Trial Outcomes & Findings for Study of Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema (NCT NCT03481634)
NCT ID: NCT03481634
Last Updated: 2023-01-30
Results Overview
BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual Function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of 78 to 23 (approximate Snellen equivalent of 20/32 to 20/320) in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning. This endpoint was analyzed via the pairwise ANOVA method where the 2 dose groups of Brolucizumab are compared to Aflibercept.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
566 participants
Primary outcome timeframe
Baseline, Week 52
Results posted on
2023-01-30
Participant Flow
Participant milestones
| Measure |
Brolucizumab 3 mg
Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Brolucizumab 6 mg
Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Aflibercept 2 mg
Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
190
|
189
|
187
|
|
Overall Study
COMPLETED
|
157
|
154
|
153
|
|
Overall Study
NOT COMPLETED
|
33
|
35
|
34
|
Reasons for withdrawal
| Measure |
Brolucizumab 3 mg
Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Brolucizumab 6 mg
Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Aflibercept 2 mg
Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
16
|
19
|
14
|
|
Overall Study
Protocol Violation
|
1
|
0
|
1
|
|
Overall Study
Progressive disease
|
0
|
1
|
0
|
|
Overall Study
Physician Decision
|
3
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
4
|
4
|
|
Overall Study
Death
|
4
|
8
|
7
|
|
Overall Study
Adverse Event
|
6
|
3
|
7
|
Baseline Characteristics
Study of Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema
Baseline characteristics by cohort
| Measure |
Brolucizumab 3 mg
n=190 Participants
Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Brolucizumab 6 mg
n=189 Participants
Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Aflibercept 2 mg
n=187 Participants
Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks
|
Total
n=566 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
97 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
294 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
93 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
272 Participants
n=4 Participants
|
|
Age, Continuous
|
64.4 years
STANDARD_DEVIATION 9.76 • n=5 Participants
|
62.4 years
STANDARD_DEVIATION 10.14 • n=7 Participants
|
63.9 years
STANDARD_DEVIATION 10.09 • n=5 Participants
|
63.6 years
STANDARD_DEVIATION 10.01 • n=4 Participants
|
|
Sex: Female, Male
Female
|
71 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
211 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
119 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
355 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
76 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
151 Participants
n=5 Participants
|
158 Participants
n=7 Participants
|
152 Participants
n=5 Participants
|
461 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 52Population: Full analysis set (FAS) - Last observation carried forward (LOCF). This endpoint was analyzed via the pairwise ANOVA method where the 2 dose groups of Brolucizumab are compared to Aflibercept
BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual Function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of 78 to 23 (approximate Snellen equivalent of 20/32 to 20/320) in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning. This endpoint was analyzed via the pairwise ANOVA method where the 2 dose groups of Brolucizumab are compared to Aflibercept.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=190 Participants
Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Brolucizumab 6 mg
n=189 Participants
Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Aflibercept 2 mg
n=187 Participants
Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks
|
|---|---|---|---|
|
Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 52
LS mean estimate (Brolucizumab 3 mg vs. Aflibercept 2 mg)
|
7.3 Scores on a scale
Standard Error 0.66
|
—
|
10.6 Scores on a scale
Standard Error 0.67
|
|
Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 52
LS mean estimate (Brolucizumab 6 mg vs. Aflibercept 2 mg)
|
—
|
9.2 Scores on a scale
Standard Error 0.57
|
10.5 Scores on a scale
Standard Error 0.57
|
SECONDARY outcome
Timeframe: Baseline and Week 40 through Week 52 (average)Population: Full analysis set (FAS) - Observed. This endpoint was analyzed via the pairwise ANOVA method where the 2 dose groups of Brolucizumab are compared to Aflibercept
BCVA will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of 78 to 23 (per the inclusion criteria) (approximate Snellen equivalent of 20/32 to 20/320) in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning. This endpoint was analyzed via the pairwise ANOVA method where the 2 dose groups of Brolucizumab are compared to Aflibercept.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=190 Participants
Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Brolucizumab 6 mg
n=189 Participants
Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Aflibercept 2 mg
n=187 Participants
Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks
|
|---|---|---|---|
|
Average Change From Baseline in BCVA Over the Period Week 40 Through Week 52
LS mean estimate (Brolucizumab 3 mg vs. Aflibercept 2 mg)
|
7.0 Scores on a scale
Standard Error 0.63
|
—
|
10.5 Scores on a scale
Standard Error 0.64
|
|
Average Change From Baseline in BCVA Over the Period Week 40 Through Week 52
LS mean estimate (Brolucizumab 6 mg vs. Aflibercept 2 mg)
|
—
|
9.0 Scores on a scale
Standard Error 0.53
|
10.5 Scores on a scale
Standard Error 0.53
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Weeks 32, 36 and 48Population: FAS - Efficacy/Safety approach
Positive treatment status is defined as intravitreal (IVT) injections per planned dosing regimen \[every 12 weeks (q12w)\]. This outcome measure is pre-specified for brolucizumab treatment arms only.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=190 Participants
Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Brolucizumab 6 mg
n=189 Participants
Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Aflibercept 2 mg
Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks
|
|---|---|---|---|
|
Patients Maintained at q12w - Probability of Maintaining on q12w
Prob. of maintaining on q12w - Week 48
|
0.474 Probability
Interval 0.393 to 0.551
|
0.550 Probability
Interval 0.468 to 0.625
|
—
|
|
Patients Maintained at q12w - Probability of Maintaining on q12w
Prob. of maintaining on q12w - Week 0
|
1 Probability
CIs are not applicable for probability = 1.
|
1 Probability
CIs are not applicable for probability = 1.
|
—
|
|
Patients Maintained at q12w - Probability of Maintaining on q12w
Prob. of maintaining on q12w - Week 32
|
0.758 Probability
Interval 0.685 to 0.816
|
0.807 Probability
Interval 0.739 to 0.86
|
—
|
|
Patients Maintained at q12w - Probability of Maintaining on q12w
Prob. of maintaining on q12w - Week 36
|
0.545 Probability
Interval 0.463 to 0.619
|
0.628 Probability
Interval 0.548 to 0.698
|
—
|
SECONDARY outcome
Timeframe: Weeks 36 and 48Population: FAS - Efficacy/Safety approach
Positive treatment status is defined as intravitreal (IVT) injections per planned dosing regimen \[every 8 weeks (q8w)\]. This outcome measure is pre-specified for brolucizumab treatment arms only.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=190 Participants
Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Brolucizumab 6 mg
n=189 Participants
Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Aflibercept 2 mg
Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks
|
|---|---|---|---|
|
Patients Maintained at q12w (for Those Patients Who Qualified for q12w at Week 36) - Probability of Maintaining on q12w
Prob. of maintaining on q12w - Week 36
|
1 Probability
CIs are not applicable for probability = 1.
|
1 Probability
CIs are not applicable for probability = 1.
|
—
|
|
Patients Maintained at q12w (for Those Patients Who Qualified for q12w at Week 36) - Probability of Maintaining on q12w
Prob. of maintaining on q12w - Week 48
|
0.870 Probability
Interval 0.772 to 0.928
|
0.876 Probability
Interval 0.788 to 0.93
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Weeks 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: Full analysis set (FAS)
BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of 78 to 23 (approximate Snellen equivalent of 20/32 to 20/320) in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=187 Participants
Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Brolucizumab 6 mg
n=186 Participants
Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Aflibercept 2 mg
n=185 Participants
Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks
|
|---|---|---|---|
|
Change From Baseline in BCVA at Each Visit up to Week 52
Week 4 (n=187, 186, 185)
|
4.0 Scores on a scale
Standard Deviation 5.02
|
4.5 Scores on a scale
Standard Deviation 5.22
|
5.1 Scores on a scale
Standard Deviation 6.74
|
|
Change From Baseline in BCVA at Each Visit up to Week 52
Week 18 (n=175,181,172)
|
7.6 Scores on a scale
Standard Deviation 6.35
|
8.0 Scores on a scale
Standard Deviation 6.84
|
8.8 Scores on a scale
Standard Deviation 7.27
|
|
Change From Baseline in BCVA at Each Visit up to Week 52
Week 24 (n=174,178,177)
|
8.1 Scores on a scale
Standard Deviation 6.42
|
9.3 Scores on a scale
Standard Deviation 7.08
|
9.2 Scores on a scale
Standard Deviation 7.84
|
|
Change From Baseline in BCVA at Each Visit up to Week 52
Week 52 (n=156,153,160)
|
7.8 Scores on a scale
Standard Deviation 10.72
|
10.2 Scores on a scale
Standard Deviation 7.66
|
10.7 Scores on a scale
Standard Deviation 8.87
|
|
Change From Baseline in BCVA at Each Visit up to Week 52
Week 6 (n=185,186,180)
|
5.1 Scores on a scale
Standard Deviation 5.86
|
6.0 Scores on a scale
Standard Deviation 6.22
|
6.8 Scores on a scale
Standard Deviation 6.80
|
|
Change From Baseline in BCVA at Each Visit up to Week 52
Week 8 (n=183,184,181)
|
5.6 Scores on a scale
Standard Deviation 5.90
|
6.6 Scores on a scale
Standard Deviation 6.54
|
7.1 Scores on a scale
Standard Deviation 7.57
|
|
Change From Baseline in BCVA at Each Visit up to Week 52
Week 12 (n=183,186,182)
|
6.7 Scores on a scale
Standard Deviation 5.93
|
7.3 Scores on a scale
Standard Deviation 6.57
|
8.1 Scores on a scale
Standard Deviation 7.63
|
|
Change From Baseline in BCVA at Each Visit up to Week 52
Week 16 (n=173,179,179)
|
7.0 Scores on a scale
Standard Deviation 7.00
|
7.5 Scores on a scale
Standard Deviation 6.83
|
8.5 Scores on a scale
Standard Deviation 7.36
|
|
Change From Baseline in BCVA at Each Visit up to Week 52
Week 20 (n=176,177,176)
|
7.8 Scores on a scale
Standard Deviation 7.59
|
8.3 Scores on a scale
Standard Deviation 7.51
|
9.8 Scores on a scale
Standard Deviation 7.47
|
|
Change From Baseline in BCVA at Each Visit up to Week 52
Week 28 (n=170,175,170)
|
8.2 Scores on a scale
Standard Deviation 6.58
|
9.6 Scores on a scale
Standard Deviation 7.40
|
10.3 Scores on a scale
Standard Deviation 7.26
|
|
Change From Baseline in BCVA at Each Visit up to Week 52
Week 32 (n=155,161,162)
|
8.2 Scores on a scale
Standard Deviation 7.76
|
9.2 Scores on a scale
Standard Deviation 7.20
|
9.9 Scores on a scale
Standard Deviation 7.89
|
|
Change From Baseline in BCVA at Each Visit up to Week 52
Week 36 (n=154,166,165)
|
6.9 Scores on a scale
Standard Deviation 8.10
|
8.6 Scores on a scale
Standard Deviation 8.15
|
10.2 Scores on a scale
Standard Deviation 7.84
|
|
Change From Baseline in BCVA at Each Visit up to Week 52
Week 40 (n=160,163,163)
|
7.3 Scores on a scale
Standard Deviation 10.47
|
9.5 Scores on a scale
Standard Deviation 7.99
|
10.0 Scores on a scale
Standard Deviation 8.28
|
|
Change From Baseline in BCVA at Each Visit up to Week 52
Week 44 (n=156,157,163)
|
7.5 Scores on a scale
Standard Deviation 10.92
|
9.6 Scores on a scale
Standard Deviation 7.66
|
10.7 Scores on a scale
Standard Deviation 8.25
|
|
Change From Baseline in BCVA at Each Visit up to Week 52
Week 48 (n=155,154,159)
|
7.2 Scores on a scale
Standard Deviation 11.53
|
10.0 Scores on a scale
Standard Deviation 7.63
|
11.1 Scores on a scale
Standard Deviation 8.75
|
SECONDARY outcome
Timeframe: Baseline, and Week 88 through Week 100 (average)Population: Full Analysis Set - LOCF
Visual acuity was assessed at every study visit using best correction determined from protocol refraction (BCVA). BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts. LS Mean estimates are reported, comparing the 2 Brolucizumab arms to Aflibercept. Results do not apply to the Brolucizumab 6 mg arm when Brolucizumab 3mg is compared to Aflibercept. Likewise, results do not apply to the Brolucizumab 3 mg arm when Brolucizumab 6 mg is compared to Aflibercept.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=190 Participants
Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Brolucizumab 6 mg
n=189 Participants
Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Aflibercept 2 mg
n=187 Participants
Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks
|
|---|---|---|---|
|
BCVA (Letters Read): ANOVA Results for Average Change From Baseline Over the Period Week 88 Through Week 100 for the Study Eye (FAS - LOCF)
LS mean estimate (Brolucizumab 6 mg vs Aflibercept 2 mg) (n=0, 189,187)
|
—
|
8.6 BCVA letters read
Standard Error 0.72
|
10.6 BCVA letters read
Standard Error 0.73
|
|
BCVA (Letters Read): ANOVA Results for Average Change From Baseline Over the Period Week 88 Through Week 100 for the Study Eye (FAS - LOCF)
LS mean estimate (Brolucizumab 3 mg vs Aflibercept 2 mg) (n=190, 0, 187)
|
6.7 BCVA letters read
Standard Error 0.77
|
—
|
10.6 BCVA letters read
Standard Error 0.78
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Weeks 32, 36, 48, 60, 72, 84, and 96Population: FAS - Efficacy/Safety approach
This outcome measure is pre-specified for brolucizumab treatment arms only
Outcome measures
| Measure |
Brolucizumab 3 mg
n=190 Participants
Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Brolucizumab 6 mg
n=189 Participants
Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Aflibercept 2 mg
Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks
|
|---|---|---|---|
|
Patients Maintained at q12w up to Week 64 (After Three q12w- Treatment Intervals) and Week 100 - Probability of Maintaining on q12w
Prob. of maintaining on q12w - Week 0
|
1 Probability
Not applicable when probability = 1
|
1 Probability
Not applicable when probability = 1
|
—
|
|
Patients Maintained at q12w up to Week 64 (After Three q12w- Treatment Intervals) and Week 100 - Probability of Maintaining on q12w
Prob. of maintaining on q12w - Week 32
|
0.758 Probability
Interval 0.685 to 0.816
|
0.807 Probability
Interval 0.739 to 0.86
|
—
|
|
Patients Maintained at q12w up to Week 64 (After Three q12w- Treatment Intervals) and Week 100 - Probability of Maintaining on q12w
Prob. of maintaining on q12w - Week 36
|
0.545 Probability
Interval 0.463 to 0.619
|
0.628 Probability
Interval 0.548 to 0.698
|
—
|
|
Patients Maintained at q12w up to Week 64 (After Three q12w- Treatment Intervals) and Week 100 - Probability of Maintaining on q12w
Prob. of maintaining on q12w - Week 48
|
0.474 Probability
Interval 0.393 to 0.551
|
0.550 Probability
Interval 0.468 to 0.625
|
—
|
|
Patients Maintained at q12w up to Week 64 (After Three q12w- Treatment Intervals) and Week 100 - Probability of Maintaining on q12w
Prob. of maintaining on q12w - Week 60
|
0.403 Probability
Interval 0.323 to 0.482
|
0.520 Probability
Interval 0.437 to 0.596
|
—
|
|
Patients Maintained at q12w up to Week 64 (After Three q12w- Treatment Intervals) and Week 100 - Probability of Maintaining on q12w
Prob. of maintaining on q12w - Week 72
|
0.394 Probability
Interval 0.314 to 0.473
|
0.487 Probability
Interval 0.404 to 0.565
|
—
|
|
Patients Maintained at q12w up to Week 64 (After Three q12w- Treatment Intervals) and Week 100 - Probability of Maintaining on q12w
Prob. of maintaining on q12w - Week 84
|
0.365 Probability
Interval 0.285 to 0.445
|
0.460 Probability
Interval 0.376 to 0.539
|
—
|
|
Patients Maintained at q12w up to Week 64 (After Three q12w- Treatment Intervals) and Week 100 - Probability of Maintaining on q12w
Prob. of maintaining on q12w - Week 96
|
0.334 Probability
Interval 0.254 to 0.415
|
0.441 Probability
Interval 0.357 to 0.521
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Weeks 32, 36, 48, 60, 72, 84, and 96Population: FAS - Efficacy/Safety approach
This outcome measure is pre-specified for brolucizumab treatment arms only
Outcome measures
| Measure |
Brolucizumab 3 mg
n=190 Participants
Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Brolucizumab 6 mg
n=189 Participants
Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Aflibercept 2 mg
Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks
|
|---|---|---|---|
|
Secondary: Patients Maintained at q12w up to Week 64 (After Three q12w- Treatment Intervals) and Week 100, Within Those Patients That Qualified for q12w at Week 36 - Probability of Maintaining on q12w
Prob. of maintaining on q12w - Week 60
|
0.740 Probability
Interval 0.622 to 0.826
|
0.828 Probability
Interval 0.73 to 0.892
|
—
|
|
Secondary: Patients Maintained at q12w up to Week 64 (After Three q12w- Treatment Intervals) and Week 100, Within Those Patients That Qualified for q12w at Week 36 - Probability of Maintaining on q12w
Prob. of maintaining on q12w - Week 72
|
0.723 Probability
Interval 0.603 to 0.812
|
0.775 Probability
Interval 0.67 to 0.851
|
—
|
|
Secondary: Patients Maintained at q12w up to Week 64 (After Three q12w- Treatment Intervals) and Week 100, Within Those Patients That Qualified for q12w at Week 36 - Probability of Maintaining on q12w
Prob. of maintaining on q12w - Week 84
|
0.670 Probability
Interval 0.544 to 0.769
|
0.732 Probability
Interval 0.621 to 0.816
|
—
|
|
Secondary: Patients Maintained at q12w up to Week 64 (After Three q12w- Treatment Intervals) and Week 100, Within Those Patients That Qualified for q12w at Week 36 - Probability of Maintaining on q12w
Prob. of maintaining on q12w - Week 0
|
1 Probability
Not applicable when probability = 1
|
1 Probability
Not applicable when probability = 1
|
—
|
|
Secondary: Patients Maintained at q12w up to Week 64 (After Three q12w- Treatment Intervals) and Week 100, Within Those Patients That Qualified for q12w at Week 36 - Probability of Maintaining on q12w
Prob. of maintaining on q12w - Week 32
|
1 Probability
Not applicable when probability = 1
|
1 Probability
Not applicable when probability = 1
|
—
|
|
Secondary: Patients Maintained at q12w up to Week 64 (After Three q12w- Treatment Intervals) and Week 100, Within Those Patients That Qualified for q12w at Week 36 - Probability of Maintaining on q12w
Prob. of maintaining on q12w - Week 36
|
1 Probability
Not applicable when probability = 1
|
1 Probability
Not applicable when probability = 1
|
—
|
|
Secondary: Patients Maintained at q12w up to Week 64 (After Three q12w- Treatment Intervals) and Week 100, Within Those Patients That Qualified for q12w at Week 36 - Probability of Maintaining on q12w
Prob. of maintaining on q12w - Week 48
|
0.870 Probability
Interval 0.772 to 0.928
|
0.876 Probability
Interval 0.788 to 0.93
|
—
|
|
Secondary: Patients Maintained at q12w up to Week 64 (After Three q12w- Treatment Intervals) and Week 100, Within Those Patients That Qualified for q12w at Week 36 - Probability of Maintaining on q12w
Prob. of maintaining on q12w - Week 96
|
0.613 Probability
Interval 0.482 to 0.72
|
0.702 Probability
Interval 0.587 to 0.791
|
—
|
SECONDARY outcome
Timeframe: Baseline up to week 52Population: Full analysis set (FAS) - Last observation carried forward (LOCF)
Central Subfield Thickness Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. LS Mean estimates are reported, comparing the 2 Brolucizumab arms to Aflibercept. Results do not apply to the Brolucizumab 6 mg arm when Brolucizumab 3mg is compared to Aflibercept. Likewise, results do not apply to the Brolucizumab 3 mg arm when Brolucizumab 6 mg is compared to Aflibercept.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=190 Participants
Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Brolucizumab 6 mg
n=189 Participants
Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Aflibercept 2 mg
n=187 Participants
Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks
|
|---|---|---|---|
|
Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results
LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 6 (n=190, 0, 187)
|
-107.1 μm
Standard Error 6.24
|
—
|
-119.3 μm
Standard Error 6.29
|
|
Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results
LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 8 (n=190, 0, 187)
|
-125.1 μm
Standard Error 6.06
|
—
|
-126.1 μm
Standard Error 6.11
|
|
Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results
LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg)- Week 8 (n=0, 189, 187)
|
—
|
-128.9 μm
Standard Error 5.82
|
-125.6 μm
Standard Error 5.86
|
|
Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results
LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 12 (n=190, 0, 187)
|
-131.0 μm
Standard Error 6.14
|
—
|
-137.4 μm
Standard Error 6.19
|
|
Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results
LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 52 (n=0, 189, 187)
|
—
|
-165.5 μm
Standard Error 6.17
|
-160.4 μm
Standard Error 6.21
|
|
Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results
LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 4 (n=190, 0, 187)
|
-104.7 μm
Standard Error 6.11
|
—
|
-104.1 μm
Standard Error 6.15
|
|
Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results
LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 4 (n=0, 189, 187)
|
—
|
-105.6 μm
Standard Error 5.92
|
-103.4 μm
Standard Error 5.95
|
|
Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results
LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 6 (n=0, 189, 187)
|
—
|
-116.1 μm
Standard Error 5.89
|
-118.6 μm
Standard Error 5.92
|
|
Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results
LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 12 (n=0, 189, 187)
|
—
|
-134.5 μm
Standard Error 6.22
|
-137.3 μm
Standard Error 6.26
|
|
Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results
LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 16 (n=190, 0, 187)
|
-142.3 μm
Standard Error 5.98
|
—
|
-143.3 μm
Standard Error 6.02
|
|
Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results
LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 16 (n=0, 189, 187)
|
—
|
-146.5 μm
Standard Error 5.83
|
-143.1 μm
Standard Error 5.86
|
|
Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results
LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 18 (n=190, 0, 187)
|
-138.1 μm
Standard Error 6.27
|
—
|
-147.0 μm
Standard Error 6.32
|
|
Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results
LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 18 (n=0, 189, 187)
|
—
|
-144.2 μm
Standard Error 5.96
|
-146.8 μm
Standard Error 5.99
|
|
Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results
LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 20 (n=190, 0, 187)
|
-151.8 μm
Standard Error 6.01
|
—
|
-148.3 μm
Standard Error 6.06
|
|
Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results
LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 20 (n=0, 189, 187)
|
—
|
-153.8 μm
Standard Error 5.71
|
-148.0 μm
Standard Error 5.74
|
|
Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results
LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 24 (n=190, 0, 187)
|
-152.6 μm
Standard Error 6.37
|
—
|
-138.7 μm
Standard Error 6.42
|
|
Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results
LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 24 (n=0, 189, 187)
|
—
|
-156.2 μm
Standard Error 6.30
|
-138.4 μm
Standard Error 6.33
|
|
Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results
LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 28 (n=190, 0, 187)
|
-163.4 μm
Standard Error 5.81
|
—
|
-154.6 μm
Standard Error 5.85
|
|
Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results
LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 28 (n=0, 189, 187)
|
—
|
-163.3 μm
Standard Error 5.97
|
-154.6 μm
Standard Error 6.00
|
|
Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results
LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 32 (n=190, 0, 187)
|
-147.4 μm
Standard Error 6.68
|
—
|
-144.3 μm
Standard Error 6.73
|
|
Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results
LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 32 (n=0, 189, 187)
|
—
|
-156.0 μm
Standard Error 6.35
|
-144.2 μm
Standard Error 6.38
|
|
Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results
LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 36 (n=190, 0, 187)
|
-119.8 μm
Standard Error 7.74
|
—
|
-156.0 μm
Standard Error 7.81
|
|
Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results
LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 36 (n=0, 189, 187)
|
—
|
-135.1 μm
Standard Error 7.01
|
-155.5 μm
Standard Error 7.05
|
|
Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results
LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 40 (n=190, 0, 187)
|
-155.8 μm
Standard Error 6.46
|
—
|
-149.7 μm
Standard Error 6.51
|
|
Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results
LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 40 (n=0, 189, 187)
|
—
|
-156.9 μm
Standard Error 6.68
|
-150.4 μm
Standard Error 6.72
|
|
Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results
LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 44 (n=190, 0, 187)
|
-155.4 μm
Standard Error 6.56
|
—
|
-163.4 μm
Standard Error 6.62
|
|
Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results
LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 44 (n=0, 189, 187)
|
—
|
-162.2 μm
Standard Error 6.17
|
-163.3 μm
Standard Error 6.21
|
|
Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results
LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 48 (n=190, 0, 187)
|
-144.2 μm
Standard Error 6.92
|
—
|
-157.8 μm
Standard Error 6.98
|
|
Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results
LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 48 (n=0, 189, 187)
|
—
|
-153.5 μm
Standard Error 6.52
|
-158.2 μm
Standard Error 6.55
|
|
Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results
LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 52 (n=190, 0, 187)
|
-156.4 μm
Standard Error 6.70
|
—
|
-160.7 μm
Standard Error 6.75
|
SECONDARY outcome
Timeframe: Baseline, and Week 88 through Week 100 (average)Population: Full Analysis Set - LOCF
Central subfield thickness (average thickness of circular 1mm area centered around fovea measured from RPE to ILM, inclusively). Assessed with Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. LS Mean estimates are reported, comparing the 2 Brolucizumab arms to Aflibercept. Results do not apply to the Brolucizumab 6 mg arm when Brolucizumab 3mg is compared to Aflibercept. Likewise, results do not apply to the Brolucizumab 3 mg arm when Brolucizumab 6 mg is compared to Aflibercept.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=190 Participants
Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Brolucizumab 6 mg
n=189 Participants
Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Aflibercept 2 mg
n=187 Participants
Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks
|
|---|---|---|---|
|
Central Subfield Thickness (CSFT) (Micrometers): ANOVA Results for Average Change From Baseline Over the Period Week 88 Through Week 100 for the Study Eye (Full Analysis Set - LOCF)
LS mean estimate (Brolucizumab 3 mg vs Aflibercept 2 mg) (n=190, 0, 187)
|
-167.1 micrometers
Standard Error 6.54
|
—
|
-168.8 micrometers
Standard Error 6.59
|
|
Central Subfield Thickness (CSFT) (Micrometers): ANOVA Results for Average Change From Baseline Over the Period Week 88 Through Week 100 for the Study Eye (Full Analysis Set - LOCF)
LS mean estimate (Brolucizumab 6 mg vs Aflibercept 2 mg) (n=0, 189,187)
|
—
|
-171.9 micrometers
Standard Error 6.18
|
-168.5 micrometers
Standard Error 6.22
|
SECONDARY outcome
Timeframe: Baseline up to Week 52 and Week 100Population: Full analysis set (FAS) - Last observation carried forward (LOCF)
Subretinal Fluid (SRF) status in the central subfield: proportion of subjects with presence of SRF in the study eye by visit
Outcome measures
| Measure |
Brolucizumab 3 mg
n=190 Participants
Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Brolucizumab 6 mg
n=189 Participants
Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Aflibercept 2 mg
n=187 Participants
Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks
|
|---|---|---|---|
|
Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit
Week 8
|
10 Participants
|
9 Participants
|
12 Participants
|
|
Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit
Week 20
|
5 Participants
|
4 Participants
|
6 Participants
|
|
Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit
Week 24
|
7 Participants
|
3 Participants
|
6 Participants
|
|
Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit
Week 28
|
5 Participants
|
2 Participants
|
3 Participants
|
|
Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit
Week 48
|
7 Participants
|
8 Participants
|
3 Participants
|
|
Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit
Week 4
|
26 Participants
|
23 Participants
|
27 Participants
|
|
Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit
Week 6
|
20 Participants
|
17 Participants
|
17 Participants
|
|
Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit
Week 12
|
11 Participants
|
8 Participants
|
8 Participants
|
|
Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit
Week16
|
6 Participants
|
6 Participants
|
7 Participants
|
|
Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit
Week18
|
7 Participants
|
4 Participants
|
6 Participants
|
|
Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit
Week 32
|
11 Participants
|
1 Participants
|
6 Participants
|
|
Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit
Week 36
|
16 Participants
|
14 Participants
|
4 Participants
|
|
Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit
Week 40
|
8 Participants
|
5 Participants
|
6 Participants
|
|
Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit
Week 44
|
4 Participants
|
4 Participants
|
4 Participants
|
|
Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit
Week 52
|
4 Participants
|
4 Participants
|
4 Participants
|
|
Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit
Week 56
|
9 Participants
|
3 Participants
|
5 Participants
|
|
Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit
Week 60
|
9 Participants
|
5 Participants
|
5 Participants
|
|
Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit
Week 64
|
6 Participants
|
4 Participants
|
5 Participants
|
|
Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit
Week 68
|
6 Participants
|
4 Participants
|
3 Participants
|
|
Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit
Week 72
|
5 Participants
|
4 Participants
|
4 Participants
|
|
Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit
Week 76
|
4 Participants
|
4 Participants
|
4 Participants
|
|
Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit
Week 80
|
5 Participants
|
4 Participants
|
5 Participants
|
|
Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit
Week 84
|
6 Participants
|
3 Participants
|
3 Participants
|
|
Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit
Week 88
|
7 Participants
|
2 Participants
|
4 Participants
|
|
Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit
Week 92
|
4 Participants
|
2 Participants
|
4 Participants
|
|
Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit
Week 96
|
5 Participants
|
3 Participants
|
5 Participants
|
|
Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit
Week 100
|
3 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline, up to Week 52 and Week 100Population: Full analysis set (FAS) - Last observation carried forward (LOCF)
Intraretinal Fluid (IRF) status in the central subfield: proportion of subjects with presence of IRF in the study eye by visit
Outcome measures
| Measure |
Brolucizumab 3 mg
n=190 Participants
Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Brolucizumab 6 mg
n=189 Participants
Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Aflibercept 2 mg
n=187 Participants
Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks
|
|---|---|---|---|
|
Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit
Week 8
|
166 Participants
|
161 Participants
|
164 Participants
|
|
Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit
Week 6
|
177 Participants
|
169 Participants
|
169 Participants
|
|
Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit
Week 28
|
139 Participants
|
130 Participants
|
144 Participants
|
|
Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit
Week 32
|
143 Participants
|
131 Participants
|
156 Participants
|
|
Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit
Week 36
|
153 Participants
|
141 Participants
|
144 Participants
|
|
Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit
Week 44
|
127 Participants
|
118 Participants
|
135 Participants
|
|
Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit
Week 48
|
132 Participants
|
123 Participants
|
147 Participants
|
|
Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit
Week 56
|
111 Participants
|
103 Participants
|
138 Participants
|
|
Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit
Week 60
|
119 Participants
|
115 Participants
|
126 Participants
|
|
Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit
Week 68
|
109 Participants
|
98 Participants
|
118 Participants
|
|
Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit
Week 72
|
107 Participants
|
103 Participants
|
126 Participants
|
|
Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit
Week 76
|
98 Participants
|
96 Participants
|
118 Participants
|
|
Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit
Week 80
|
96 Participants
|
85 Participants
|
120 Participants
|
|
Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit
Week 92
|
91 Participants
|
86 Participants
|
105 Participants
|
|
Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit
Week 4
|
176 Participants
|
169 Participants
|
169 Participants
|
|
Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit
Week 12
|
167 Participants
|
162 Participants
|
165 Participants
|
|
Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit
Week 16
|
155 Participants
|
150 Participants
|
156 Participants
|
|
Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit
Week 18
|
152 Participants
|
149 Participants
|
154 Participants
|
|
Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit
Week 20
|
142 Participants
|
147 Participants
|
145 Participants
|
|
Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit
Week 24
|
142 Participants
|
140 Participants
|
153 Participants
|
|
Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit
Week 40
|
129 Participants
|
114 Participants
|
150 Participants
|
|
Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit
Week 52
|
113 Participants
|
114 Participants
|
137 Participants
|
|
Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit
Week 64
|
102 Participants
|
105 Participants
|
131 Participants
|
|
Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit
Week 84
|
102 Participants
|
92 Participants
|
108 Participants
|
|
Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit
Week 88
|
89 Participants
|
85 Participants
|
114 Participants
|
|
Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit
Week 96
|
92 Participants
|
90 Participants
|
107 Participants
|
|
Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit
Week 100
|
87 Participants
|
79 Participants
|
101 Participants
|
SECONDARY outcome
Timeframe: Baseline, up to Week 52 and Week 100Population: Full analysis set (FAS) - Last observation carried forward (LOCF)
Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) status in the central subfield: proportion of subjects with presence of SRF and/or IRF in the study eye by visit
Outcome measures
| Measure |
Brolucizumab 3 mg
n=190 Participants
Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Brolucizumab 6 mg
n=189 Participants
Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Aflibercept 2 mg
n=187 Participants
Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks
|
|---|---|---|---|
|
Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit
Week 100
|
87 Participants
|
79 Participants
|
101 Participants
|
|
Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit
Week 88
|
89 Participants
|
85 Participants
|
114 Participants
|
|
Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit
Week 92
|
91 Participants
|
86 Participants
|
105 Participants
|
|
Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit
Week 96
|
92 Participants
|
90 Participants
|
107 Participants
|
|
Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit
Week 16
|
156 Participants
|
150 Participants
|
156 Participants
|
|
Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit
Week 24
|
142 Participants
|
140 Participants
|
153 Participants
|
|
Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit
Week 40
|
129 Participants
|
114 Participants
|
150 Participants
|
|
Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit
Week 64
|
102 Participants
|
105 Participants
|
131 Participants
|
|
Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit
Week 4
|
177 Participants
|
172 Participants
|
171 Participants
|
|
Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit
Week 6
|
177 Participants
|
173 Participants
|
169 Participants
|
|
Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit
Week 8
|
166 Participants
|
162 Participants
|
164 Participants
|
|
Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit
Week 12
|
168 Participants
|
162 Participants
|
165 Participants
|
|
Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit
Week 18
|
153 Participants
|
149 Participants
|
154 Participants
|
|
Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit
Week 20
|
142 Participants
|
147 Participants
|
145 Participants
|
|
Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit
Week 28
|
139 Participants
|
130 Participants
|
144 Participants
|
|
Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit
Week 32
|
143 Participants
|
131 Participants
|
156 Participants
|
|
Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit
Week 36
|
153 Participants
|
141 Participants
|
144 Participants
|
|
Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit
Week 44
|
127 Participants
|
118 Participants
|
135 Participants
|
|
Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit
Week 48
|
132 Participants
|
123 Participants
|
147 Participants
|
|
Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit
Week 52
|
113 Participants
|
114 Participants
|
137 Participants
|
|
Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit
Week 56
|
111 Participants
|
103 Participants
|
138 Participants
|
|
Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit
Week 60
|
120 Participants
|
115 Participants
|
126 Participants
|
|
Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit
Week 68
|
109 Participants
|
98 Participants
|
118 Participants
|
|
Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit
Week 72
|
107 Participants
|
103 Participants
|
126 Participants
|
|
Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit
Week 76
|
98 Participants
|
96 Participants
|
118 Participants
|
|
Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit
Week 80
|
96 Participants
|
85 Participants
|
120 Participants
|
|
Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit
Week 84
|
102 Participants
|
92 Participants
|
108 Participants
|
SECONDARY outcome
Timeframe: Week 52Population: Full analysis set (FAS) - Last observation carried forward (LOCF). The angiogram results are not available at baseline on all participants because in rare cases, the images could not be read e.g., because of poor quality.
Assessed by angiography.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=189 Participants
Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Brolucizumab 6 mg
n=188 Participants
Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Aflibercept 2 mg
n=186 Participants
Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks
|
|---|---|---|---|
|
Number of Patients With Presence of Leakage on Fluorescein Angiography (FA) at Week 52
|
114 Participants
|
108 Participants
|
140 Participants
|
SECONDARY outcome
Timeframe: Week 100Population: Full analysis set (FAS) - Last observation carried forward (LOCF). The angiogram results are not available at baseline on all participants because in rare cases, the images could not be read e.g., because of poor quality.
Assessed by angiography.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=190 Participants
Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Brolucizumab 6 mg
n=188 Participants
Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Aflibercept 2 mg
n=186 Participants
Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks
|
|---|---|---|---|
|
Number of Patients With Presence of Leakage on Fluorescein Angiography (FA) at Week 100
|
94 Participants
|
80 Participants
|
104 Participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 28, 52, 76, 100Population: Full analysis set (FAS) - Last observation carried forward (LOCF). The results are not available at baseline on all participants because in rare cases, the images could not be read e.g., because of poor quality.
Severity of Diabetic Retinopathy (DR) was evaluated using the ETDRS DRSS score assessed by the Central Reading Center (CRC) based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR). A lower score represents better visual functioning.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=185 Participants
Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Brolucizumab 6 mg
n=186 Participants
Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Aflibercept 2 mg
n=184 Participants
Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks
|
|---|---|---|---|
|
Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Number of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Number of Subjects
Week 76
|
59 Participants
|
55 Participants
|
51 Participants
|
|
Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Number of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Number of Subjects
Week 28
|
44 Participants
|
49 Participants
|
39 Participants
|
|
Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Number of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Number of Subjects
Week 52
|
53 Participants
|
55 Participants
|
40 Participants
|
|
Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Number of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Number of Subjects
Week 100
|
60 Participants
|
61 Participants
|
54 Participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 28, 52, 76, 100Population: Full analysis set (FAS) - Last observation carried forward (LOCF). The results are not available at baseline on all participants because in rare cases, the images could not be read e.g., because of poor quality.
Severity of Diabetic Retinopathy (DR) was evaluated using the ETDRS DRSS score assessed by the Central Reading Center (CRC) based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR). A lower score represents better visual functioning. * estimates are reported, comparing the 2 Brolucizumab arms to Aflibercept. Results do not apply to the Brolucizumab 6 mg arm when Brolucizumab 3mg is compared to Aflibercept. Likewise, results do not apply to the Brolucizumab 3 mg arm when Brolucizumab 6 mg is compared to Aflibercept. * estimates represent the % of participants who were estimated to have a "\>=2-step Improvement From Baseline in the DRSS Score" from pairwise logistic regression models adjusting for baseline DRSS score categories (\<=4, ≥5), age categories (\<65, ≥65 years) and treatment as fixed effect factors. Abbreviation: Proportion Estimates = P.E.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=185 Participants
Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Brolucizumab 6 mg
n=186 Participants
Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Aflibercept 2 mg
n=184 Participants
Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks
|
|---|---|---|---|
|
Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates
Comparison of Brolucizumab 6 mg vs. Aflibercept 2 mg - P.E.(%) at Week 28 (n = 0, 186, 184)
|
—
|
25.8 Percentage estimates
|
21.7 Percentage estimates
|
|
Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates
Comparison of Brolucizumab 3 mg vs. Aflibercept 2 mg - P.E. (%) at Week 52 (n = 185,0, 184)
|
28.0 Percentage estimates
|
—
|
22.3 Percentage estimates
|
|
Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates
Comparison of Brolucizumab 6 mg vs. Aflibercept 2 mg - P.E.(%) at Week 76 (n = 0, 186, 184)
|
—
|
29.0 Percentage estimates
|
28.3 Percentage estimates
|
|
Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates
Comparison of Brolucizumab 3 mg vs. Aflibercept 2 mg - P.E. (%) at Week 28 (n = 185,0, 184)
|
23.3 Percentage estimates
|
—
|
21.7 Percentage estimates
|
|
Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates
Comparison of Brolucizumab 6 mg vs. Aflibercept 2 mg - P.E. (%) at Week 52 (n = 0, 186, 184)
|
—
|
29.0 Percentage estimates
|
22.2 Percentage estimates
|
|
Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates
Comparison of Brolucizumab 3 mg vs. Aflibercept 2 mg - P.E. (%) at Week 76 (n = 185,0, 184)
|
31.2 Percentage estimates
|
—
|
28.4 Percentage estimates
|
|
Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates
Comparison of Brolucizumab 3 mg vs. Aflibercept 2 mg - P.E. (%) at Week 100 (n = 185,0, 184)
|
31.7 Percentage estimates
|
—
|
30.1 Percentage estimates
|
|
Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates
Comparison of Brolucizumab 6 mg vs. Aflibercept 2 mg - P.E.(%) at Week 100 (n = 0, 186, 184)
|
—
|
32.1 Percentage estimates
|
30.0 Percentage estimates
|
SECONDARY outcome
Timeframe: Baseline, Weeks 28, 52, 76, 100Population: Full analysis set (FAS) - Last observation carried forward (LOCF). The results are not available at baseline on all participants because in rare cases, the images could not be read e.g., because of poor quality.
Severity of Diabetic Retinopathy (DR) was evaluated using the ETDRS DRSS score assessed by the Central Reading Center (CRC) based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR). A lower score represents better visual functioning.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=185 Participants
Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Brolucizumab 6 mg
n=186 Participants
Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Aflibercept 2 mg
n=184 Participants
Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks
|
|---|---|---|---|
|
Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Number of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Number of Subjects
Week 52
|
24 Participants
|
39 Participants
|
30 Participants
|
|
Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Number of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Number of Subjects
Week 28
|
23 Participants
|
32 Participants
|
22 Participants
|
|
Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Number of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Number of Subjects
Week 76
|
27 Participants
|
40 Participants
|
42 Participants
|
|
Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Number of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Number of Subjects
Week 100
|
29 Participants
|
44 Participants
|
41 Participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 28, 52, 76, 100Population: Full analysis set (FAS) - Last observation carried forward (LOCF). The results are not available at baseline on all participants because in rare cases, the images could not be read e.g., because of poor quality.
Severity of Diabetic Retinopathy (DR) was evaluated using the ETDRS DRSS score assessed by the Central Reading Center (CRC) based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR). A lower score represents better visual functioning. * estimates are reported, comparing the 2 Brolucizumab arms to Aflibercept. Results do not apply to the Brolucizumab 6 mg arm when Brolucizumab 3mg is compared to Aflibercept. Likewise, results do not apply to the Brolucizumab 3 mg arm when Brolucizumab 6 mg is compared to Aflibercept. * estimates represent the % of participants who were estimated to have a "\>=3-step Improvement From Baseline in the DRSS Score" from pairwise logistic regression models adjusting for baseline DRSS score categories (\<=4, ≥5), age categories (\<65, ≥65 years) and treatment as fixed effect factors. Abbreviation: Proportion Estimates = P.E.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=185 Participants
Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Brolucizumab 6 mg
n=186 Participants
Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Aflibercept 2 mg
n=184 Participants
Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks
|
|---|---|---|---|
|
Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates
Comparison of Brolucizumab 3 mg vs. Aflibercept 2 mg - P.E. (%) at Week 28 (n = 185, 0, 184)
|
12.1 Percentage estimates
|
—
|
12.3 Percentage estimates
|
|
Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates
Comparison of Brolucizumab 3 mg vs. Aflibercept 2 mg - P.E.(%) at Week 52 (n = 185, 0, 184)
|
12.6 Percentage estimates
|
—
|
16.8 Percentage estimates
|
|
Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates
Comparison of Brolucizumab 3 mg vs. Aflibercept 2 mg - P.E. (%) at Week 76 (n = 185, 0, 184)
|
14.2 Percentage estimates
|
—
|
23.4 Percentage estimates
|
|
Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates
Comparison of Brolucizumab 6 mg vs. Aflibercept 2 mg - P.E. (%) at Week 100 (n = 0, 186, 184)
|
—
|
23.2 Percentage estimates
|
22.8 Percentage estimates
|
|
Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates
Comparison of Brolucizumab 6 mg vs. Aflibercept 2 mg - P.E. (%) at Week 28 (n = 0, 186, 184)
|
—
|
16.8 Percentage estimates
|
12.2 Percentage estimates
|
|
Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates
Comparison of Brolucizumab 6 mg vs. Aflibercept 2 mg - P.E. (%) at Week 52 (n = 0, 186, 184)
|
—
|
20.5 Percentage estimates
|
16.7 Percentage estimates
|
|
Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates
Comparison of Brolucizumab 6 mg vs. Aflibercept 2 mg - P.E. (%) at Week 76 (n = 0, 186, 184)
|
—
|
21.1 Percentage estimates
|
23.3 Percentage estimates
|
|
Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates
Comparison of Brolucizumab 3 mg vs. Aflibercept 2 mg - P.E. (%) at Week 100 (n = 185, 0, 184)
|
15.2 Percentage estimates
|
—
|
22.9 Percentage estimates
|
SECONDARY outcome
Timeframe: Baseline, Weeks 28, 52, 76, 100Population: FAS - Observed
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=165 Participants
Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Brolucizumab 6 mg
n=173 Participants
Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Aflibercept 2 mg
n=168 Participants
Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks
|
|---|---|---|---|
|
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Composite Score
Week 28
|
5.5 overall scores
Standard Deviation 11.89
|
6.0 overall scores
Standard Deviation 14.27
|
7.8 overall scores
Standard Deviation 12.68
|
|
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Composite Score
Week 52 (n = 151,148,157)
|
4.6 overall scores
Standard Deviation 12.89
|
6.7 overall scores
Standard Deviation 13.24
|
8.5 overall scores
Standard Deviation 12.99
|
|
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Composite Score
Week 76 (n = 133,138,143)
|
6.7 overall scores
Standard Deviation 13.21
|
5.8 overall scores
Standard Deviation 14.50
|
7.1 overall scores
Standard Deviation 12.49
|
|
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Composite Score
Week 100 (n=140,141,142)
|
6.6 overall scores
Standard Deviation 15.16
|
6.5 overall scores
Standard Deviation 14.41
|
6.2 overall scores
Standard Deviation 13.16
|
SECONDARY outcome
Timeframe: Baseline, Weeks 28, 52, 76, 100Population: FAS - Observed
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=165 Participants
Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Brolucizumab 6 mg
n=173 Participants
Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Aflibercept 2 mg
n=168 Participants
Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks
|
|---|---|---|---|
|
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - General Vision
Week 28
|
7.8 overall scores
Standard Deviation 14.75
|
10.8 overall scores
Standard Deviation 18.11
|
11.3 overall scores
Standard Deviation 15.88
|
|
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - General Vision
Week 52 (n = 151,148,157)
|
6.6 overall scores
Standard Deviation 14.74
|
11.2 overall scores
Standard Deviation 17.18
|
10.7 overall scores
Standard Deviation 17.62
|
|
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - General Vision
Week 76 (n = 133,138,143)
|
7.5 overall scores
Standard Deviation 14.89
|
10.0 overall scores
Standard Deviation 17.80
|
11.7 overall scores
Standard Deviation 17.97
|
|
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - General Vision
Week 100 (n=140,141,142)
|
10.4 overall scores
Standard Deviation 17.87
|
13.5 overall scores
Standard Deviation 17.97
|
11.5 overall scores
Standard Deviation 16.21
|
SECONDARY outcome
Timeframe: Baseline, Weeks 28, 52, 76, 100Population: FAS - Observed
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=165 Participants
Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Brolucizumab 6 mg
n=173 Participants
Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Aflibercept 2 mg
n=168 Participants
Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks
|
|---|---|---|---|
|
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Ocular Pain
Week 100 (n=140,141,142)
|
3.1 overall scores
Standard Deviation 19.90
|
3.1 overall scores
Standard Deviation 18.37
|
2.0 overall scores
Standard Deviation 19.73
|
|
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Ocular Pain
Week 28
|
2.2 overall scores
Standard Deviation 21.02
|
2.4 overall scores
Standard Deviation 21.92
|
4.3 overall scores
Standard Deviation 23.61
|
|
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Ocular Pain
Week 52 (n = 151,148,157)
|
1.0 overall scores
Standard Deviation 19.55
|
4.9 overall scores
Standard Deviation 19.54
|
5.3 overall scores
Standard Deviation 22.16
|
|
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Ocular Pain
Week 76 (n = 133,138,143)
|
4.1 overall scores
Standard Deviation 19.75
|
2.1 overall scores
Standard Deviation 22.78
|
3.9 overall scores
Standard Deviation 21.72
|
SECONDARY outcome
Timeframe: Baseline, Weeks 28, 52, 76, 100Population: FAS - Observed
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=165 Participants
Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Brolucizumab 6 mg
n=173 Participants
Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Aflibercept 2 mg
n=168 Participants
Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks
|
|---|---|---|---|
|
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Near Activities
Week 28
|
8.4 overall scores
Standard Deviation 19.83
|
13.2 overall scores
Standard Deviation 24.93
|
13.7 overall scores
Standard Deviation 20.51
|
|
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Near Activities
Week 52 (n = 151,148,157)
|
8.1 overall scores
Standard Deviation 21.41
|
14.1 overall scores
Standard Deviation 24.17
|
13.4 overall scores
Standard Deviation 23.64
|
|
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Near Activities
Week 76 (n = 133,138,143)
|
11.7 overall scores
Standard Deviation 20.00
|
14.9 overall scores
Standard Deviation 23.35
|
12.4 overall scores
Standard Deviation 20.92
|
|
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Near Activities
Week 100 (n=140,141,142)
|
11.6 overall scores
Standard Deviation 22.23
|
15.7 overall scores
Standard Deviation 22.01
|
10.4 overall scores
Standard Deviation 23.50
|
SECONDARY outcome
Timeframe: Baseline, Weeks 28, 52, 76, 100Population: FAS - Observed
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=165 Participants
Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Brolucizumab 6 mg
n=173 Participants
Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Aflibercept 2 mg
n=168 Participants
Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks
|
|---|---|---|---|
|
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Distance Activities
Week 28
|
6.0 overall scores
Standard Deviation 18.39
|
7.9 overall scores
Standard Deviation 21.58
|
9.0 overall scores
Standard Deviation 19.35
|
|
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Distance Activities
Week 52 (n = 151,148,157)
|
4.2 overall scores
Standard Deviation 22.20
|
9.0 overall scores
Standard Deviation 19.42
|
9.9 overall scores
Standard Deviation 20.05
|
|
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Distance Activities
Week 76 (n = 133,138,143)
|
8.3 overall scores
Standard Deviation 20.45
|
8.1 overall scores
Standard Deviation 19.20
|
7.0 overall scores
Standard Deviation 18.39
|
|
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Distance Activities
Week 100 (n=140,141,142)
|
6.4 overall scores
Standard Deviation 20.68
|
7.0 overall scores
Standard Deviation 19.24
|
6.7 overall scores
Standard Deviation 19.15
|
SECONDARY outcome
Timeframe: Baseline, Weeks 28, 52, 76, 100Population: FAS - Observed
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=165 Participants
Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Brolucizumab 6 mg
n=173 Participants
Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Aflibercept 2 mg
n=168 Participants
Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks
|
|---|---|---|---|
|
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Social Functioning
Week 28
|
2.7 overall scores
Standard Deviation 17.79
|
2.2 overall scores
Standard Deviation 18.00
|
3.9 overall scores
Standard Deviation 14.15
|
|
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Social Functioning
Week 52 (n = 151,148,157)
|
3.1 overall scores
Standard Deviation 18.82
|
2.7 overall scores
Standard Deviation 17.53
|
3.8 overall scores
Standard Deviation 15.98
|
|
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Social Functioning
Week 76 (n = 133,138,143)
|
3.6 overall scores
Standard Deviation 17.24
|
0.5 overall scores
Standard Deviation 18.95
|
1.7 overall scores
Standard Deviation 16.49
|
|
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Social Functioning
Week 100 (n=140,141,142)
|
2.5 overall scores
Standard Deviation 19.68
|
2.0 overall scores
Standard Deviation 21.82
|
1.4 overall scores
Standard Deviation 16.38
|
SECONDARY outcome
Timeframe: Baseline, Weeks 28, 52, 76, 100Population: FAS - Observed
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=165 Participants
Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Brolucizumab 6 mg
n=173 Participants
Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Aflibercept 2 mg
n=168 Participants
Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks
|
|---|---|---|---|
|
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Mental Health
Week 28
|
7.8 overall scores
Standard Deviation 20.63
|
8.2 overall scores
Standard Deviation 22.21
|
8.7 overall scores
Standard Deviation 19.71
|
|
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Mental Health
Week 52 (n = 151,148,157)
|
7.9 overall scores
Standard Deviation 22.93
|
9.6 overall scores
Standard Deviation 21.42
|
11.3 overall scores
Standard Deviation 21.34
|
|
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Mental Health
Week 76 (n = 133,138,143)
|
10.3 overall scores
Standard Deviation 21.07
|
11.5 overall scores
Standard Deviation 21.10
|
11.2 overall scores
Standard Deviation 20.93
|
|
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Mental Health
Week 100 (n=140,141,142)
|
11.7 overall scores
Standard Deviation 25.28
|
9.4 overall scores
Standard Deviation 23.62
|
10.9 overall scores
Standard Deviation 22.22
|
SECONDARY outcome
Timeframe: Baseline, Weeks 28, 52, 76, 100Population: FAS - Observed
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=165 Participants
Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Brolucizumab 6 mg
n=173 Participants
Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Aflibercept 2 mg
n=168 Participants
Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks
|
|---|---|---|---|
|
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Role Difficulties
Week 28
|
8.0 overall scores
Standard Deviation 24.93
|
6.5 overall scores
Standard Deviation 26.81
|
9.4 overall scores
Standard Deviation 27.34
|
|
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Role Difficulties
Week 52 (n = 151,148,157)
|
6.9 overall scores
Standard Deviation 23.88
|
6.1 overall scores
Standard Deviation 29.11
|
11.3 overall scores
Standard Deviation 25.47
|
|
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Role Difficulties
Week 76 (n = 133,138,143)
|
9.9 overall scores
Standard Deviation 25.10
|
6.8 overall scores
Standard Deviation 29.48
|
7.4 overall scores
Standard Deviation 27.76
|
|
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Role Difficulties
Week 100 (n=140,141,142)
|
9.3 overall scores
Standard Deviation 28.27
|
9.6 overall scores
Standard Deviation 28.88
|
6.9 overall scores
Standard Deviation 26.19
|
SECONDARY outcome
Timeframe: Baseline, Weeks 28, 52, 76, 100Population: FAS - Observed
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=165 Participants
Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Brolucizumab 6 mg
n=173 Participants
Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Aflibercept 2 mg
n=168 Participants
Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks
|
|---|---|---|---|
|
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Dependency
Week 28
|
6.3 overall scores
Standard Deviation 21.80
|
6.1 overall scores
Standard Deviation 25.16
|
7.1 overall scores
Standard Deviation 22.06
|
|
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Dependency
Week 52 (n = 151,148,157)
|
3.8 overall scores
Standard Deviation 23.05
|
4.1 overall scores
Standard Deviation 25.36
|
9.0 overall scores
Standard Deviation 22.68
|
|
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Dependency
Week 76 (n = 133,138,143)
|
5.2 overall scores
Standard Deviation 22.93
|
4.2 overall scores
Standard Deviation 25.56
|
6.8 overall scores
Standard Deviation 22.59
|
|
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Dependency
Week 100 (n=140,141,142)
|
5.5 overall scores
Standard Deviation 24.89
|
3.2 overall scores
Standard Deviation 25.79
|
5.6 overall scores
Standard Deviation 25.35
|
SECONDARY outcome
Timeframe: Baseline, Weeks 28, 52, 76, 100Population: FAS - Observed
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=108 Participants
Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Brolucizumab 6 mg
n=107 Participants
Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Aflibercept 2 mg
n=100 Participants
Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks
|
|---|---|---|---|
|
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Driving
Week 28
|
4.7 overall scores
Standard Deviation 16.40
|
1.9 overall scores
Standard Deviation 17.74
|
6.7 overall scores
Standard Deviation 15.06
|
|
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Driving
Week 52 (n = 97,98,91)
|
5.2 overall scores
Standard Deviation 16.51
|
3.6 overall scores
Standard Deviation 18.73
|
6.4 overall scores
Standard Deviation 17.64
|
|
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Driving
Week 76 (n = 86,86,83)
|
5.5 overall scores
Standard Deviation 16.09
|
2.9 overall scores
Standard Deviation 18.34
|
6.5 overall scores
Standard Deviation 19.13
|
|
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Driving
Week 100 (n=86,86,81)
|
6.2 overall scores
Standard Deviation 16.58
|
4.3 overall scores
Standard Deviation 20.24
|
2.3 overall scores
Standard Deviation 18.84
|
SECONDARY outcome
Timeframe: Baseline, Weeks 28, 52, 76, 100Population: FAS - Observed
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=162 Participants
Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Brolucizumab 6 mg
n=171 Participants
Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Aflibercept 2 mg
n=165 Participants
Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks
|
|---|---|---|---|
|
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Color Vision
Week 28
|
2.6 overall scores
Standard Deviation 14.37
|
2.6 overall scores
Standard Deviation 18.20
|
1.8 overall scores
Standard Deviation 14.49
|
|
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Color Vision
Week 52 (n = 148,147,152)
|
2.0 overall scores
Standard Deviation 16.11
|
2.0 overall scores
Standard Deviation 12.59
|
1.6 overall scores
Standard Deviation 15.13
|
|
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Color Vision
Week 76 (n = 131,137,140)
|
1.7 overall scores
Standard Deviation 13.58
|
0.2 overall scores
Standard Deviation 17.01
|
0.2 overall scores
Standard Deviation 13.90
|
|
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Color Vision
Week 100 (n=139,138,138)
|
2.0 overall scores
Standard Deviation 14.14
|
1.3 overall scores
Standard Deviation 15.79
|
0.5 overall scores
Standard Deviation 16.94
|
SECONDARY outcome
Timeframe: Baseline, Weeks 28, 52, 76, 100Population: FAS - Observed
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=165 Participants
Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Brolucizumab 6 mg
n=171 Participants
Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Aflibercept 2 mg
n=168 Participants
Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks
|
|---|---|---|---|
|
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Peripheral Vision
Week 28
|
3.6 overall scores
Standard Deviation 20.89
|
1.6 overall scores
Standard Deviation 22.05
|
9.2 overall scores
Standard Deviation 22.82
|
|
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Peripheral Vision
Week 52 (n = 151,148,156)
|
1.3 overall scores
Standard Deviation 22.51
|
4.1 overall scores
Standard Deviation 22.97
|
8.5 overall scores
Standard Deviation 22.98
|
|
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Peripheral Vision
Week 76 (n = 133, 138, 143)
|
5.6 overall scores
Standard Deviation 21.01
|
1.1 overall scores
Standard Deviation 24.33
|
7.3 overall scores
Standard Deviation 20.94
|
|
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Peripheral Vision
Week 100 (n=140, 140, 142)
|
3.4 overall scores
Standard Deviation 21.87
|
-0.4 overall scores
Standard Deviation 24.36
|
6.3 overall scores
Standard Deviation 24.81
|
SECONDARY outcome
Timeframe: Baseline, Weeks 28, 52, 76, 100Population: FAS - Observed
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=165 Participants
Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Brolucizumab 6 mg
n=173 Participants
Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Aflibercept 2 mg
n=168 Participants
Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks
|
|---|---|---|---|
|
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - General Health Rating
Week 28
|
0.9 overall scores
Standard Deviation 19.50
|
3.0 overall scores
Standard Deviation 22.10
|
6.1 overall scores
Standard Deviation 19.25
|
|
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - General Health Rating
Week 52 (n = 151,148,157)
|
4.3 overall scores
Standard Deviation 22.50
|
6.8 overall scores
Standard Deviation 22.32
|
6.8 overall scores
Standard Deviation 24.94
|
|
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - General Health Rating
Week 76 (n = 133, 138, 143)
|
2.3 overall scores
Standard Deviation 23.53
|
6.3 overall scores
Standard Deviation 24.18
|
8.2 overall scores
Standard Deviation 20.93
|
|
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - General Health Rating
Week 100 (n=140, 141, 142)
|
2.3 overall scores
Standard Deviation 23.97
|
6.9 overall scores
Standard Deviation 23.55
|
8.8 overall scores
Standard Deviation 21.72
|
SECONDARY outcome
Timeframe: Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.Population: Safety Set
Outcome measures
| Measure |
Brolucizumab 3 mg
n=190 Participants
Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Brolucizumab 6 mg
n=189 Participants
Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Aflibercept 2 mg
n=187 Participants
Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks
|
|---|---|---|---|
|
Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye
Number of subjects with at least one AE
|
103 Participants
|
92 Participants
|
94 Participants
|
|
Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye
Cataract
|
17 Participants
|
16 Participants
|
13 Participants
|
|
Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye
Conjunctival haemorrhage
|
19 Participants
|
16 Participants
|
19 Participants
|
|
Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye
Vitreous floaters
|
7 Participants
|
10 Participants
|
6 Participants
|
|
Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye
Diabetic retinal oedema
|
12 Participants
|
9 Participants
|
4 Participants
|
|
Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye
Conjunctivitis
|
4 Participants
|
6 Participants
|
1 Participants
|
|
Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye
Uveitis
|
4 Participants
|
2 Participants
|
0 Participants
|
|
Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye
Corneal abrasion
|
3 Participants
|
1 Participants
|
4 Participants
|
|
Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye
Retinal exudates
|
7 Participants
|
1 Participants
|
3 Participants
|
|
Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye
Intraocular pressure increased
|
14 Participants
|
11 Participants
|
3 Participants
|
|
Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye
Vitreous detachment
|
9 Participants
|
10 Participants
|
3 Participants
|
|
Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye
Dry eye
|
10 Participants
|
6 Participants
|
5 Participants
|
|
Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye
Eye pain
|
3 Participants
|
6 Participants
|
5 Participants
|
|
Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye
Posterior capsule opacification
|
3 Participants
|
6 Participants
|
3 Participants
|
|
Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye
Eye irritation
|
3 Participants
|
5 Participants
|
4 Participants
|
|
Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye
Blepharitis
|
3 Participants
|
4 Participants
|
4 Participants
|
|
Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye
Keratitis
|
0 Participants
|
4 Participants
|
3 Participants
|
|
Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye
Vitreous haemorrhage
|
2 Participants
|
4 Participants
|
3 Participants
|
|
Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye
Punctate keratitis
|
8 Participants
|
3 Participants
|
1 Participants
|
|
Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye
Vision blurred
|
6 Participants
|
3 Participants
|
1 Participants
|
|
Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye
Visual acuity reduced
|
7 Participants
|
3 Participants
|
9 Participants
|
|
Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye
Iridocyclitis
|
4 Participants
|
2 Participants
|
0 Participants
|
|
Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye
Ocular hypertension
|
4 Participants
|
2 Participants
|
2 Participants
|
|
Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye
Cataract subcapsular
|
1 Participants
|
0 Participants
|
4 Participants
|
|
Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye
Conjunctival hyperaemia
|
4 Participants
|
0 Participants
|
1 Participants
|
|
Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye
Vitreoretinal traction syndrome
|
1 Participants
|
0 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.Population: Safety Set
Outcome measures
| Measure |
Brolucizumab 3 mg
n=190 Participants
Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Brolucizumab 6 mg
n=189 Participants
Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
|
Aflibercept 2 mg
n=187 Participants
Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks
|
|---|---|---|---|
|
Number of Subjects With Non-ocular Adverse Events (AEs) (>=2% in Any Treatment Arm)
|
146 Participants
|
146 Participants
|
143 Participants
|
Adverse Events
Brolucizumab 3mg
Serious events: 58 serious events
Other events: 146 other events
Deaths: 4 deaths
Brolucizumab 6mg
Serious events: 59 serious events
Other events: 148 other events
Deaths: 8 deaths
Aflibercept 2mg
Serious events: 63 serious events
Other events: 137 other events
Deaths: 7 deaths
Overall
Serious events: 180 serious events
Other events: 431 other events
Deaths: 19 deaths
Serious adverse events
| Measure |
Brolucizumab 3mg
n=190 participants at risk
Brolucizumab 3mg
|
Brolucizumab 6mg
n=189 participants at risk
Brolucizumab 6mg
|
Aflibercept 2mg
n=187 participants at risk
Aflibercept 2mg
|
Overall
n=566 participants at risk
Overall
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Cardiac disorders
Acute left ventricular failure
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.1%
2/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
3/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Cardiac disorders
Angina pectoris
|
1.1%
2/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
3/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Cardiac disorders
Arrhythmia
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.1%
2/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
3/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Cardiac disorders
Atrioventricular block
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Cardiac disorders
Cardiac arrest
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.35%
2/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Cardiac disorders
Cardiac failure
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.1%
2/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.71%
4/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Cardiac disorders
Cardiac failure congestive
|
2.6%
5/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.1%
2/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.7%
5/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.1%
12/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Cardiac disorders
Cardiorenal syndrome
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Cardiac disorders
Cardiovascular disorder
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Cardiac disorders
Coronary artery disease
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.1%
2/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.6%
3/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.1%
6/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Cardiac disorders
Mitral valve disease mixed
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Cardiac disorders
Myocardial infarction
|
1.1%
2/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.6%
3/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.6%
3/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.4%
8/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Endocrine disorders
Goitre
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Eye disorders
Amaurosis fugax - Fellow eye
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Eye disorders
Cataract - Fellow eye
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.6%
3/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.1%
4/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.2%
7/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Eye disorders
Cataract - Study eye
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.6%
5/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.6%
3/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.6%
9/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Eye disorders
Conjunctival cyst - Study eye
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Eye disorders
Diabetic retinal oedema - Study eye
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Eye disorders
Diabetic retinopathy - Fellow eye
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Eye disorders
Epiretinal membrane - Study eye
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Eye disorders
Glaucoma - Fellow eye
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Eye disorders
Glaucoma - Study eye
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Eye disorders
Macular oedema - Study eye
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Eye disorders
Posterior capsule opacification - Study eye
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Eye disorders
Pterygium - Study eye
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Eye disorders
Retinal artery occlusion - Fellow eye
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Eye disorders
Retinal artery occlusion - Study eye
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.35%
2/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Eye disorders
Retinal detachment - Study eye
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.35%
2/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Eye disorders
Retinal occlusive vasculitis - Study eye
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Eye disorders
Retinal vasculitis - Study eye
|
1.1%
2/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.35%
2/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Eye disorders
Retinal vein thrombosis - Study eye
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Eye disorders
Uveitis - Study eye
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Eye disorders
Visual acuity reduced - Study eye
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Eye disorders
Vitreous floaters - Study eye
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Eye disorders
Vitreous haemorrhage - Fellow eye
|
1.1%
2/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
3/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Eye disorders
Vitritis - Study eye
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Gastrointestinal disorders
Gastric polyps
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Gastrointestinal disorders
Haematemesis
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Gastrointestinal disorders
Mesenteric vein thrombosis
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Gastrointestinal disorders
Proctitis ulcerative
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Gastrointestinal disorders
Rectal polyp
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Gastrointestinal disorders
Ulcerative gastritis
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
General disorders
Death
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
General disorders
Generalised oedema
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.1%
2/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.35%
2/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
General disorders
Oedema peripheral
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
General disorders
Pyrexia
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.35%
2/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
General disorders
Sudden death
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.35%
2/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.1%
2/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.35%
2/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Hepatobiliary disorders
Gallbladder disorder
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Infections and infestations
Appendicitis
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.35%
2/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Infections and infestations
Bacteraemia
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Infections and infestations
COVID-19
|
1.1%
2/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.6%
3/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.1%
2/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.2%
7/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.35%
2/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Infections and infestations
Cellulitis
|
1.1%
2/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.1%
2/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.88%
5/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Infections and infestations
Diabetic foot infection
|
1.1%
2/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
3/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Infections and infestations
Encephalitis
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Infections and infestations
Endophthalmitis - Study eye
|
1.1%
2/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
3/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Infections and infestations
Fungal sepsis
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Infections and infestations
Gas gangrene
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Infections and infestations
Localised infection
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Infections and infestations
Osteomyelitis
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.1%
2/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.6%
3/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.1%
6/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Infections and infestations
Osteomyelitis acute
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Infections and infestations
Periodontitis
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Infections and infestations
Pneumonia
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.1%
2/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.71%
4/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Infections and infestations
Pneumonia fungal
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Infections and infestations
Postoperative abscess
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Infections and infestations
Pulmonary sepsis
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Infections and infestations
Sepsis
|
1.1%
2/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.1%
2/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.71%
4/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Infections and infestations
Septic shock
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.35%
2/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Infections and infestations
Wound infection
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Injury, poisoning and procedural complications
Cataract operation complication - Fellow eye
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.1%
2/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.35%
2/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Injury, poisoning and procedural complications
Laryngeal injury
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.1%
2/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.35%
2/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Injury, poisoning and procedural complications
Peripheral artery restenosis
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Injury, poisoning and procedural complications
Skin flap necrosis
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Investigations
Hepatitis C antibody positive
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Investigations
International normalised ratio increased
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Investigations
Intraocular pressure increased - Study eye
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.6%
3/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
3/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Metabolism and nutrition disorders
Diabetic metabolic decompensation
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.1%
2/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
3/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.35%
2/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.1%
2/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.35%
2/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Metabolism and nutrition disorders
Ketoacidosis
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.1%
2/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.35%
2/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer metastatic
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.1%
2/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.35%
2/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Nervous system disorders
Carotid artery occlusion
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.1%
2/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.35%
2/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Nervous system disorders
Cerebral atrophy
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.35%
2/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.6%
3/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.1%
4/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.1%
4/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.9%
11/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Nervous system disorders
Lacunar stroke
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Nervous system disorders
Migraine
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Nervous system disorders
Optic neuritis - Study eye
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Nervous system disorders
Syncope
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Pregnancy, puerperium and perinatal conditions
Pre-eclampsia
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.1%
2/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.1%
2/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.88%
5/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Renal and urinary disorders
Bladder pain
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.35%
2/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
3/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Renal and urinary disorders
End stage renal disease
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Renal and urinary disorders
Nephropathy
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Renal and urinary disorders
Renal failure
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.1%
4/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.1%
6/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Renal and urinary disorders
Urinary bladder rupture
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Reproductive system and breast disorders
Prostatic disorder
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.1%
2/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
3/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.35%
2/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.1%
2/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.71%
4/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.1%
2/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
3/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.1%
2/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
3/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Vascular disorders
Accelerated hypertension
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Vascular disorders
Dry gangrene
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Vascular disorders
Embolism venous
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Vascular disorders
Extremity necrosis
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Vascular disorders
Haematoma
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Vascular disorders
Hypertension
|
1.1%
2/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.35%
2/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.1%
2/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
3/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Vascular disorders
Hypertensive emergency
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Vascular disorders
Hypertensive urgency
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.1%
2/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.35%
2/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Vascular disorders
Hypotension
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.35%
2/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.1%
2/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.35%
2/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.18%
1/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
Other adverse events
| Measure |
Brolucizumab 3mg
n=190 participants at risk
Brolucizumab 3mg
|
Brolucizumab 6mg
n=189 participants at risk
Brolucizumab 6mg
|
Aflibercept 2mg
n=187 participants at risk
Aflibercept 2mg
|
Overall
n=566 participants at risk
Overall
|
|---|---|---|---|---|
|
Eye disorders
Vitreoretinal traction syndrome - Study eye
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.7%
5/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.1%
6/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Blood and lymphatic system disorders
Anaemia
|
3.2%
6/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
4.8%
9/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
4.8%
9/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
4.2%
24/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Cardiac disorders
Atrial fibrillation
|
4.2%
8/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.8%
10/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Cardiac disorders
Cardiac failure congestive
|
1.1%
2/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.1%
4/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.6%
3/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.6%
9/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Ear and labyrinth disorders
Vertigo
|
1.1%
2/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.6%
3/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.7%
5/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.8%
10/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Eye disorders
Blepharitis - Fellow eye
|
2.1%
4/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.6%
5/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.1%
4/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.3%
13/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Eye disorders
Ocular hypertension - Fellow eye
|
1.1%
2/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.6%
5/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.1%
2/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.6%
9/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Eye disorders
Ocular hypertension - Study eye
|
2.1%
4/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.1%
2/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.1%
2/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.4%
8/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Eye disorders
Blepharitis - Study eye
|
1.6%
3/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.1%
4/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.1%
4/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.9%
11/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Eye disorders
Cataract - Fellow eye
|
5.8%
11/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
6.3%
12/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.7%
5/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
4.9%
28/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Eye disorders
Cataract - Study eye
|
8.9%
17/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
6.3%
12/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
5.3%
10/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
6.9%
39/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Eye disorders
Cataract subcapsular - Study eye
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.1%
4/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.88%
5/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Eye disorders
Conjunctival haemorrhage - Fellow eye
|
1.1%
2/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.6%
5/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
3.7%
7/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.5%
14/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Eye disorders
Conjunctival haemorrhage - Study eye
|
10.0%
19/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
8.5%
16/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
10.2%
19/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
9.5%
54/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Eye disorders
Conjunctival hyperaemia - Study eye
|
2.1%
4/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.88%
5/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Eye disorders
Conjunctivitis allergic - Fellow eye
|
1.6%
3/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.1%
2/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.1%
4/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.6%
9/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Eye disorders
Diabetic retinal oedema - Fellow eye
|
8.9%
17/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
6.3%
12/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
6.4%
12/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
7.2%
41/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Eye disorders
Diabetic retinal oedema - Study eye
|
6.3%
12/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
4.8%
9/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.1%
4/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
4.4%
25/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Eye disorders
Diabetic retinopathy - Fellow eye
|
3.2%
6/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
3.2%
6/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
4.3%
8/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
3.5%
20/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Eye disorders
Dry eye - Fellow eye
|
4.7%
9/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.6%
5/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.7%
5/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
3.4%
19/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Eye disorders
Dry eye - Study eye
|
5.8%
11/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
3.2%
6/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.7%
5/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
3.9%
22/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Eye disorders
Eye irritation - Fellow eye
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
3.2%
6/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.1%
2/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.4%
8/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Eye disorders
Eye irritation - Study eye
|
1.6%
3/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.6%
5/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.1%
4/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.1%
12/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Eye disorders
Eye pain - Fellow eye
|
1.1%
2/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.1%
2/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.1%
4/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.4%
8/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Eye disorders
Eye pain - Study eye
|
1.6%
3/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
3.2%
6/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.7%
5/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.5%
14/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Eye disorders
Iridocyclitis - Study eye
|
2.1%
4/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.1%
2/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.1%
6/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Eye disorders
Keratitis - Study eye
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.1%
4/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.6%
3/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.2%
7/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Eye disorders
Macular oedema - Fellow eye
|
2.6%
5/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
3.2%
6/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.1%
2/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.3%
13/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Eye disorders
Posterior capsule opacification - Study eye
|
1.6%
3/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.6%
5/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.6%
3/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.9%
11/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Eye disorders
Punctate keratitis - Study eye
|
4.2%
8/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.6%
3/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.1%
12/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Eye disorders
Retinal exudates - Fellow eye
|
2.6%
5/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.6%
3/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.6%
3/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.9%
11/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Eye disorders
Visual acuity reduced - Study eye
|
3.7%
7/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.6%
3/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
4.3%
8/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
3.2%
18/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Eye disorders
Retinal exudates - Study eye
|
3.7%
7/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.6%
3/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.9%
11/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Eye disorders
Retinal haemorrhage - Fellow eye
|
2.6%
5/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.1%
2/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.4%
8/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Eye disorders
Retinal haemorrhage - Study eye
|
2.1%
4/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.1%
2/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.1%
6/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Eye disorders
Vision blurred - Study eye
|
3.2%
6/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.6%
3/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.8%
10/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Eye disorders
Visual acuity reduced - Fellow eye
|
2.1%
4/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.6%
3/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.6%
3/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.8%
10/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Eye disorders
Vitreous detachment - Fellow eye
|
2.6%
5/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.6%
5/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.1%
4/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.5%
14/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Eye disorders
Vitreous detachment - Study eye
|
4.7%
9/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
5.3%
10/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.6%
3/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
3.9%
22/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Eye disorders
Vitreous floaters - Fellow eye
|
3.7%
7/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.6%
5/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.7%
5/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
3.0%
17/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Eye disorders
Vitreous floaters - Study eye
|
3.7%
7/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
5.3%
10/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
3.2%
6/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
4.1%
23/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Eye disorders
Vitreous haemorrhage - Fellow eye
|
2.1%
4/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.1%
4/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.7%
5/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.3%
13/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Eye disorders
Vitreous haemorrhage - Study eye
|
1.1%
2/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.1%
4/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.6%
3/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.6%
9/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Gastrointestinal disorders
Constipation
|
2.1%
4/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.1%
4/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.7%
5/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.3%
13/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.6%
5/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
5.3%
10/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
3.2%
6/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
3.7%
21/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Gastrointestinal disorders
Nausea
|
1.1%
2/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.6%
5/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.6%
3/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.8%
10/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
2.6%
5/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
3.7%
7/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.1%
2/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.5%
14/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
General disorders
Oedema peripheral
|
2.1%
4/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.6%
5/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.7%
5/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.5%
14/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
General disorders
Pyrexia
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
4.2%
8/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.6%
3/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.1%
12/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Immune system disorders
Seasonal allergy
|
1.1%
2/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.1%
4/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.1%
4/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.8%
10/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Infections and infestations
Bronchitis
|
2.6%
5/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.6%
5/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.1%
4/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.5%
14/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Infections and infestations
COVID-19
|
4.2%
8/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
3.7%
7/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
3.7%
7/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
3.9%
22/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.1%
2/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.1%
4/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.1%
6/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Infections and infestations
Conjunctivitis - Fellow eye
|
1.6%
3/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
3.2%
6/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.1%
4/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.3%
13/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Infections and infestations
Conjunctivitis - Study eye
|
2.1%
4/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
3.2%
6/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.9%
11/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Infections and infestations
Ear infection
|
2.1%
4/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.1%
2/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.1%
6/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Infections and infestations
Herpes zoster
|
2.6%
5/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.88%
5/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Infections and infestations
Influenza
|
3.2%
6/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
4.2%
8/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
3.7%
7/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
3.7%
21/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Infections and infestations
Lower respiratory tract infection
|
2.1%
4/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.88%
5/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Infections and infestations
Nasopharyngitis
|
10.5%
20/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
9.5%
18/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
8.6%
16/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
9.5%
54/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Infections and infestations
Pneumonia
|
1.6%
3/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.1%
4/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.1%
4/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.9%
11/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Infections and infestations
Sinusitis
|
2.1%
4/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.6%
5/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.1%
4/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.3%
13/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Infections and infestations
Tooth infection
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.1%
4/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.88%
5/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.2%
6/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.6%
5/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.7%
5/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.8%
16/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Infections and infestations
Urinary tract infection
|
8.9%
17/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
10.6%
20/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
4.3%
8/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
8.0%
45/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Injury, poisoning and procedural complications
Corneal abrasion - Study eye
|
1.6%
3/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.1%
4/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.4%
8/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Injury, poisoning and procedural complications
Fall
|
2.6%
5/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.6%
5/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.1%
2/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.1%
12/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Injury, poisoning and procedural complications
Limb injury
|
2.1%
4/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.1%
6/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Investigations
Blood glucose increased
|
1.1%
2/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.1%
4/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.2%
7/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Investigations
Blood pressure increased
|
3.2%
6/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.1%
4/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.6%
3/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.3%
13/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Investigations
Glucose urine present
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.1%
4/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.1%
2/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.2%
7/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Investigations
Glycosylated haemoglobin increased
|
2.1%
4/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.1%
4/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.6%
9/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Investigations
Intraocular pressure increased - Fellow eye
|
2.6%
5/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.6%
3/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.4%
8/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Investigations
Intraocular pressure increased - Study eye
|
7.4%
14/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
5.8%
11/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.6%
3/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
4.9%
28/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.1%
2/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
3.2%
6/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.4%
8/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
3.7%
7/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.1%
4/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
3.7%
7/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
3.2%
18/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
2.1%
4/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.6%
3/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.6%
3/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.8%
10/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
1.1%
2/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.1%
4/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.1%
2/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.4%
8/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.1%
2/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.1%
4/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.53%
1/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.2%
7/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
1.6%
3/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
3.2%
6/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.6%
3/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.1%
12/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.3%
12/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
3.2%
6/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.7%
5/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
4.1%
23/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.1%
4/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.6%
5/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
3.2%
6/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.7%
15/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.1%
4/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
0.00%
0/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.1%
2/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.1%
6/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Nervous system disorders
Dizziness
|
2.6%
5/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.1%
4/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.6%
3/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.1%
12/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Nervous system disorders
Headache
|
1.6%
3/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
5.3%
10/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.6%
3/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.8%
16/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Nervous system disorders
Migraine
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.1%
2/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.7%
5/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.4%
8/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Psychiatric disorders
Depression
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.1%
4/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.6%
3/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.2%
7/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.1%
4/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.6%
3/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.4%
8/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.53%
1/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
3.7%
7/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
3.7%
7/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.7%
15/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Renal and urinary disorders
Renal failure
|
2.6%
5/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.1%
2/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.6%
3/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.8%
10/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.7%
7/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
5.8%
11/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
5.3%
10/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
4.9%
28/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
3.2%
6/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.1%
2/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.4%
8/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
2.1%
4/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
2.1%
4/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.1%
2/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
1.8%
10/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
|
Vascular disorders
Hypertension
|
11.6%
22/190 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
11.1%
21/189 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
12.8%
24/187 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
11.8%
67/566 • Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER