Trial Outcomes & Findings for Study of Brolucizumab in Adult Patients With Suboptimal Anatomically Controlled Neovascular Age-related Macular Degeneration (NCT NCT04264819)
NCT ID: NCT04264819
Last Updated: 2024-11-07
Results Overview
Disease activity criteria were assessed by the Investigator based on whether neovascular age-related macular degeneration (nAMD) was still active or had been re-activated. The disease was defined as active if at least one of the following criteria was observed: * Best-corrected visual acuity (BCVA) decrease ≥ 5 letters from the best value since Baseline due to disease activity * Any significant increase in central retinal thickness (CRT) * Retinal hemorrhage * Intraretinal fluid or sub-retinal fluid (SRF) due to disease activity (degenerative cysts allowed) * Increase of sub-retinal pigmented epithelium (RPE) fluid These criteria were for guidance only, Investigators could define disease activity based on their own assessment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
295 participants
Primary outcome timeframe
Week 16
Results posted on
2024-11-07
Participant Flow
Before inclusion, patients underwent a 4-to-8-Week Washout Period (from 26 to 62 days) from the last administration of a licensed anti-VEGF drug (i.e., Lucentis®, Eylea®).
Participant milestones
| Measure |
RTH258/Brolucizumab
This is a single arm study in which all patients are treated with brolucizumab 6mg; 3 loading injections (at Screening/Baseline, week 4 and week 8) followed by treat-to-control phase with adjustable treatment frequency based on disease activity from every 8 to up to 16 weeks; last treatment at week 44/46 based on the treatment regimen.
|
|---|---|
|
Overall Study
STARTED
|
295
|
|
Overall Study
Full Analysis Set (FAS)
|
289
|
|
Overall Study
COMPLETED
|
249
|
|
Overall Study
NOT COMPLETED
|
46
|
Reasons for withdrawal
| Measure |
RTH258/Brolucizumab
This is a single arm study in which all patients are treated with brolucizumab 6mg; 3 loading injections (at Screening/Baseline, week 4 and week 8) followed by treat-to-control phase with adjustable treatment frequency based on disease activity from every 8 to up to 16 weeks; last treatment at week 44/46 based on the treatment regimen.
|
|---|---|
|
Overall Study
Physician Decision
|
19
|
|
Overall Study
Adverse Event
|
12
|
|
Overall Study
Withdrawal by Subject
|
11
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Death
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
RTH258/Brolucizumab
n=295 Participants
This is a single arm study in which all patients are treated with brolucizumab 6mg; 3 loading injections (at Screening/Baseline, week 4 and week 8) followed by treat-to-control phase with adjustable treatment frequency based on disease activity from every 8 to up to 16 weeks; last treatment at week 44/46 based on the treatment regimen.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=295 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=295 Participants
|
|
Age, Categorical
>=65 years
|
273 Participants
n=295 Participants
|
|
Age, Continuous
|
76.2 Years
STANDARD_DEVIATION 8.13 • n=295 Participants
|
|
Sex: Female, Male
Female
|
183 Participants
n=295 Participants
|
|
Sex: Female, Male
Male
|
112 Participants
n=295 Participants
|
PRIMARY outcome
Timeframe: Week 16Population: Full Analysis Set - The full analysis set (FAS) comprises all patients who received at least one IVT injection of study treatment without protocol deviation with impact and with an assessment of disease activity at Week 16.
Disease activity criteria were assessed by the Investigator based on whether neovascular age-related macular degeneration (nAMD) was still active or had been re-activated. The disease was defined as active if at least one of the following criteria was observed: * Best-corrected visual acuity (BCVA) decrease ≥ 5 letters from the best value since Baseline due to disease activity * Any significant increase in central retinal thickness (CRT) * Retinal hemorrhage * Intraretinal fluid or sub-retinal fluid (SRF) due to disease activity (degenerative cysts allowed) * Increase of sub-retinal pigmented epithelium (RPE) fluid These criteria were for guidance only, Investigators could define disease activity based on their own assessment.
Outcome measures
| Measure |
RTH258/Brolucizumab
n=217 Participants
This is a single arm study in which all patients are treated with brolucizumab 6mg; 3 loading injections (at Screening/Baseline, week 4 and week 8) followed by treat-to-control phase with adjustable treatment frequency based on disease activity from every 8 to up to 16 weeks; last treatment at week 44/46 based on the treatment regimen.
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|---|---|
|
Number of Patients With no Disease Activity at Week 16 in the Study Eye
|
89 Participants
|
SECONDARY outcome
Timeframe: Week 48Population: Full Analysis Set - The full analysis set (FAS) comprises all patients who received at least one IVT injection of study treatment without protocol deviation with impact and with an assessment of disease activity at Week 48.
Disease activity criteria were assessed by the Investigator based on whether neovascular age-related macular degeneration (nAMD) was still active or had been re-activated. The disease was defined as active if at least one of the following criteria was observed: * Best-corrected visual acuity (BCVA) decrease ≥ 5 letters from the best value since Baseline due to disease activity * Any significant increase in central retinal thickness (CRT) * Retinal hemorrhage * Intraretinal fluid or sub-retinal fluid (SRF) due to disease activity (degenerative cysts allowed) * Increase of sub-retinal pigmented epithelium (RPE) fluid These criteria were for guidance only, Investigators could define disease activity based on their own assessment.
Outcome measures
| Measure |
RTH258/Brolucizumab
n=196 Participants
This is a single arm study in which all patients are treated with brolucizumab 6mg; 3 loading injections (at Screening/Baseline, week 4 and week 8) followed by treat-to-control phase with adjustable treatment frequency based on disease activity from every 8 to up to 16 weeks; last treatment at week 44/46 based on the treatment regimen.
|
|---|---|
|
Number of Patients With no Disease Activity at Week 48 in the Study Eye
|
102 Participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4,8,16, 48Population: Full Analysis Set - The full analysis set (FAS) comprises all patients who received at least one IVT injection of study treatment without protocol deviation with impact and had at least one valid post-baseline assessment.
Central Subfield Thickness Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center.
Outcome measures
| Measure |
RTH258/Brolucizumab
n=258 Participants
This is a single arm study in which all patients are treated with brolucizumab 6mg; 3 loading injections (at Screening/Baseline, week 4 and week 8) followed by treat-to-control phase with adjustable treatment frequency based on disease activity from every 8 to up to 16 weeks; last treatment at week 44/46 based on the treatment regimen.
|
|---|---|
|
Change From Baseline in CFST (Central Sub-Field Retinal Thickness) as Assessed by OCT (Optical Coherence Tomography) Over Time up to Week 48 in the Study Eye
Week 4
|
-79.19 μm
Standard Deviation 79.874
|
|
Change From Baseline in CFST (Central Sub-Field Retinal Thickness) as Assessed by OCT (Optical Coherence Tomography) Over Time up to Week 48 in the Study Eye
Week 8 (n=227)
|
-88.08 μm
Standard Deviation 91.505
|
|
Change From Baseline in CFST (Central Sub-Field Retinal Thickness) as Assessed by OCT (Optical Coherence Tomography) Over Time up to Week 48 in the Study Eye
Week 16 (n=220)
|
-48.87 μm
Standard Deviation 84.345
|
|
Change From Baseline in CFST (Central Sub-Field Retinal Thickness) as Assessed by OCT (Optical Coherence Tomography) Over Time up to Week 48 in the Study Eye
Week 48 (n = 195)
|
-66.75 μm
Standard Deviation 101.496
|
SECONDARY outcome
Timeframe: Baseline, Week 4, 8, 16, 48Population: Full Analysis Set - The full analysis set (FAS) comprises all patients who received at least one IVT injection of study treatment without protocol deviation with impact
Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. At week 8, for 1 patient, the fluid assessment was performed, but result is unknown; at week 16, for 1 patient, the fluid assessment was performed, but result is unknown; at week 48, for 2 patients, the fluid assessment was performed, but result is unknown.
Outcome measures
| Measure |
RTH258/Brolucizumab
n=289 Participants
This is a single arm study in which all patients are treated with brolucizumab 6mg; 3 loading injections (at Screening/Baseline, week 4 and week 8) followed by treat-to-control phase with adjustable treatment frequency based on disease activity from every 8 to up to 16 weeks; last treatment at week 44/46 based on the treatment regimen.
|
|---|---|
|
Absence of IRF (Intraretinal Fluid), SRF (Subretinal Fluid), and Sub-RPE (Retinal Pigmented Epithelium) Fluid as Assessed by OCT Over Time up to Week 48 in the Study Eye
Baseline - Intraretinal fluid
|
104 Participants
|
|
Absence of IRF (Intraretinal Fluid), SRF (Subretinal Fluid), and Sub-RPE (Retinal Pigmented Epithelium) Fluid as Assessed by OCT Over Time up to Week 48 in the Study Eye
Baseline - Subretinal fluid
|
245 Participants
|
|
Absence of IRF (Intraretinal Fluid), SRF (Subretinal Fluid), and Sub-RPE (Retinal Pigmented Epithelium) Fluid as Assessed by OCT Over Time up to Week 48 in the Study Eye
Baseline - Sub-RPE fluid
|
204 Participants
|
|
Absence of IRF (Intraretinal Fluid), SRF (Subretinal Fluid), and Sub-RPE (Retinal Pigmented Epithelium) Fluid as Assessed by OCT Over Time up to Week 48 in the Study Eye
Baseline - Without any fluid (IRF/SRF)
|
4 Participants
|
|
Absence of IRF (Intraretinal Fluid), SRF (Subretinal Fluid), and Sub-RPE (Retinal Pigmented Epithelium) Fluid as Assessed by OCT Over Time up to Week 48 in the Study Eye
Baseline - With any fluid (IRF/SRF)
|
285 Participants
|
|
Absence of IRF (Intraretinal Fluid), SRF (Subretinal Fluid), and Sub-RPE (Retinal Pigmented Epithelium) Fluid as Assessed by OCT Over Time up to Week 48 in the Study Eye
Week 4 - Intraretinal fluid (n=260)
|
61 Participants
|
|
Absence of IRF (Intraretinal Fluid), SRF (Subretinal Fluid), and Sub-RPE (Retinal Pigmented Epithelium) Fluid as Assessed by OCT Over Time up to Week 48 in the Study Eye
Week 4 - Subretinal fluid (n=260)
|
102 Participants
|
|
Absence of IRF (Intraretinal Fluid), SRF (Subretinal Fluid), and Sub-RPE (Retinal Pigmented Epithelium) Fluid as Assessed by OCT Over Time up to Week 48 in the Study Eye
Week 4 - Sub-RPE fluid (n=260)
|
102 Participants
|
|
Absence of IRF (Intraretinal Fluid), SRF (Subretinal Fluid), and Sub-RPE (Retinal Pigmented Epithelium) Fluid as Assessed by OCT Over Time up to Week 48 in the Study Eye
Week 4 - Without any fluid (IRF/SRF) (n=260)
|
114 Participants
|
|
Absence of IRF (Intraretinal Fluid), SRF (Subretinal Fluid), and Sub-RPE (Retinal Pigmented Epithelium) Fluid as Assessed by OCT Over Time up to Week 48 in the Study Eye
Week 4 - With any fluid (IRF/SRF) (n=260)
|
146 Participants
|
|
Absence of IRF (Intraretinal Fluid), SRF (Subretinal Fluid), and Sub-RPE (Retinal Pigmented Epithelium) Fluid as Assessed by OCT Over Time up to Week 48 in the Study Eye
Week 8 - Intraretinal fluid (n=229)
|
50 Participants
|
|
Absence of IRF (Intraretinal Fluid), SRF (Subretinal Fluid), and Sub-RPE (Retinal Pigmented Epithelium) Fluid as Assessed by OCT Over Time up to Week 48 in the Study Eye
Week 8 - Subretinal fluid (n=229)
|
72 Participants
|
|
Absence of IRF (Intraretinal Fluid), SRF (Subretinal Fluid), and Sub-RPE (Retinal Pigmented Epithelium) Fluid as Assessed by OCT Over Time up to Week 48 in the Study Eye
Week 8 - Sub-RPE fluid (n=229)
|
74 Participants
|
|
Absence of IRF (Intraretinal Fluid), SRF (Subretinal Fluid), and Sub-RPE (Retinal Pigmented Epithelium) Fluid as Assessed by OCT Over Time up to Week 48 in the Study Eye
Week 8 - Without any fluid (IRF/SRF) (n=229)
|
122 Participants
|
|
Absence of IRF (Intraretinal Fluid), SRF (Subretinal Fluid), and Sub-RPE (Retinal Pigmented Epithelium) Fluid as Assessed by OCT Over Time up to Week 48 in the Study Eye
Week 8 - With any fluid (IRF/SRF) (n=229)
|
106 Participants
|
|
Absence of IRF (Intraretinal Fluid), SRF (Subretinal Fluid), and Sub-RPE (Retinal Pigmented Epithelium) Fluid as Assessed by OCT Over Time up to Week 48 in the Study Eye
Week 16 - Intraretinal fluid (n=222)
|
70 Participants
|
|
Absence of IRF (Intraretinal Fluid), SRF (Subretinal Fluid), and Sub-RPE (Retinal Pigmented Epithelium) Fluid as Assessed by OCT Over Time up to Week 48 in the Study Eye
Week 16 - Subretinal fluid (n=222)
|
117 Participants
|
|
Absence of IRF (Intraretinal Fluid), SRF (Subretinal Fluid), and Sub-RPE (Retinal Pigmented Epithelium) Fluid as Assessed by OCT Over Time up to Week 48 in the Study Eye
Week 16 - Sub-RPE fluid (n=222)
|
99 Participants
|
|
Absence of IRF (Intraretinal Fluid), SRF (Subretinal Fluid), and Sub-RPE (Retinal Pigmented Epithelium) Fluid as Assessed by OCT Over Time up to Week 48 in the Study Eye
Week 16 - Without any fluid (IRF/SRF) (n=222)
|
69 Participants
|
|
Absence of IRF (Intraretinal Fluid), SRF (Subretinal Fluid), and Sub-RPE (Retinal Pigmented Epithelium) Fluid as Assessed by OCT Over Time up to Week 48 in the Study Eye
Week 16 - With any fluid (IRF/SRF) (n=222)
|
152 Participants
|
|
Absence of IRF (Intraretinal Fluid), SRF (Subretinal Fluid), and Sub-RPE (Retinal Pigmented Epithelium) Fluid as Assessed by OCT Over Time up to Week 48 in the Study Eye
Week 48 - Intraretinal fluid (n=198)
|
64 Participants
|
|
Absence of IRF (Intraretinal Fluid), SRF (Subretinal Fluid), and Sub-RPE (Retinal Pigmented Epithelium) Fluid as Assessed by OCT Over Time up to Week 48 in the Study Eye
Week 48 - Subretinal fluid (n=198)
|
84 Participants
|
|
Absence of IRF (Intraretinal Fluid), SRF (Subretinal Fluid), and Sub-RPE (Retinal Pigmented Epithelium) Fluid as Assessed by OCT Over Time up to Week 48 in the Study Eye
Week 48 - Sub-RPE fluid (n=198)
|
85 Participants
|
|
Absence of IRF (Intraretinal Fluid), SRF (Subretinal Fluid), and Sub-RPE (Retinal Pigmented Epithelium) Fluid as Assessed by OCT Over Time up to Week 48 in the Study Eye
Week 48 - Without any fluid (IRF/SRF) (n=198)
|
80 Participants
|
|
Absence of IRF (Intraretinal Fluid), SRF (Subretinal Fluid), and Sub-RPE (Retinal Pigmented Epithelium) Fluid as Assessed by OCT Over Time up to Week 48 in the Study Eye
Week 48 - With any fluid (IRF/SRF) (n=198)
|
116 Participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 16, 48Population: Full Analysis Set - The full analysis set (FAS) comprises all patients who received at least one IVT injection of study treatment without protocol deviation with impact.
Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center.
Outcome measures
| Measure |
RTH258/Brolucizumab
n=289 Participants
This is a single arm study in which all patients are treated with brolucizumab 6mg; 3 loading injections (at Screening/Baseline, week 4 and week 8) followed by treat-to-control phase with adjustable treatment frequency based on disease activity from every 8 to up to 16 weeks; last treatment at week 44/46 based on the treatment regimen.
|
|---|---|
|
Number of Patients With a Dry Retina (Neither IRF Nor SRF) up to Week 48 in the Study Eye
Week 48 (n=198)
|
80 Participants
|
|
Number of Patients With a Dry Retina (Neither IRF Nor SRF) up to Week 48 in the Study Eye
Baseline
|
4 Participants
|
|
Number of Patients With a Dry Retina (Neither IRF Nor SRF) up to Week 48 in the Study Eye
Week 4 (n=260)
|
114 Participants
|
|
Number of Patients With a Dry Retina (Neither IRF Nor SRF) up to Week 48 in the Study Eye
Week 8 (n=229)
|
122 Participants
|
|
Number of Patients With a Dry Retina (Neither IRF Nor SRF) up to Week 48 in the Study Eye
Week 16 (n=222)
|
69 Participants
|
SECONDARY outcome
Timeframe: Intervals of 0,4,5,6,7,8,9,10,11,12,13,14,15,16,17 WeeksPopulation: Full Analysis Set - The full analysis set (FAS) comprises all patients who received at least one IVT injection of study treatment without protocol deviation with impact
Disease activity criteria were assessed by the Investigator based on whether neovascular age-related macular degeneration (nAMD) was still active or had been re-activated. The disease was defined as active if at least one of the following criteria was observed: * Best-corrected visual acuity (BCVA) decrease ≥ 5 letters from the best value since Baseline due to disease activity * Any significant increase in central retinal thickness (CRT) * Retinal hemorrhage * Intraretinal fluid or sub-retinal fluid (SRF) due to disease activity (degenerative cysts allowed) * Increase of sub-retinal pigmented epithelium (RPE) fluid These criteria were for guidance only, Investigators could define disease activity based on their own assessment.
Outcome measures
| Measure |
RTH258/Brolucizumab
n=289 Participants
This is a single arm study in which all patients are treated with brolucizumab 6mg; 3 loading injections (at Screening/Baseline, week 4 and week 8) followed by treat-to-control phase with adjustable treatment frequency based on disease activity from every 8 to up to 16 weeks; last treatment at week 44/46 based on the treatment regimen.
|
|---|---|
|
Distribution of the Last Interval With no Disease Activity up to Week 48 in the Study Eye
q0wk
|
10 Participants
|
|
Distribution of the Last Interval With no Disease Activity up to Week 48 in the Study Eye
q4wk
|
24 Participants
|
|
Distribution of the Last Interval With no Disease Activity up to Week 48 in the Study Eye
q5wk
|
13 Participants
|
|
Distribution of the Last Interval With no Disease Activity up to Week 48 in the Study Eye
q6wk
|
7 Participants
|
|
Distribution of the Last Interval With no Disease Activity up to Week 48 in the Study Eye
q7wk
|
19 Participants
|
|
Distribution of the Last Interval With no Disease Activity up to Week 48 in the Study Eye
q8wk
|
102 Participants
|
|
Distribution of the Last Interval With no Disease Activity up to Week 48 in the Study Eye
q9wk
|
28 Participants
|
|
Distribution of the Last Interval With no Disease Activity up to Week 48 in the Study Eye
q10wk
|
10 Participants
|
|
Distribution of the Last Interval With no Disease Activity up to Week 48 in the Study Eye
q11wk
|
13 Participants
|
|
Distribution of the Last Interval With no Disease Activity up to Week 48 in the Study Eye
q12wk
|
29 Participants
|
|
Distribution of the Last Interval With no Disease Activity up to Week 48 in the Study Eye
q13wk
|
10 Participants
|
|
Distribution of the Last Interval With no Disease Activity up to Week 48 in the Study Eye
q14wk
|
3 Participants
|
|
Distribution of the Last Interval With no Disease Activity up to Week 48 in the Study Eye
q15wk
|
4 Participants
|
|
Distribution of the Last Interval With no Disease Activity up to Week 48 in the Study Eye
q16wk
|
13 Participants
|
|
Distribution of the Last Interval With no Disease Activity up to Week 48 in the Study Eye
q17wk
|
4 Participants
|
SECONDARY outcome
Timeframe: Intervals of 0,4,5,6,7,8,9,10,11,12,13,14,15,16,17 WeeksPopulation: Full Analysis Set - The full analysis set (FAS) comprises all patients who received at least one IVT injection of study treatment without protocol deviation with impact
Disease activity criteria were assessed by the Investigator based on whether neovascular age-related macular degeneration (nAMD) was still active or had been re-activated. The disease was defined as active if at least one of the following criteria was observed: * Best-corrected visual acuity (BCVA) decrease ≥ 5 letters from the best value since Baseline due to disease activity * Any significant increase in central retinal thickness (CRT) * Retinal hemorrhage * Intraretinal fluid or sub-retinal fluid (SRF) due to disease activity (degenerative cysts allowed) * Increase of sub-retinal pigmented epithelium (RPE) fluid These criteria were for guidance only, Investigators could define disease activity based on their own assessment.
Outcome measures
| Measure |
RTH258/Brolucizumab
n=289 Participants
This is a single arm study in which all patients are treated with brolucizumab 6mg; 3 loading injections (at Screening/Baseline, week 4 and week 8) followed by treat-to-control phase with adjustable treatment frequency based on disease activity from every 8 to up to 16 weeks; last treatment at week 44/46 based on the treatment regimen.
|
|---|---|
|
Distribution of the Maximal Intervals With no Disease Activity up to Week 48 in the Study Eye
q0wk
|
10 Participants
|
|
Distribution of the Maximal Intervals With no Disease Activity up to Week 48 in the Study Eye
q4wk
|
19 Participants
|
|
Distribution of the Maximal Intervals With no Disease Activity up to Week 48 in the Study Eye
q5wk
|
18 Participants
|
|
Distribution of the Maximal Intervals With no Disease Activity up to Week 48 in the Study Eye
q6wk
|
3 Participants
|
|
Distribution of the Maximal Intervals With no Disease Activity up to Week 48 in the Study Eye
q7wk
|
6 Participants
|
|
Distribution of the Maximal Intervals With no Disease Activity up to Week 48 in the Study Eye
q8wk
|
51 Participants
|
|
Distribution of the Maximal Intervals With no Disease Activity up to Week 48 in the Study Eye
q9wk
|
48 Participants
|
|
Distribution of the Maximal Intervals With no Disease Activity up to Week 48 in the Study Eye
q10wk
|
19 Participants
|
|
Distribution of the Maximal Intervals With no Disease Activity up to Week 48 in the Study Eye
q11wk
|
14 Participants
|
|
Distribution of the Maximal Intervals With no Disease Activity up to Week 48 in the Study Eye
q12wk
|
56 Participants
|
|
Distribution of the Maximal Intervals With no Disease Activity up to Week 48 in the Study Eye
q13wk
|
16 Participants
|
|
Distribution of the Maximal Intervals With no Disease Activity up to Week 48 in the Study Eye
q14wk
|
3 Participants
|
|
Distribution of the Maximal Intervals With no Disease Activity up to Week 48 in the Study Eye
q15wk
|
5 Participants
|
|
Distribution of the Maximal Intervals With no Disease Activity up to Week 48 in the Study Eye
q16wk
|
16 Participants
|
|
Distribution of the Maximal Intervals With no Disease Activity up to Week 48 in the Study Eye
q17wk
|
4 Participants
|
|
Distribution of the Maximal Intervals With no Disease Activity up to Week 48 in the Study Eye
q20wk
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 16, 48Population: Full Analysis Set - The full analysis set (FAS) comprises all patients who received at least one IVT injection of study treatment without protocol deviation with impact with at least one valid post baseline assessment.
BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual Function of the study eye was assessed using the ETDRS protocol. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning.
Outcome measures
| Measure |
RTH258/Brolucizumab
n=259 Participants
This is a single arm study in which all patients are treated with brolucizumab 6mg; 3 loading injections (at Screening/Baseline, week 4 and week 8) followed by treat-to-control phase with adjustable treatment frequency based on disease activity from every 8 to up to 16 weeks; last treatment at week 44/46 based on the treatment regimen.
|
|---|---|
|
Average Change in BCVA (Best-Corrected Visual Acuity) From Baseline up to Week 48 in the Study Eye
Week 4
|
2.6 Letters read
Standard Deviation 6.09
|
|
Average Change in BCVA (Best-Corrected Visual Acuity) From Baseline up to Week 48 in the Study Eye
Week 8 (n=231)
|
4.1 Letters read
Standard Deviation 6.68
|
|
Average Change in BCVA (Best-Corrected Visual Acuity) From Baseline up to Week 48 in the Study Eye
Week 16 (n=218)
|
4.1 Letters read
Standard Deviation 7.41
|
|
Average Change in BCVA (Best-Corrected Visual Acuity) From Baseline up to Week 48 in the Study Eye
Week 48 (n=199)
|
3.2 Letters read
Standard Deviation 9.22
|
SECONDARY outcome
Timeframe: Adverse events were reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum duration of 52 weeks.Population: Safety Analysis Set (SAF) - Includes all patients who were randomized to treatment, which includes 6 patients who were randomized but not treated.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study.
Outcome measures
| Measure |
RTH258/Brolucizumab
n=295 Participants
This is a single arm study in which all patients are treated with brolucizumab 6mg; 3 loading injections (at Screening/Baseline, week 4 and week 8) followed by treat-to-control phase with adjustable treatment frequency based on disease activity from every 8 to up to 16 weeks; last treatment at week 44/46 based on the treatment regimen.
|
|---|---|
|
Summary of Treatment-emergent Adverse Events - Overall
Any adverse event
|
165 Participants
|
|
Summary of Treatment-emergent Adverse Events - Overall
Any adverse event - Treatment-related
|
34 Participants
|
|
Summary of Treatment-emergent Adverse Events - Overall
Any adverse event - Procedure-related
|
33 Participants
|
|
Summary of Treatment-emergent Adverse Events - Overall
Serious adverse events
|
28 Participants
|
|
Summary of Treatment-emergent Adverse Events - Overall
Serious adverse events- Treatment-related
|
14 Participants
|
|
Summary of Treatment-emergent Adverse Events - Overall
Serious adverse events - Procedure-related
|
4 Participants
|
|
Summary of Treatment-emergent Adverse Events - Overall
Fatal SAEs
|
2 Participants
|
|
Summary of Treatment-emergent Adverse Events - Overall
Fatal SAEs - Treatment-related
|
0 Participants
|
|
Summary of Treatment-emergent Adverse Events - Overall
Fatal SAEs - Procedure-related
|
0 Participants
|
|
Summary of Treatment-emergent Adverse Events - Overall
AEs causing treatment discontinuation
|
39 Participants
|
|
Summary of Treatment-emergent Adverse Events - Overall
AEs causing treatment discontinuation - Treatment-related
|
30 Participants
|
|
Summary of Treatment-emergent Adverse Events - Overall
AEs causing treatment discontinuation - Procedure-related
|
5 Participants
|
|
Summary of Treatment-emergent Adverse Events - Overall
AEs leading to treatment interruption
|
0 Participants
|
SECONDARY outcome
Timeframe: Adverse events were reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum duration of 52 weeks.Population: Safety Analysis Set (SAF) - Includes all patients who were randomized to treatment.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study.
Outcome measures
| Measure |
RTH258/Brolucizumab
n=295 Participants
This is a single arm study in which all patients are treated with brolucizumab 6mg; 3 loading injections (at Screening/Baseline, week 4 and week 8) followed by treat-to-control phase with adjustable treatment frequency based on disease activity from every 8 to up to 16 weeks; last treatment at week 44/46 based on the treatment regimen.
|
|---|---|
|
Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye)
Number of patients with at least one AE
|
100 Participants
|
|
Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye)
Eye disorders
|
92 Participants
|
|
Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye)
Eye disorders-Vitreous floaters
|
15 Participants
|
|
Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye)
Eye disorders-Ocular hypertension
|
11 Participants
|
|
Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye)
Eye disorders-Vitreous detachment
|
9 Participants
|
|
Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye)
Eye disorders-Uveitis
|
8 Participants
|
|
Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye)
Eye disorders-Vitritis
|
8 Participants
|
|
Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye)
Eye disorders-Cataract
|
5 Participants
|
|
Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye)
Eye disorders-Iridocyclitis
|
5 Participants
|
|
Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye)
Eye disorders-Dry eye
|
4 Participants
|
|
Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye)
Eye disorders-Eye inflammation
|
4 Participants
|
|
Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye)
Eye disorders-Eye irritation
|
4 Participants
|
|
Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye)
Eye disorders-Eye pain
|
4 Participants
|
|
Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye)
Eye disorders-Posterior capsule opacification
|
4 Participants
|
|
Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye)
Eye disorders-Retinal hemorrhage
|
4 Participants
|
|
Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye)
Eye disorders-Vision blurred
|
4 Participants
|
|
Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye)
Eye disorders-Conjunctival hemorrhage
|
2 Participants
|
|
Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye)
Eye disorders-Ocular vasculitis
|
2 Participants
|
|
Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye)
Eye disorders-Retinal artery occlusion
|
2 Participants
|
|
Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye)
Eye disorders-Retinal occlusive vasculitis
|
2 Participants
|
|
Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye)
Eye disorders-Retinal pigment epithelial tear
|
2 Participants
|
|
Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye)
Eye disorders-Retinal tear
|
2 Participants
|
|
Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye)
Eye disorders-Retinal vasculitis
|
2 Participants
|
|
Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye)
Eye disorders-Visual acuity reduced
|
2 Participants
|
|
Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye)
Eye disorders-Anterior chamber cell
|
1 Participants
|
|
Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye)
Eye disorders-Cyclitis
|
1 Participants
|
|
Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye)
Eye disorders-Diplopia
|
1 Participants
|
|
Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye)
Eye disorders-Dyschromatopsia
|
1 Participants
|
|
Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye)
Eye disorders-Eye hematoma
|
1 Participants
|
|
Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye)
Eye disorders-Eye pruritus
|
1 Participants
|
|
Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye)
Eye disorders-Glaucoma
|
1 Participants
|
|
Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye)
Eye disorders-Keratitis
|
1 Participants
|
|
Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye)
Eye disorders-Lacrimation increased
|
1 Participants
|
|
Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye)
Eye disorders-Macular hole
|
1 Participants
|
|
Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye)
Eye disorders-Ocular hyperemia
|
1 Participants
|
|
Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye)
Eye disorders-Ocular ischemic syndrome
|
1 Participants
|
|
Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye)
Eye disorders-Retinal aneurysm
|
1 Participants
|
|
Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye)
Eye disorders-Retinal degeneration
|
1 Participants
|
|
Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye)
Eye disorders-Retinal detachment
|
1 Participants
|
|
Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye)
Eye disorders-Retinal drusen
|
1 Participants
|
|
Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye)
Eye disorders-Retinal perivascular sheathing
|
1 Participants
|
|
Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye)
Eye disorders-Serous retinal detachment
|
1 Participants
|
|
Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye)
Eye disorders-Swelling of eyelid
|
1 Participants
|
|
Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye)
Eye disorders-Visual field defect
|
1 Participants
|
|
Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye)
Eye disorders-Vitreous hemorrhage
|
1 Participants
|
|
Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye)
Eye disorders-Vitreous opacities
|
1 Participants
|
|
Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye)
Infections and infestations
|
3 Participants
|
|
Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye)
Infections and infestations-Conjunctivitis
|
2 Participants
|
|
Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye)
Infections and infestations-Herpes ophthalmic
|
1 Participants
|
|
Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye)
Injury, poisoning and procedural complications
|
3 Participants
|
|
Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye)
Injury, poisoning and procedural complications-Foreign body in eye
|
1 Participants
|
|
Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye)
Injury, poisoning and procedural complications-Procedural pain
|
1 Participants
|
|
Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye)
Injury, poisoning and procedural complications-Thermal burn
|
1 Participants
|
|
Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye)
Investigations
|
7 Participants
|
|
Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye)
Investigations-Intraocular pressure increased
|
7 Participants
|
SECONDARY outcome
Timeframe: Adverse events were reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum duration of 52 weeks.Population: Safety Analysis Set (SAF) - Includes all patients who were randomized to treatment.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study.
Outcome measures
| Measure |
RTH258/Brolucizumab
n=295 Participants
This is a single arm study in which all patients are treated with brolucizumab 6mg; 3 loading injections (at Screening/Baseline, week 4 and week 8) followed by treat-to-control phase with adjustable treatment frequency based on disease activity from every 8 to up to 16 weeks; last treatment at week 44/46 based on the treatment regimen.
|
|---|---|
|
Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Non-ocular
|
90 Participants
|
POST_HOC outcome
Timeframe: On-treatment - up to 52 weeks; Post-treatment - greater than 30 days after last treatment, up to 81 days post-treatmentPopulation: Safety Analysis Set (SAF) - Includes all patients who were randomized to treatment.
On-treatment - up to 52 weeks; Post-treatment - greater than 30 days after last treatment, up to a maximum timeframe of 81 days after treatment
Outcome measures
| Measure |
RTH258/Brolucizumab
n=295 Participants
This is a single arm study in which all patients are treated with brolucizumab 6mg; 3 loading injections (at Screening/Baseline, week 4 and week 8) followed by treat-to-control phase with adjustable treatment frequency based on disease activity from every 8 to up to 16 weeks; last treatment at week 44/46 based on the treatment regimen.
|
|---|---|
|
All Collected Deaths
On-Treatment Deaths
|
0 Participants
|
|
All Collected Deaths
Post-Treatment Deaths
|
2 Participants
|
|
All Collected Deaths
All Deaths
|
2 Participants
|
Adverse Events
RTH258/Brolucizumab
Serious events: 28 serious events
Other events: 148 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
RTH258/Brolucizumab
n=295 participants at risk
This is a single arm study in which all patients are treated with brolucizumab 6mg; 3 loading injections (at Screening/Baseline, week 4 and week 8) followed by treat-to-control phase with adjustable treatment frequency based on disease activity from every 8 to up to 16 weeks; last treatment at week 44/46 based on the treatment regimen.
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Cardiac disorders
Angina pectoris
|
0.68%
2/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Cardiac disorders
Cardiomyopathy
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Eye disorders
Cyclitis - Study eye
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Eye disorders
Eye haematoma - Study eye
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Eye disorders
Eye inflammation - Study eye
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Eye disorders
Iridocyclitis - Study eye
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Eye disorders
Retinal artery occlusion - Study eye
|
0.68%
2/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Eye disorders
Retinal occlusive vasculitis - Study eye
|
0.68%
2/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Eye disorders
Uveitis - Study eye
|
2.4%
7/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Eye disorders
Vitritis - Study eye
|
1.0%
3/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
General disorders
Chest pain
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haematoma
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Metabolism and nutrition disorders
Dehydration
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Nervous system disorders
Cerebrovascular accident
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Nervous system disorders
Headache
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Nervous system disorders
Presyncope
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
Other adverse events
| Measure |
RTH258/Brolucizumab
n=295 participants at risk
This is a single arm study in which all patients are treated with brolucizumab 6mg; 3 loading injections (at Screening/Baseline, week 4 and week 8) followed by treat-to-control phase with adjustable treatment frequency based on disease activity from every 8 to up to 16 weeks; last treatment at week 44/46 based on the treatment regimen.
|
|---|---|
|
Cardiac disorders
Arrhythmia
|
0.68%
2/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Cardiac disorders
Atrial fibrillation
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Ear and labyrinth disorders
Vertigo
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Endocrine disorders
Hypothyroidism
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Eye disorders
Age-related macular degeneration - Fellow eye
|
1.0%
3/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Eye disorders
Anterior chamber cell - Study eye
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Eye disorders
Blepharitis
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Eye disorders
Cataract - Both eye
|
1.4%
4/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Eye disorders
Cataract - Fellow eye
|
0.68%
2/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Eye disorders
Cataract - Study eye
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Eye disorders
Chalazion
|
0.68%
2/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Eye disorders
Conjunctival haemorrhage - Study eye
|
0.68%
2/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Eye disorders
Diplopia - Both eye
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Eye disorders
Dry eye - Both eye
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Eye disorders
Dry eye - Study eye
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Eye disorders
Dyschromatopsia - Both eye
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Eye disorders
Eye inflammation - Study eye
|
1.0%
3/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Eye disorders
Eye irritation - Both eye
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Eye disorders
Eye irritation - Study eye
|
1.0%
3/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Eye disorders
Eye pain - Study eye
|
1.0%
3/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Eye disorders
Eye pruritus - Study eye
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Eye disorders
Eyelid irritation
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Eye disorders
Glaucoma - Both eye
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Eye disorders
Iridocyclitis - Study eye
|
1.4%
4/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Eye disorders
Keratitis - Study eye
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Eye disorders
Lacrimation increased - Both eye
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Eye disorders
Macular hole - Study eye
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Eye disorders
Neovascular age-related macular degeneration - Fellow eye
|
3.7%
11/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Eye disorders
Neovascular age-related macular degeneration - Study eye
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Eye disorders
Ocular hyperaemia - Study eye
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Eye disorders
Ocular hypertension - Both eye
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Eye disorders
Ocular hypertension - Fellow eye
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Eye disorders
Ocular hypertension - Study eye
|
3.4%
10/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Eye disorders
Ocular vasculitis - Study eye
|
0.68%
2/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Eye disorders
Posterior capsule opacification - Both eye
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Eye disorders
Posterior capsule opacification - Fellow eye
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Eye disorders
Posterior capsule opacification - Study eye
|
1.0%
3/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Eye disorders
Retinal degeneration - Study eye
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Eye disorders
Retinal detachment - Study eye
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Eye disorders
Retinal drusen - Study eye
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Eye disorders
Retinal haemorrhage - Fellow eye
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Eye disorders
Retinal haemorrhage - Study eye
|
1.4%
4/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Eye disorders
Retinal occlusive vasculitis - Study eye
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Eye disorders
Retinal perivascular sheathing - Fellow eye
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Eye disorders
Retinal perivascular sheathing - Study eye
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Eye disorders
Retinal pigment epithelial tear - Study eye
|
0.68%
2/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Eye disorders
Retinal tear - Study eye
|
0.68%
2/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Eye disorders
Retinal vasculitis - Study eye
|
0.68%
2/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Eye disorders
Serous retinal detachment - Fellow eye
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Eye disorders
Swelling of eyelid
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Eye disorders
Uveitis - Study eye
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Eye disorders
Vision blurred - Both eye
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Eye disorders
Vision blurred - Fellow eye
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Eye disorders
Vision blurred - Study eye
|
1.0%
3/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Eye disorders
Visual acuity reduced - Study eye
|
0.68%
2/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Eye disorders
Visual field defect - Study eye
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Eye disorders
Vitreous detachment - Study eye
|
3.1%
9/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Eye disorders
Vitreous floaters - Both eye
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Eye disorders
Vitreous floaters - Study eye
|
4.1%
12/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Eye disorders
Vitreous haemorrhage - Study eye
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Eye disorders
Vitreous opacities - Study eye
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Eye disorders
Vitritis - Study eye
|
1.7%
5/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Gastrointestinal disorders
Constipation
|
0.68%
2/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Gastrointestinal disorders
Diarrhoea
|
1.0%
3/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.0%
3/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Gastrointestinal disorders
Gingival erosion
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Gastrointestinal disorders
Nausea
|
0.68%
2/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Gastrointestinal disorders
Rectal polyp
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
General disorders
Pyrexia
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Immune system disorders
Allergy to arthropod sting
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Immune system disorders
Allergy to synthetic fabric
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Immune system disorders
Drug hypersensitivity
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Immune system disorders
Seasonal allergy
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Infections and infestations
Asymptomatic COVID-19
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Infections and infestations
Bronchitis
|
1.4%
4/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Infections and infestations
COVID-19
|
2.4%
7/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Infections and infestations
Conjunctivitis - Both eye
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Infections and infestations
Conjunctivitis - Study eye
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Infections and infestations
Cystitis
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Infections and infestations
Dermatophytosis
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Infections and infestations
Gastroenteritis
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Infections and infestations
Herpes ophthalmic - Study eye
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Infections and infestations
Herpes zoster
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Infections and infestations
Influenza
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Infections and infestations
Nasopharyngitis
|
1.0%
3/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Infections and infestations
Onychomycosis
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Infections and infestations
Otitis externa
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Infections and infestations
Periodontitis
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Infections and infestations
Sinusitis
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Infections and infestations
Urinary tract infection
|
1.0%
3/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Injury, poisoning and procedural complications
Foreign body in eye - Both eye
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Injury, poisoning and procedural complications
Procedural pain - Study eye
|
0.68%
2/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Injury, poisoning and procedural complications
Thermal burn - Both eye
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Investigations
Intraocular pressure increased - Both eye
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Investigations
Intraocular pressure increased - Study eye
|
2.0%
6/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Investigations
Prostatic specific antigen increased
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Investigations
SARS-CoV-2 test positive
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
1.0%
3/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.68%
2/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.4%
4/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.68%
2/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Nervous system disorders
Amnesia
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Nervous system disorders
Headache
|
1.0%
3/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Nervous system disorders
Psychomotor skills impaired
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Nervous system disorders
Sciatica
|
1.0%
3/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Nervous system disorders
Tremor
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Psychiatric disorders
Hallucination
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Renal and urinary disorders
Hydronephrosis
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Renal and urinary disorders
Renal cyst
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Renal and urinary disorders
Urinary incontinence
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Renal and urinary disorders
Urinary tract polyp
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Vascular disorders
Arterial stenosis
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Vascular disorders
Hypertension
|
3.7%
11/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Vascular disorders
Hypotension
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
|
Vascular disorders
White coat hypertension
|
0.34%
1/295 • On treatment Adverse events are reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum time period of 52 weeks. Post-treatment Adverse events are reported for the time period greater than 30 days after last treatment, up to 81 days post-treatment.
Safety set
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER