
Renal failure
|
1.1%
1/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.1%
1/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.1%
1/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.1%
1/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.1%
1/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Vascular disorders
Hypertension
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.1%
1/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.1%
1/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Vascular disorders
Haematoma
|
1.1%
1/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Vascular disorders
Hypertensive emergency
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.1%
1/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Eye disorders
Neovascular age-related macular degeneration
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.1%
1/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
4.2%
1/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Infections and infestations
Endophthalmitis
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
4.3%
1/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.5%
1/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.5%
1/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
4.3%
1/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.5%
1/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
4.3%
1/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.4%
1/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.4%
1/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
4.2%
1/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
4.3%
1/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.5%
1/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
4.3%
1/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
4.2%
1/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
General disorders
Asthenia
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.4%
1/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.5%
1/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
4.3%
1/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Hepatobiliary disorders
Hydrocholecystis
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
4.3%
1/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.4%
1/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Infections and infestations
Diabetic foot infection
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
4.3%
1/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.4%
1/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.4%
1/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
3.0%
2/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.4%
1/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.4%
1/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.4%
1/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.4%
1/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Injury, poisoning and procedural complications
Traumatic arthrosis
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
4.3%
1/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.4%
1/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.5%
1/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.4%
1/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.5%
1/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.4%
1/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
4.2%
1/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.5%
1/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm malignant
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.5%
1/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
4.3%
1/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.4%
1/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Nervous system disorders
Syncope
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.5%
1/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.5%
1/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Product Issues
Device breakage
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.5%
1/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.4%
1/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.4%
1/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
Other adverse events
| Measure |
Primary Evaluation Period: Danicopan 100 mg BID
n=93 participants at risk
Participants received danicopan 100 mg BID during the 52-week Primary Evaluation Period.
|
Primary Evaluation Period: Danicopan 200 mg BID
n=91 participants at risk
Participants received danicopan 200 mg BID during the 52-week Primary Evaluation Period.
|
Primary Evaluation Period: Danicopan 400 mg QD
n=91 participants at risk
Participants received danicopan 400 mg QD during the 52-week Primary Evaluation Period.
|
Primary Evaluation Period: Placebo
n=90 participants at risk
Participants received matching placebo during the 52-week Primary Evaluation Period.
|
Secondary Evaluation Period: Danicopan 100 mg BID
n=73 participants at risk
Participants received danicopan 100 mg BID during the 52-week Secondary Evaluation Period.
|
Secondary Evaluation Period: Danicopan 200 mg BID
n=67 participants at risk
Participants received danicopan 200 mg BID during the 52-week Secondary Evaluation Period.
|
Secondary Evaluation Period: Danicopan 400 mg QD
n=73 participants at risk
Participants received danicopan 400 mg QD during the 52-week Secondary Evaluation Period.
|
Secondary Evaluation Period: Placebo - Danicopan 100 mg BID
n=24 participants at risk
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 100 mg BID for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 200 mg BID
n=23 participants at risk
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 200 mg BID for the remainder of the study.
|
Secondary Evaluation Period: Placebo - Danicopan 400 mg QD
n=23 participants at risk
Participants who received placebo during the primary evaluation period (up to Week 52), were re-randomized to receive danicopan 400 mg QD for the remainder of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Investigations
Gamma-glutamyltransferase increased
|
9.7%
9/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
7.7%
7/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
5.5%
5/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
3.3%
3/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.4%
1/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.5%
1/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
12.5%
3/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
8.7%
2/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
13.0%
3/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Investigations
C-reactive protein increased
|
1.1%
1/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
3.3%
3/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
7.7%
7/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
6.7%
6/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
4.1%
3/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
3.0%
2/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
2.7%
2/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
12.5%
3/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
4.3%
1/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Investigations
Hepatic enzyme increased
|
5.4%
5/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
6.6%
6/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
4.4%
4/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.4%
1/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
4.2%
1/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
8.7%
2/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
8.7%
2/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Investigations
Blood alkaline phosphatase increased
|
4.3%
4/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
4.4%
4/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
5.5%
5/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.5%
1/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.4%
1/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
4.2%
1/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
4.3%
1/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Investigations
Alanine aminotransferase increased
|
5.4%
5/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
5.5%
5/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.1%
1/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
2.2%
2/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.4%
1/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.5%
1/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.4%
1/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
4.2%
1/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
4.3%
1/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
4.3%
1/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Eye disorders
Cataract
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
3.3%
3/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.1%
1/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
3.3%
3/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
4.5%
3/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
5.5%
4/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
4.2%
1/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Nervous system disorders
Headache
|
5.4%
5/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
4.4%
4/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
6.6%
6/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
2.2%
2/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.4%
1/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.5%
1/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
4.2%
1/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
4.3%
1/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Vascular disorders
Hypertension
|
6.5%
6/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
4.4%
4/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
3.3%
3/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
3.3%
3/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.4%
1/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
6.0%
4/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
2.7%
2/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
3.3%
3/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.1%
1/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.4%
1/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
4.2%
1/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
8.7%
2/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
General disorders
Pyrexia
|
0.00%
0/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
2.2%
2/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
5.5%
4/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
4.2%
1/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Eye disorders
Neovascular age-related macular degeneration
|
5.4%
5/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
5.5%
5/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
5.5%
5/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
3.3%
3/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
4.1%
3/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
3.0%
2/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.4%
1/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
4.2%
1/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
4.3%
1/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
4.3%
1/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Gastrointestinal disorders
Nausea
|
5.4%
5/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
3.3%
3/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
4.4%
4/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
3.3%
3/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
4.1%
3/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.5%
1/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
4.3%
1/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.4%
5/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.1%
1/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.1%
1/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.4%
1/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.5%
1/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.4%
1/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Infections and infestations
COVID-19
|
5.4%
5/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
7.7%
7/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
9.9%
9/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
8.9%
8/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
2.7%
2/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
4.5%
3/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
8.2%
6/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
4.2%
1/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
8.7%
2/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
8.7%
2/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Infections and infestations
Urinary tract infection
|
6.5%
6/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
6.6%
6/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
9.9%
9/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
5.6%
5/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
11.0%
8/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
3.0%
2/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
5.5%
4/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
12.5%
3/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
4.3%
1/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Infections and infestations
Nasopharyngitis
|
9.7%
9/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
5.5%
5/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
3.3%
3/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
8.9%
8/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
5.5%
4/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
4.5%
3/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
4.1%
3/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
8.3%
2/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
8.7%
2/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Injury, poisoning and procedural complications
Fall
|
2.2%
2/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.1%
1/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
2.2%
2/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
3.3%
3/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
8.2%
6/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.4%
1/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Injury, poisoning and procedural complications
Contusion
|
1.1%
1/93 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
3.3%
3/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
2.2%
2/91 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.1%
1/90 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
2.7%
2/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.5%
1/67 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/73 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
8.3%
2/24 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
0.00%
0/23 • Day 1 through Week 108
Safety Set included all participants who received at least 1 dose (full or partial) of study drug grouped by treatment actually received. 'Deaths' as the 'reason for study discontinuation' have been reported in the participant flow section and 'all deaths' have been reported in the 'All-cause mortality' section. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
Additional Information
Alexion Pharmaceuticals Inc.
Alexion Pharmaceuticals Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place