Trial Outcomes & Findings for Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Patients With Visual Impairment Due to Macular Edema Secondary to Branch Retinal Vein Occlusion (NCT NCT03802630)

NCT ID: NCT03802630

Last Updated: 2023-01-30

Results Overview

BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance of 4 meters. Min and max possible scores are 0-100 letters read respectively. A higher score represents better visual functioning. Missing and censored BCVA values were imputed by Last observation carried forward (LOCF) as the primary approach. Observed values from both scheduled and unscheduled post-baseline visits were used for the LOCF imputation. For subjects with no post-baseline BCVA value, the baseline value was carried forward.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 450 participants
• Primary outcome timeframe: Baseline, Week 24
• Results posted on: 2023-01-30

Participant Flow

Participants were recruited from 103 sites in 18 countries

The study comprised a screening period of 28 days

Participant milestones

Measure	Brolucizumab 6 mg 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT)	Aflibercept 2 mg 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT)
Overall Study STARTED	226	224
Overall Study COMPLETED	73	76
Overall Study NOT COMPLETED	153	148

Reasons for withdrawal

Measure	Brolucizumab 6 mg 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT)	Aflibercept 2 mg 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT)
Overall Study Study terminated by sponsor	130	134
Overall Study Subject decision	16	9
Overall Study Adverse Event	3	1
Overall Study Lost to Follow-up	2	2
Overall Study Physician Decision	2	0
Overall Study Death	0	2

Baseline Characteristics

Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Patients With Visual Impairment Due to Macular Edema Secondary to Branch Retinal Vein Occlusion

Baseline characteristics by cohort

Measure	Brolucizumab 6 mg n=226 Participants 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT)	Aflibercept 2 mg n=224 Participants 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT)	Total n=450 Participants Total of all reporting groups
Age, Continuous	65.4 Years STANDARD_DEVIATION 11.05 • n=5 Participants	65.0 Years STANDARD_DEVIATION 10.92 • n=7 Participants	65.2 Years STANDARD_DEVIATION 10.97 • n=5 Participants
Sex: Female, Male Female	117 Participants n=5 Participants	125 Participants n=7 Participants	242 Participants n=5 Participants
Sex: Female, Male Male	109 Participants n=5 Participants	99 Participants n=7 Participants	208 Participants n=5 Participants
Race/Ethnicity, Customized White	154 Participants n=5 Participants	153 Participants n=7 Participants	307 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
Race/Ethnicity, Customized Asian	65 Participants n=5 Participants	67 Participants n=7 Participants	132 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 24

Population: Full Analysis Set (FAS) included all randomized subjects who received at least one Intravitreal injection of the study treatment.

BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance of 4 meters.

Min and max possible scores are 0-100 letters read respectively. A higher score represents better visual functioning.

Missing and censored BCVA values were imputed by Last observation carried forward (LOCF) as the primary approach. Observed values from both scheduled and unscheduled post-baseline visits were used for the LOCF imputation. For subjects with no post-baseline BCVA value, the baseline value was carried forward.

Outcome measures

Measure	Brolucizumab 6 mg n=226 Participants 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT)	Aflibercept 2 mg n=224 Participants 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT)
Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 24	13.1 Letters read Standard Error 0.71	15.0 Letters read Standard Error 0.71

SECONDARY outcome

Timeframe: Baseline, Week 40 to Week 52

Population: FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment. The number analyzed per row is the number of subjects from the FAS who had a valid assessment for both baseline and the corresponding post baseline period.

An average BCVA over week 40 to week 52 was calculated. BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance of 4 meters.

Min and max possible scores are 0-100 letters read respectively. A higher score represents better visual functioning.

Outcome measures

Measure	Brolucizumab 6 mg n=123 Participants 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT)	Aflibercept 2 mg n=132 Participants 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT)
Change From Baseline in BCVA Averaged Over Week 40 to Week 52	12.9 Letters read Standard Deviation 12.81	16.9 Letters read Standard Deviation 10.63

SECONDARY outcome

Timeframe: Baseline, Week 64 to Week 76

Population: FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment. The number analyzed per row is the number of subjects from the FAS who had a valid assessment for both baseline and the corresponding post baseline period.

An average BCVA over week 64 to week 76 was calculated. BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance of 4 meters.

Min and max possible scores are 0-100 letters read respectively. A higher score represents better visual functioning.

Outcome measures

Measure	Brolucizumab 6 mg n=110 Participants 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT)	Aflibercept 2 mg n=121 Participants 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT)
Change From Baseline in BCVA Averaged Over Week 64 to Week 76	13.7 Letters read Standard Deviation 13.33	17.9 Letters read Standard Deviation 10.65

SECONDARY outcome

Timeframe: Baseline and every 4 weeks from baseline up to Week 76

Population: FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment. The number analyzed per row is the number of subjects from the FAS who had a valid assessment for both baseline and the corresponding post baseline visit.

BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance of 4 meters.

Min and max possible scores are 0-100 letters read respectively. A higher score represents better visual functioning.

Outcome measures

Measure	Brolucizumab 6 mg n=226 Participants 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT)	Aflibercept 2 mg n=224 Participants 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT)
Change From Baseline in BCVA by Visit up to Week 76 Week 4	9.2 Letters read Standard Deviation 8.22	10.3 Letters read Standard Deviation 10.13
Change From Baseline in BCVA by Visit up to Week 76 Week 8	11.9 Letters read Standard Deviation 10.68	12.8 Letters read Standard Deviation 10.84
Change From Baseline in BCVA by Visit up to Week 76 Week 12	13.2 Letters read Standard Deviation 10.22	14.8 Letters read Standard Deviation 11.23
Change From Baseline in BCVA by Visit up to Week 76 Week 16	12.2 Letters read Standard Deviation 12.59	16.3 Letters read Standard Deviation 11.58
Change From Baseline in BCVA by Visit up to Week 76 Week 20	13.5 Letters read Standard Deviation 10.83	16.3 Letters read Standard Deviation 12.15
Change From Baseline in BCVA by Visit up to Week 76 Week 24	12.7 Letters read Standard Deviation 12.36	16.6 Letters read Standard Deviation 11.35
Change From Baseline in BCVA by Visit up to Week 76 Week 28	12.1 Letters read Standard Deviation 13.88	16.4 Letters read Standard Deviation 10.62
Change From Baseline in BCVA by Visit up to Week 76 Week 32	12.2 Letters read Standard Deviation 13.24	15.7 Letters read Standard Deviation 10.94
Change From Baseline in BCVA by Visit up to Week 76 Week 36	11.8 Letters read Standard Deviation 14.75	16.9 Letters read Standard Deviation 10.95
Change From Baseline in BCVA by Visit up to Week 76 Week 40	12.7 Letters read Standard Deviation 12.89	16.9 Letters read Standard Deviation 10.74
Change From Baseline in BCVA by Visit up to Week 76 Week 44	13.5 Letters read Standard Deviation 13.28	17.2 Letters read Standard Deviation 11.37
Change From Baseline in BCVA by Visit up to Week 76 Week 48	13.3 Letters read Standard Deviation 13.38	17.7 Letters read Standard Deviation 10.79
Change From Baseline in BCVA by Visit up to Week 76 Week 52	13.5 Letters read Standard Deviation 13.42	17.2 Letters read Standard Deviation 10.46
Change From Baseline in BCVA by Visit up to Week 76 Week 56	14.9 Letters read Standard Deviation 10.86	17.7 Letters read Standard Deviation 10.62
Change From Baseline in BCVA by Visit up to Week 76 Week 60	13.7 Letters read Standard Deviation 13.67	17.7 Letters read Standard Deviation 10.33
Change From Baseline in BCVA by Visit up to Week 76 Week 64	14.1 Letters read Standard Deviation 13.72	18.0 Letters read Standard Deviation 10.54
Change From Baseline in BCVA by Visit up to Week 76 Week 68	13.9 Letters read Standard Deviation 13.83	17.7 Letters read Standard Deviation 10.75
Change From Baseline in BCVA by Visit up to Week 76 Week 72	13.9 Letters read Standard Deviation 13.38	18.4 Letters read Standard Deviation 11.44
Change From Baseline in BCVA by Visit up to Week 76 Week 76	14.4 Letters read Standard Deviation 13.72	18.1 Letters read Standard Deviation 11.19

SECONDARY outcome

Timeframe: Baseline and every 4 weeks from baseline up to Week 76

Population: FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment. The number analyzed per row is the number of subjects from the FAS who had a valid assessment for both baseline and the corresponding post baseline visit.

The summary by visit was conducted based on the BCVA observed from each of the corresponding visits.

BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance of 4 meters.

Min and max possible scores are 0-100 letters read respectively. A higher score represents better visual functioning.

Every 5 letters represents 1 line of vision on the reading chart.

Outcome measures

Measure	Brolucizumab 6 mg n=226 Participants 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT)	Aflibercept 2 mg n=224 Participants 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT)
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 4; BCVA gain from baseline >=5	154 Participants	150 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 4; BCVA gain from baseline >=10	102 Participants	110 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 4; BCVA gain from baseline >=15	64 Participants	79 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 8; BCVA gain from baseline >=5	158 Participants	155 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 8; BCVA gain from baseline >=10	117 Participants	118 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 8; BCVA gain from baseline >=15	92 Participants	93 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 12; BCVA gain from baseline >=5	156 Participants	156 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 12; BCVA gain from baseline >=10	114 Participants	125 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 12; BCVA gain from baseline >=15	90 Participants	102 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 16; BCVA gain from baseline >=5	127 Participants	143 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 16; BCVA gain from baseline >=10	95 Participants	118 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 16; BCVA gain from baseline >=15	73 Participants	100 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 20; BCVA gain from baseline >=5	119 Participants	131 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 20; BCVA gain from baseline >=10	96 Participants	108 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 20; BCVA gain from baseline >=15	74 Participants	92 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 24; BCVA gain from baseline >=5	122 Participants	126 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 24; BCVA gain from baseline >=10	90 Participants	109 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 24; BCVA gain from baseline >=15	75 Participants	91 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 28; BCVA gain from baseline >=5	108 Participants	121 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 28; BCVA gain from baseline >=10	89 Participants	107 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 28; BCVA gain from baseline >=15	75 Participants	87 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 32; BCVA gain from baseline >=5	97 Participants	110 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 32; BCVA gain from baseline >=10	79 Participants	94 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 32; BCVA gain from baseline >=15	60 Participants	78 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 36; BCVA gain from baseline >=5	100 Participants	112 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 36; BCVA gain from baseline >=10	81 Participants	98 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 36; BCVA gain from baseline >=15	62 Participants	83 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 40; BCVA gain from baseline >=5	96 Participants	114 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 40; BCVA gain from baseline >=10	79 Participants	98 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 40; BCVA gain from baseline >=15	65 Participants	85 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 44; BCVA gain from baseline >=5	94 Participants	111 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 44; BCVA gain from baseline >=10	78 Participants	97 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 44; BCVA gain from baseline >=15	64 Participants	88 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 48; BCVA gain from baseline >=5	92 Participants	112 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 48; BCVA gain from baseline >=10	76 Participants	95 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 48; BCVA gain from baseline >=15	61 Participants	80 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 52; BCVA gain from baseline >=5	87 Participants	117 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 52; BCVA gain from baseline >=10	75 Participants	99 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 52; BCVA gain from baseline >=15	64 Participants	87 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 56; BCVA gain from baseline >=5	90 Participants	113 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 56; BCVA gain from baseline >=10	76 Participants	106 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 56; BCVA gain from baseline >=15	58 Participants	84 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 60; BCVA gain from baseline >=5	86 Participants	116 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 60; BCVA gain from baseline >=10	71 Participants	104 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 60; BCVA gain from baseline >=15	62 Participants	88 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 64; BCVA gain from baseline >=5	86 Participants	112 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 64; BCVA gain from baseline >=10	74 Participants	98 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 64; BCVA gain from baseline >=15	58 Participants	82 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 68; BCVA gain from baseline >=5	79 Participants	103 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 68; BCVA gain from baseline >=10	67 Participants	88 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 68; BCVA gain from baseline >=15	55 Participants	76 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 72; BCVA gain from baseline >=5	68 Participants	89 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 72; BCVA gain from baseline >=10	56 Participants	75 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 72; BCVA gain from baseline >=15	45 Participants	63 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 76; BCVA gain from baseline >=5	62 Participants	67 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 76; BCVA gain from baseline >=10	52 Participants	61 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 76; BCVA gain from baseline >=15	43 Participants	53 Participants

SECONDARY outcome

Timeframe: Baseline and every 4 weeks from baseline up to Week 76

Population: FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment. The number analyzed per row is the number of subjects from the FAS who had a valid assessment for both baseline and the corresponding post baseline visit.

The summary by visit was conducted based on the BCVA observed from each of the corresponding visit.

BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance of 4 meters.

Min and max possible scores are 0-100 letters read respectively. A higher score represents better visual functioning.

Every 5 letters represents 1 line of vision on the reading chart.

Outcome measures

Measure	Brolucizumab 6 mg n=226 Participants 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT)	Aflibercept 2 mg n=224 Participants 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT)
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 16; BCVA loss from baseline >=5	9 Participants	4 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 16; BCVA loss from baseline >=10	5 Participants	2 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 44; BCVA loss from baseline >=5	4 Participants	5 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 4; BCVA loss from baseline >=5	6 Participants	7 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 60; BCVA loss from baseline >=5	7 Participants	2 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 56; BCVA loss from baseline >=15	0 Participants	0 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 64; BCVA loss from baseline >=15	1 Participants	1 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 68; BCVA loss from baseline >=5	6 Participants	3 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 68; BCVA loss from baseline >=10	3 Participants	1 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 68; BCVA loss from baseline >=15	1 Participants	0 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 72; BCVA loss from baseline >=5	1 Participants	2 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 72; BCVA loss from baseline >=10	1 Participants	2 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 72; BCVA loss from baseline >=15	1 Participants	1 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 76; BCVA loss from baseline >=5	2 Participants	2 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 76; BCVA loss from baseline >=10	1 Participants	0 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 76; BCVA loss from baseline >=15	1 Participants	0 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 4; BCVA loss from baseline >=10	1 Participants	3 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 4; BCVA loss from baseline >=15	0 Participants	0 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 8; BCVA loss from baseline >=5	2 Participants	4 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 8; BCVA loss from baseline >=10	1 Participants	2 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 8; BCVA loss from baseline >=15	1 Participants	0 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 12; BCVA loss from baseline >=5	3 Participants	2 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 12; BCVA loss from baseline >=10	2 Participants	1 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 12; BCVA loss from baseline >=15	1 Participants	0 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 16; BCVA loss from baseline >=15	3 Participants	2 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 20; BCVA loss from baseline >=5	6 Participants	4 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 20; BCVA loss from baseline >=10	2 Participants	3 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 20; BCVA loss from baseline >=15	2 Participants	1 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 24; BCVA loss from baseline >=5	8 Participants	3 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 24; BCVA loss from baseline >=10	3 Participants	3 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 24; BCVA loss from baseline >=15	3 Participants	1 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 28; BCVA loss from baseline >=5	9 Participants	2 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 28; BCVA loss from baseline >=10	6 Participants	1 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 28; BCVA loss from baseline >=15	6 Participants	1 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 32; BCVA loss from baseline >=5	8 Participants	3 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 32; BCVA loss from baseline >=10	5 Participants	2 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 32; BCVA loss from baseline >=15	3 Participants	0 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 36; BCVA loss from baseline >=5	9 Participants	2 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 36; BCVA loss from baseline >=10	7 Participants	1 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 36; BCVA loss from baseline >=15	5 Participants	1 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 40; BCVA loss from baseline >=5	5 Participants	4 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 40; BCVA loss from baseline >=10	4 Participants	1 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 40; BCVA loss from baseline >=15	2 Participants	1 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 44; BCVA loss from baseline >=10	3 Participants	3 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 44; BCVA loss from baseline >=15	2 Participants	2 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 48; BCVA loss from baseline >=5	5 Participants	3 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 48; BCVA loss from baseline >=10	3 Participants	1 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 48; BCVA loss from baseline >=15	1 Participants	1 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 52; BCVA loss from baseline >=5	5 Participants	2 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 52; BCVA loss from baseline >=10	3 Participants	1 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 52; BCVA loss from baseline >=15	2 Participants	1 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 56; BCVA loss from baseline >=5	3 Participants	3 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 56; BCVA loss from baseline >=10	1 Participants	1 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 60; BCVA loss from baseline >=10	3 Participants	0 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 60; BCVA loss from baseline >=15	1 Participants	0 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 64; BCVA loss from baseline >=5	5 Participants	2 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 64; BCVA loss from baseline >=10	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, Week 40 to Week 52

Population: FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment. The number analyzed per row is the number of subjects from the FAS who had at least one CSFT assessment on scheduled visits over the corresponding time point

Change from baseline in central subfield thickness (CSFT) averaged over Week 40 to Week 52 , measured in µm by Spectral Domain Optical Coherence Tomography (SD-OCT)

Outcome measures

Measure	Brolucizumab 6 mg n=123 Participants 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT)	Aflibercept 2 mg n=132 Participants 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT)
Change From Baseline in CSFT Averaged Over Week 40 to Week 52	-231.8 µm Standard Deviation 188.97	-259.2 µm Standard Deviation 190.69

SECONDARY outcome

Timeframe: Baseline, Week 64 to Week 76

Population: FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment. The number analyzed per row is the number of subjects from the FAS who had at least one CSFT assessment on scheduled visits over the corresponding time point

Change from baseline in central subfield thickness (CSFT) averaged over Week 64 to Week 76, measured in µm by Spectral Domain Optical Coherence Tomography (SD-OCT)

Outcome measures

Measure	Brolucizumab 6 mg n=110 Participants 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT)	Aflibercept 2 mg n=121 Participants 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT)
Change From Baseline in CSFT Averaged Over Week 64 to Week 76	-243.6 µm Standard Deviation 201.61	-272.6 µm Standard Deviation 194.29

SECONDARY outcome

Timeframe: Baseline, and every 4 weeks from baseline up to Week 76

Population: FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment. The number analyzed per row is the number of subjects from the FAS who had CSFT data available on baseline and the specific post-baseline visit.

Change from baseline in central subfield thickness (CSFT) measured in µm by Spectral Domain Optical Coherence Tomography (SD-OCT)

Outcome measures

Measure	Brolucizumab 6 mg n=226 Participants 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT)	Aflibercept 2 mg n=224 Participants 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT)
Change From Baseline in CSFT by Visit up to Week 76 Week 4	-247.1 µm Standard Deviation 197.99	-259.4 µm Standard Deviation 185.11
Change From Baseline in CSFT by Visit up to Week 76 Week 8	-255.9 µm Standard Deviation 206.00	-270.7 µm Standard Deviation 195.49
Change From Baseline in CSFT by Visit up to Week 76 Week 12	-264.5 µm Standard Deviation 208.70	-271.9 µm Standard Deviation 194.99
Change From Baseline in CSFT by Visit up to Week 76 Week 16	-271.1 µm Standard Deviation 209.38	-276.1 µm Standard Deviation 209.70
Change From Baseline in CSFT by Visit up to Week 76 Week 20	-257.1 µm Standard Deviation 197.31	-285.2 µm Standard Deviation 210.32
Change From Baseline in CSFT by Visit up to Week 76 Week 24	-254.9 µm Standard Deviation 203.29	-286.6 µm Standard Deviation 207.67
Change From Baseline in CSFT by Visit up to Week 76 Week 28	-245.4 µm Standard Deviation 197.62	-263.6 µm Standard Deviation 197.11
Change From Baseline in CSFT by Visit up to Week 76 Week 32	-231.1 µm Standard Deviation 208.02	-262.1 µm Standard Deviation 193.80
Change From Baseline in CSFT by Visit up to Week 76 Week 36	-234.1 µm Standard Deviation 199.02	-260.8 µm Standard Deviation 195.03
Change From Baseline in CSFT by Visit up to Week 76 Week 40	-224.7 µm Standard Deviation 190.50	-259.0 µm Standard Deviation 189.01
Change From Baseline in CSFT by Visit up to Week 76 Week 44	-242.8 µm Standard Deviation 197.34	-264.1 µm Standard Deviation 192.06
Change From Baseline in CSFT by Visit up to Week 76 Week 48	-237.1 µm Standard Deviation 200.64	-279.4 µm Standard Deviation 193.41
Change From Baseline in CSFT by Visit up to Week 76 Week 52	-243.0 µm Standard Deviation 203.87	-263.4 µm Standard Deviation 190.36
Change From Baseline in CSFT by Visit up to Week 76 Week 56	-249.2 µm Standard Deviation 206.54	-271.4 µm Standard Deviation 198.09
Change From Baseline in CSFT by Visit up to Week 76 Week 60	-238.3 µm Standard Deviation 185.78	-265.3 µm Standard Deviation 187.29
Change From Baseline in CSFT by Visit up to Week 76 Week 64	-249.8 µm Standard Deviation 207.86	-266.1 µm Standard Deviation 199.79
Change From Baseline in CSFT by Visit up to Week 76 Week 68	-247.5 µm Standard Deviation 217.61	-261.1 µm Standard Deviation 192.30
Change From Baseline in CSFT by Visit up to Week 76 Week 72	-253.4 µm Standard Deviation 211.06	-279.4 µm Standard Deviation 185.21
Change From Baseline in CSFT by Visit up to Week 76 Week 76	-255.6 µm Standard Deviation 184.22	-283.7 µm Standard Deviation 197.29

SECONDARY outcome

Timeframe: Every 4 weeks from baseline up to Week 76

Population: FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment. The number analyzed per row is the number of subjects from the FAS who had data at each time point

Presence of retinal fluid (intra- and/or subretinal fluid) assessed by Spectral Domain Optical Coherence Tomography (SD-OCT)

Outcome measures

Measure	Brolucizumab 6 mg n=226 Participants 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT)	Aflibercept 2 mg n=224 Participants 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT)
Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 Week 4	83 Participants	101 Participants
Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 Week 8	56 Participants	68 Participants
Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 Week 12	41 Participants	49 Participants
Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 Week 16	34 Participants	50 Participants
Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 Week 20	33 Participants	45 Participants
Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 Week 24	35 Participants	42 Participants
Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 Week 28	47 Participants	56 Participants
Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 Week 32	58 Participants	50 Participants
Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 Week 36	48 Participants	57 Participants
Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 Week 40	42 Participants	56 Participants
Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 Week 44	43 Participants	54 Participants
Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 Week 48	44 Participants	49 Participants
Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 Week 52	34 Participants	57 Participants
Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 Week 56	34 Participants	54 Participants
Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 Week 60	39 Participants	63 Participants
Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 Week 64	31 Participants	52 Participants
Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 Week 68	34 Participants	52 Participants
Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 Week 72	33 Participants	39 Participants
Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 Week 76	16 Participants	38 Participants

SECONDARY outcome

Timeframe: Every 4 weeks from Week 4 up to Week 76

Population: FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment. The number analyzed per row is the number of subjects from the FAS who had non-missing CSFT assessment at the corresponding visit

Central subfield thickness (CSFT) is measured in µm by Spectral Domain Optical Coherence Tomography (SD-OCT)

Outcome measures

Measure	Brolucizumab 6 mg n=226 Participants 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT)	Aflibercept 2 mg n=224 Participants 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT)
Proportion of Subjects With a CSFT < 300 µm for the Study Eye by Visit up to Week 76 Week 60	83 Participants	90 Participants
Proportion of Subjects With a CSFT < 300 µm for the Study Eye by Visit up to Week 76 Week 4	167 Participants	153 Participants
Proportion of Subjects With a CSFT < 300 µm for the Study Eye by Visit up to Week 76 Week 8	172 Participants	166 Participants
Proportion of Subjects With a CSFT < 300 µm for the Study Eye by Visit up to Week 76 Week 12	156 Participants	155 Participants
Proportion of Subjects With a CSFT < 300 µm for the Study Eye by Visit up to Week 76 Week 16	137 Participants	131 Participants
Proportion of Subjects With a CSFT < 300 µm for the Study Eye by Visit up to Week 76 Week 20	120 Participants	118 Participants
Proportion of Subjects With a CSFT < 300 µm for the Study Eye by Visit up to Week 76 Week 24	127 Participants	114 Participants
Proportion of Subjects With a CSFT < 300 µm for the Study Eye by Visit up to Week 76 Week 28	109 Participants	103 Participants
Proportion of Subjects With a CSFT < 300 µm for the Study Eye by Visit up to Week 76 Week 32	92 Participants	97 Participants
Proportion of Subjects With a CSFT < 300 µm for the Study Eye by Visit up to Week 76 Week 36	96 Participants	91 Participants
Proportion of Subjects With a CSFT < 300 µm for the Study Eye by Visit up to Week 76 Week 40	94 Participants	92 Participants
Proportion of Subjects With a CSFT < 300 µm for the Study Eye by Visit up to Week 76 Week 44	95 Participants	93 Participants
Proportion of Subjects With a CSFT < 300 µm for the Study Eye by Visit up to Week 76 Week 48	89 Participants	97 Participants
Proportion of Subjects With a CSFT < 300 µm for the Study Eye by Visit up to Week 76 Week 52	86 Participants	95 Participants
Proportion of Subjects With a CSFT < 300 µm for the Study Eye by Visit up to Week 76 Week 56	86 Participants	91 Participants
Proportion of Subjects With a CSFT < 300 µm for the Study Eye by Visit up to Week 76 Week 64	85 Participants	90 Participants
Proportion of Subjects With a CSFT < 300 µm for the Study Eye by Visit up to Week 76 Week 68	82 Participants	79 Participants
Proportion of Subjects With a CSFT < 300 µm for the Study Eye by Visit up to Week 76 Week 72	70 Participants	76 Participants
Proportion of Subjects With a CSFT < 300 µm for the Study Eye by Visit up to Week 76 Week 76	59 Participants	59 Participants

SECONDARY outcome

Timeframe: Week 24 to Week 52 and Week 24 to Week 72

Population: FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment. The number analyzed per row is the number of subjects from the FAS who were on study treatment until week 52 and until week 72.

Number of administered injections during the individualized flexible treatment (IFT) period, between Week 24 and Week 52 and between Week 24 and Week 72 are presented

Outcome measures

Measure	Brolucizumab 6 mg n=111 Participants 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT)	Aflibercept 2 mg n=126 Participants 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT)
Number of Injections Between Week 24 and Week 52 and Between Week 24 and Week 72 Between Week 24 and Week 52	2.2 Injections Standard Deviation 1.69	2.5 Injections Standard Deviation 2.17
Number of Injections Between Week 24 and Week 52 and Between Week 24 and Week 72 Between Week 24 and Week 72	3.2 Injections Standard Deviation 2.54	4.0 Injections Standard Deviation 3.28

SECONDARY outcome

Timeframe: Week 20 to Week 76

Population: FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment. The number analyzed is the number of subjects from the FAS who did not discontinue from study treatment on or before Week 20.

Recurrence is defined as the need for injection while showing a lack of disease stability for the first time after Week 20 and up to Week 76.

For subjects with recurrence after the Week 20 visit, time-to-event is calculated as (first time with the lack of disease stability - the injection date on Week 20 visit + 1). For subjects without recurrence after Week 20, the censoring time will be calculated as (last visit with disease stability assessment - the injection date on Week 20 visit + 1).

Outcome measures

Measure	Brolucizumab 6 mg n=157 Participants 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT)	Aflibercept 2 mg n=159 Participants 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT)
Time to Recurrence After Week 20 and up to Week 76	12.9 Weeks Interval 12.1 to 14.4	13.1 Weeks Interval 11.3 to 17.4

SECONDARY outcome

Timeframe: Baseline to Week 76

Population: Safety Analysis Set (SAF) included all subjects who received at least one intravitreal injection.

Number of subjects with at least one ocular or non-ocular Adverse Events (AEs).

Outcome measures

Measure	Brolucizumab 6 mg n=226 Participants 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT)	Aflibercept 2 mg n=224 Participants 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT)
Number of Subjects With Ocular and Non-ocular AEs up to Week 52 and Week 76 Ocular AEs up to week 52	93 Participants	72 Participants
Number of Subjects With Ocular and Non-ocular AEs up to Week 52 and Week 76 Non-Ocular AEs up to week 52	94 Participants	112 Participants
Number of Subjects With Ocular and Non-ocular AEs up to Week 52 and Week 76 Ocular AEs up to week 76	98 Participants	75 Participants
Number of Subjects With Ocular and Non-ocular AEs up to Week 52 and Week 76 Non-Ocular AEs up to week 76	103 Participants	120 Participants

SECONDARY outcome

Timeframe: Baseline, Week 24, Week 52 and Week 76

Population: FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment. The number analyzed per row is the number of subjects from the FAS who had NEI VFQ-25 assessment on scheduled visits.

The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures a patient's subjective assessment of vision-related Quality of Life (QoL).

The 11 subscales in the VFQ-25 are general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. The scores on the subscales were added together for a total score, which ranged from 0 to 100. A higher score indicated better vision-related quality of life.

Outcome measures

Measure	Brolucizumab 6 mg n=226 Participants 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT)	Aflibercept 2 mg n=224 Participants 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT)
Change From Baseline in Patient Reported Outcomes (NEI VFQ-25) at Week 24, Week 52 and Week 76 Week 24	5.6 score on a scale Standard Deviation 11.51	6.4 score on a scale Standard Deviation 11.92
Change From Baseline in Patient Reported Outcomes (NEI VFQ-25) at Week 24, Week 52 and Week 76 Week 52	6.9 score on a scale Standard Deviation 13.21	7.6 score on a scale Standard Deviation 10.47
Change From Baseline in Patient Reported Outcomes (NEI VFQ-25) at Week 24, Week 52 and Week 76 Week 76	8.6 score on a scale Standard Deviation 13.89	7.5 score on a scale Standard Deviation 11.55

SECONDARY outcome

Timeframe: Baseline, Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76

Population: SAF-observed: Safety Analysis Set (SAF) included all subjects who received at least one intravitreal injection with brolucizumab. The number analyzed is the number of subjects from the SAF who had a value for ADA status on scheduled visits.

Anti-drug antibodies (ADA) levels were assessed from subjects assigned to brolucizumab treatment only.

Outcome measures

Measure	Brolucizumab 6 mg n=226 Participants 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT)	Aflibercept 2 mg 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT)
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Baseline · Negative	67 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Baseline · 40	29 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Baseline · 120	33 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Baseline · 360	37 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Baseline · 1080	31 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Baseline · 3240	15 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Baseline · 9720	1 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Baseline · 29200	6 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 4 · Negative	76 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 4 · 40	29 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 4 · 120	31 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 4 · 360	28 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 4 · 1080	27 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 4 · 3240	9 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 4 · 9720	6 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 4 · 29200	2 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 12 · Negative	58 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 12 · 40	17 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 12 · 120	31 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 12 · 360	25 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 12 · 1080	19 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 12 · 3240	11 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 12 · 9720	7 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 12 · 29200	2 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 24 · Negative	44 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 24 · 40	14 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 24 · 120	23 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 24 · 360	17 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 24 · 1080	19 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 24 · 3240	11 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 24 · 9720	5 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 24 · 29200	1 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 36 · Negative	33 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 36 · 40	18 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 36 · 120	19 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 36 · 360	17 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 36 · 1080	17 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 36 · 3240	8 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 36 · 9720	1 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 36 · 29200	1 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 52 · Negative	28 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 52 · 40	18 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 52 · 120	19 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 52 · 360	16 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 52 · 1080	14 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 52 · 3240	5 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 52 · 9720	1 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 52 · 29200	0 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 76 · Negative	17 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 76 · 40	6 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 76 · 120	18 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 76 · 360	14 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 76 · 1080	10 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 76 · 3240	2 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 76 · 9720	1 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 76 · 29200	0 Participants	—

Adverse Events

Brolucizumab 6mg

Serious events: 32 serious events

Other events: 109 other events

Deaths: 0 deaths

Aflibercept 2mg

Serious events: 16 serious events

Other events: 95 other events

Deaths: 2 deaths

Overall

Serious events: 48 serious events

Other events: 204 other events

Deaths: 2 deaths

Serious adverse events

Measure	Brolucizumab 6mg n=226 participants at risk Brolucizumab 6mg	Aflibercept 2mg n=224 participants at risk Aflibercept 2mg	Overall n=450 participants at risk Overall
Blood and lymphatic system disorders Anaemia	0.00% 0/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.45% 1/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.22% 1/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Cardiac disorders Angina pectoris	0.44% 1/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.22% 1/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Cardiac disorders Atrial fibrillation	0.00% 0/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.45% 1/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.22% 1/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Cardiac disorders Cardiac arrest	0.00% 0/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.45% 1/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.22% 1/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Cardiac disorders Cardiac failure	0.00% 0/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.45% 1/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.22% 1/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Cardiac disorders Cardiac failure congestive	0.00% 0/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.45% 1/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.22% 1/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Cardiac disorders Cardiac valve disease	0.00% 0/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.45% 1/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.22% 1/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Cardiac disorders Myocardial infarction	0.00% 0/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.45% 1/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.22% 1/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Cardiac disorders Palpitations	0.44% 1/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.22% 1/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Congenital, familial and genetic disorders Atrial septal defect	0.44% 1/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.22% 1/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Ear and labyrinth disorders Vertigo	0.00% 0/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.45% 1/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.22% 1/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Eye disorders Cataract - Fellow eye	0.44% 1/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.22% 1/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Eye disorders Cataract - Study eye	0.88% 2/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.44% 2/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Eye disorders Glaucoma - Fellow eye	0.44% 1/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.22% 1/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Eye disorders Glaucoma - Study eye	0.44% 1/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.22% 1/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Eye disorders Iridocyclitis - Study eye	0.44% 1/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.22% 1/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Eye disorders Retinal aneurysm - Study eye	0.00% 0/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.45% 1/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.22% 1/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Eye disorders Retinal artery occlusion - Fellow eye	0.44% 1/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.22% 1/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Eye disorders Retinal artery occlusion - Study eye	0.88% 2/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.44% 2/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Eye disorders Retinal detachment - Study eye	0.44% 1/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.22% 1/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Eye disorders Retinal occlusive vasculitis - Study eye	0.88% 2/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.44% 2/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Eye disorders Retinal vascular occlusion - Study eye	0.44% 1/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.22% 1/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Eye disorders Retinal vasculitis - Study eye	0.88% 2/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.44% 2/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Eye disorders Uveitis - Study eye	1.3% 3/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.67% 3/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Eye disorders Vitreous haemorrhage - Study eye	0.00% 0/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.45% 1/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.22% 1/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Eye disorders Vitreous opacities - Study eye	0.44% 1/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.22% 1/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Eye disorders Vitritis - Study eye	0.44% 1/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.22% 1/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Gastrointestinal disorders Mallory-Weiss syndrome	0.00% 0/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.45% 1/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.22% 1/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Gastrointestinal disorders Pancreatitis acute	0.44% 1/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.22% 1/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
General disorders Chest pain	0.44% 1/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.45% 1/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.44% 2/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Hepatobiliary disorders Cholecystitis acute	0.00% 0/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.45% 1/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.22% 1/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Infections and infestations Bronchitis	0.44% 1/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.45% 1/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.44% 2/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Infections and infestations COVID-19	0.88% 2/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.44% 2/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Infections and infestations COVID-19 pneumonia	0.44% 1/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.22% 1/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Infections and infestations Endophthalmitis - Study eye	0.88% 2/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.44% 2/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Injury, poisoning and procedural complications Dislocation of vertebra	0.00% 0/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.45% 1/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.22% 1/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Injury, poisoning and procedural complications Fall	0.44% 1/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.22% 1/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Injury, poisoning and procedural complications Subdural haemorrhage	0.44% 1/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.22% 1/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Investigations Weight increased	0.44% 1/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.22% 1/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Musculoskeletal and connective tissue disorders Muscular weakness	0.44% 1/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.22% 1/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Musculoskeletal and connective tissue disorders Osteoarthritis	0.44% 1/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.45% 1/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.44% 2/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.00% 0/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.45% 1/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.22% 1/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Eyelid seborrhoeic keratosis - Fellow eye	0.00% 0/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.45% 1/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.22% 1/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.88% 2/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.44% 2/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Nervous system disorders Cerebral infarction	0.00% 0/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.45% 1/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.22% 1/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Nervous system disorders Cerebrovascular accident	0.00% 0/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.45% 1/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.22% 1/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Nervous system disorders Ischaemic stroke	0.44% 1/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.22% 1/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Nervous system disorders Syncope	0.44% 1/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.22% 1/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Nervous system disorders Transient ischaemic attack	0.44% 1/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.22% 1/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Product Issues Device dislocation	0.00% 0/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.45% 1/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.22% 1/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Psychiatric disorders Depression	0.44% 1/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.22% 1/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Renal and urinary disorders Urinary retention	0.44% 1/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.22% 1/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Reproductive system and breast disorders Benign prostatic hyperplasia	0.44% 1/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.22% 1/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Respiratory, thoracic and mediastinal disorders Pleural mass	0.00% 0/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.45% 1/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.22% 1/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Vascular disorders Aortic stenosis	0.44% 1/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.22% 1/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Vascular disorders Vasospasm	0.00% 0/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.45% 1/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.22% 1/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment

Other adverse events

Measure	Brolucizumab 6mg n=226 participants at risk Brolucizumab 6mg	Aflibercept 2mg n=224 participants at risk Aflibercept 2mg	Overall n=450 participants at risk Overall
Eye disorders Cataract - Study eye	4.0% 9/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.89% 2/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	2.4% 11/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Eye disorders Conjunctival haemorrhage - Study eye	4.9% 11/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	5.4% 12/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	5.1% 23/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Eye disorders Dry eye - Fellow eye	2.2% 5/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	4.0% 9/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	3.1% 14/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Eye disorders Dry eye - Study eye	2.7% 6/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	4.0% 9/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	3.3% 15/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Eye disorders Eye pain - Study eye	1.8% 4/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	4.9% 11/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	3.3% 15/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Eye disorders Foreign body sensation in eyes - Study eye	2.2% 5/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.45% 1/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	1.3% 6/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Eye disorders Macular oedema - Study eye	6.6% 15/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	4.5% 10/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	5.6% 25/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Eye disorders Retinal exudates - Study eye	2.2% 5/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	3.6% 8/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	2.9% 13/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Eye disorders Retinal haemorrhage - Study eye	0.88% 2/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	3.6% 8/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	2.2% 10/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Eye disorders Uveitis - Study eye	2.2% 5/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	1.1% 5/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Eye disorders Visual acuity reduced - Study eye	6.6% 15/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	5.4% 12/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	6.0% 27/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Eye disorders Vitreous detachment - Study eye	2.2% 5/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	2.2% 5/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	2.2% 10/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Eye disorders Vitreous floaters - Study eye	4.9% 11/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	2.2% 5/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	3.6% 16/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Eye disorders Vitreous opacities - Study eye	2.2% 5/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.45% 1/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	1.3% 6/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Eye disorders Vitritis - Study eye	2.2% 5/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	1.1% 5/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Gastrointestinal disorders Toothache	2.2% 5/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	1.3% 3/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	1.8% 8/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Infections and infestations COVID-19	3.1% 7/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	3.1% 7/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	3.1% 14/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Infections and infestations Nasopharyngitis	2.7% 6/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	3.1% 7/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	2.9% 13/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Infections and infestations Upper respiratory tract infection	0.88% 2/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	3.1% 7/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	2.0% 9/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Infections and infestations Urinary tract infection	2.2% 5/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	2.7% 6/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	2.4% 11/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Injury, poisoning and procedural complications Fall	1.3% 3/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	2.2% 5/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	1.8% 8/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Investigations Intraocular pressure increased - Fellow eye	1.3% 3/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	2.7% 6/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	2.0% 9/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Investigations Intraocular pressure increased - Study eye	1.8% 4/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	3.6% 8/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	2.7% 12/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Metabolism and nutrition disorders Hypercholesterolaemia	2.2% 5/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	1.3% 3/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	1.8% 8/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Metabolism and nutrition disorders Type 2 diabetes mellitus	2.2% 5/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	1.1% 5/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Musculoskeletal and connective tissue disorders Arthralgia	0.88% 2/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	2.7% 6/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	1.8% 8/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Musculoskeletal and connective tissue disorders Back pain	0.88% 2/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	3.1% 7/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	2.0% 9/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Musculoskeletal and connective tissue disorders Osteoarthritis	2.7% 6/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.89% 2/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	1.8% 8/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Nervous system disorders Dizziness	1.8% 4/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	3.1% 7/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	2.4% 11/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Vascular disorders Hypertension	11.5% 26/226 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	8.5% 19/224 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	10.0% 45/450 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Email: novartis.email@novartis.com

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 (ie, data from all sites) in the clinical trial.
• Publication restrictions are in place

Restriction type: OTHER