Trial Outcomes & Findings for A Study to Compare SB11 (Proposed Ranibizumab Biosimilar) to Lucentis in Subjects With Neovascular Age-related Macular Degeneration (AMD) (NCT NCT03150589)
NCT ID: NCT03150589
Last Updated: 2021-05-21
Results Overview
The VA was assessed using original series ETDRS charts or 2702 series number charts.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
705 participants
Primary outcome timeframe
Baseline and Week 8
Results posted on
2021-05-21
Participant Flow
Participant milestones
| Measure |
SB11 (Proposed Ranibizumab Biosimilar)
SB11 (Proposed ranibizumab biosimilar): SB11 (proposed ranibizumab biosimilar) 0.5mg via intravitreal injection every 4 weeks
|
Lucentis (Ranibizumab)
Lucentis (ranibizumab): Lucentis (ranibizumab) 0.5mg via intravitreal injection every 4 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
351
|
354
|
|
Overall Study
COMPLETED
|
307
|
327
|
|
Overall Study
NOT COMPLETED
|
44
|
27
|
Reasons for withdrawal
| Measure |
SB11 (Proposed Ranibizumab Biosimilar)
SB11 (Proposed ranibizumab biosimilar): SB11 (proposed ranibizumab biosimilar) 0.5mg via intravitreal injection every 4 weeks
|
Lucentis (Ranibizumab)
Lucentis (ranibizumab): Lucentis (ranibizumab) 0.5mg via intravitreal injection every 4 weeks
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
16
|
9
|
|
Overall Study
Adverse Event
|
7
|
6
|
|
Overall Study
Protocol Violation
|
4
|
3
|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
|
Overall Study
Death
|
2
|
3
|
|
Overall Study
IP non-compliance and other reasons
|
12
|
3
|
Baseline Characteristics
A Study to Compare SB11 (Proposed Ranibizumab Biosimilar) to Lucentis in Subjects With Neovascular Age-related Macular Degeneration (AMD)
Baseline characteristics by cohort
| Measure |
SB11 (Proposed Ranibizumab Biosimilar)
n=351 Participants
SB11 (Proposed ranibizumab biosimilar): SB11 (proposed ranibizumab biosimilar) 0.5mg via intravitreal injection every 4 weeks
|
Lucentis (Ranibizumab)
n=354 Participants
Lucentis (ranibizumab): Lucentis (ranibizumab) 0.5mg via intravitreal injection every 4 weeks
|
Total
n=705 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
74.4 years
STANDARD_DEVIATION 8.00 • n=5 Participants
|
73.8 years
STANDARD_DEVIATION 8.92 • n=7 Participants
|
74.1 years
STANDARD_DEVIATION 8.48 • n=5 Participants
|
|
Sex: Female, Male
Female
|
202 Participants
n=5 Participants
|
201 Participants
n=7 Participants
|
403 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
149 Participants
n=5 Participants
|
153 Participants
n=7 Participants
|
302 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
51 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
297 Participants
n=5 Participants
|
300 Participants
n=7 Participants
|
597 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 8Population: Full Analysis Set
The VA was assessed using original series ETDRS charts or 2702 series number charts.
Outcome measures
| Measure |
SB11 (Proposed Ranibizumab Biosimilar)
n=346 Participants
SB11 (Proposed ranibizumab biosimilar): SB11 (proposed ranibizumab biosimilar) 0.5mg via intravitreal injection every 4 weeks
|
Lucentis (Ranibizumab)
n=348 Participants
Lucentis (ranibizumab): Lucentis (ranibizumab) 0.5mg via intravitreal injection every 4 weeks
|
|---|---|---|
|
Change From Baseline in Best Corrected Visual Acuity (BCVA)
|
6.26 letters
Standard Error 0.51
|
7.08 letters
Standard Error 0.51
|
PRIMARY outcome
Timeframe: Baseline and Week 4Population: Per-Protocol Set for CST
The average retinal thickness in the central 1-mm area in the ETDRS grid (CST) was evaluated using (Optical Coherence Tomography) OCT
Outcome measures
| Measure |
SB11 (Proposed Ranibizumab Biosimilar)
n=342 Participants
SB11 (Proposed ranibizumab biosimilar): SB11 (proposed ranibizumab biosimilar) 0.5mg via intravitreal injection every 4 weeks
|
Lucentis (Ranibizumab)
n=338 Participants
Lucentis (ranibizumab): Lucentis (ranibizumab) 0.5mg via intravitreal injection every 4 weeks
|
|---|---|---|
|
Change From Baseline in Central Subfield Thickness (CST)
|
-108.40 μm
Standard Error 4.65
|
-100.05 μm
Standard Error 4.64
|
Adverse Events
SB11 (Proposed Ranibizumab Biosimilar)
Serious events: 52 serious events
Other events: 111 other events
Deaths: 0 deaths
Lucentis (Ranibizumab)
Serious events: 52 serious events
Other events: 126 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SB11 (Proposed Ranibizumab Biosimilar)
n=350 participants at risk
SB11 (Proposed ranibizumab biosimilar): SB11 (proposed ranibizumab biosimilar) 0.5mg via intravitreal injection every 4 weeks
|
Lucentis (Ranibizumab)
n=354 participants at risk
Lucentis (ranibizumab): Lucentis (ranibizumab) 0.5mg via intravitreal injection every 4 weeks
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.29%
1/350 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.28%
1/354 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Cardiac disorders
Atrial fibrillation
|
1.1%
4/350 • Number of events 4 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.85%
3/354 • Number of events 3 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.57%
2/350 • Number of events 2 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.56%
2/354 • Number of events 2 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Cardiac disorders
Angina pectoris
|
0.29%
1/350 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.28%
1/354 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Cardiac disorders
Coronary artery disease
|
0.29%
1/350 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.00%
0/354 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Cardiac disorders
Left ventricular failure
|
0.29%
1/350 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.00%
0/354 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.29%
1/350 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.00%
0/354 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/350 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.28%
1/354 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/350 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.28%
1/354 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.29%
1/350 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.00%
0/354 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Eye disorders
Retinal haemorrhage
|
0.86%
3/350 • Number of events 4 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.28%
1/354 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Eye disorders
Cataract
|
0.57%
2/350 • Number of events 2 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.00%
0/354 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Eye disorders
Visual acuity reduced
|
0.57%
2/350 • Number of events 3 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.28%
1/354 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Eye disorders
Age-related macular degeneration
|
0.29%
1/350 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.00%
0/354 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Eye disorders
Iridocyclitis
|
0.29%
1/350 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.00%
0/354 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Eye disorders
Macular oedema
|
0.29%
1/350 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.28%
1/354 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Eye disorders
Retinal pigment epithelial tear
|
0.29%
1/350 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.00%
0/354 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Eye disorders
Subretinal fluid
|
0.29%
1/350 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.28%
1/354 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Eye disorders
Uveitis
|
0.29%
1/350 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.00%
0/354 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Eye disorders
Vitreous haemorrhage
|
0.29%
1/350 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.00%
0/354 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Eye disorders
Vitritis
|
0.29%
1/350 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.00%
0/354 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Eye disorders
Cataract subcapsular
|
0.00%
0/350 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.28%
1/354 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Eye disorders
Choroidal neovascularisation
|
0.00%
0/350 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.28%
1/354 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Eye disorders
Macular degeneration
|
0.00%
0/350 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.56%
2/354 • Number of events 2 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Eye disorders
Retinal artery occlusion
|
0.00%
0/350 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.56%
2/354 • Number of events 2 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/350 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.28%
1/354 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/350 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.28%
1/354 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.00%
0/350 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.28%
1/354 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/350 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.56%
2/354 • Number of events 2 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/350 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.28%
1/354 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
General disorders
Death
|
0.29%
1/350 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.56%
2/354 • Number of events 2 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.29%
1/350 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.00%
0/354 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.29%
1/350 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.28%
1/354 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/350 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.28%
1/354 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Infections and infestations
Endophthalmitis
|
0.57%
2/350 • Number of events 2 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.00%
0/354 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Infections and infestations
Pneumonia
|
0.29%
1/350 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.28%
1/354 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Infections and infestations
Pneumonia bacterial
|
0.29%
1/350 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.00%
0/354 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Infections and infestations
Urinary tract infection
|
0.29%
1/350 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.28%
1/354 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Infections and infestations
Bacterial colitis
|
0.00%
0/350 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.28%
1/354 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Infections and infestations
Cystitis
|
0.00%
0/350 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.56%
2/354 • Number of events 2 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Infections and infestations
Diverticulitis intestinal haemorrhagic
|
0.00%
0/350 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.28%
1/354 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Infections and infestations
Hepatitis C
|
0.00%
0/350 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.28%
1/354 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Infections and infestations
Infection
|
0.00%
0/350 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.28%
1/354 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Infections and infestations
Meningitis aseptic
|
0.00%
0/350 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.28%
1/354 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/350 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.28%
1/354 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Infections and infestations
Sepsis
|
0.00%
0/350 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.28%
1/354 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.29%
1/350 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.00%
0/354 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.29%
1/350 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.00%
0/354 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.29%
1/350 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.56%
2/354 • Number of events 2 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.29%
1/350 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.00%
0/354 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.29%
1/350 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.00%
0/354 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.29%
1/350 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.00%
0/354 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.29%
1/350 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.00%
0/354 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/350 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.28%
1/354 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/350 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.28%
1/354 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/350 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.28%
1/354 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/350 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.28%
1/354 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/350 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.28%
1/354 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/350 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.28%
1/354 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.29%
1/350 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.00%
0/354 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.29%
1/350 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.00%
0/354 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/350 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.28%
1/354 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/350 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.28%
1/354 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/350 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.28%
1/354 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/350 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.28%
1/354 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.29%
1/350 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.00%
0/354 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.29%
1/350 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.00%
0/354 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.29%
1/350 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.00%
0/354 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.29%
1/350 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.00%
0/354 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mantle cell lymphoma
|
0.29%
1/350 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.00%
0/354 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.29%
1/350 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.00%
0/354 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.29%
1/350 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.28%
1/354 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Schwannoma
|
0.29%
1/350 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.00%
0/354 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.29%
1/350 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.00%
0/354 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.29%
1/350 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.00%
0/354 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer female
|
0.00%
0/350 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.28%
1/354 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.00%
0/350 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.28%
1/354 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Nervous system disorders
Cerebral circulatory failure
|
0.29%
1/350 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.00%
0/354 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.29%
1/350 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.00%
0/354 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Nervous system disorders
Syncope
|
0.29%
1/350 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.00%
0/354 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.86%
3/350 • Number of events 3 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.28%
1/354 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Renal and urinary disorders
Renal colic
|
0.29%
1/350 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.00%
0/354 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Renal and urinary disorders
Calculus bladder
|
0.00%
0/350 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.28%
1/354 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/350 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.28%
1/354 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.00%
0/350 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.28%
1/354 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Renal and urinary disorders
Urethral stenosis
|
0.00%
0/350 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.28%
1/354 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/350 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.28%
1/354 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/350 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.28%
1/354 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.57%
2/350 • Number of events 2 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.00%
0/354 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/350 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.28%
1/354 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/350 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.28%
1/354 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Vascular disorders
Hypertension
|
0.86%
3/350 • Number of events 3 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.00%
0/354 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Vascular disorders
Aortic aneurysm
|
0.29%
1/350 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.00%
0/354 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Vascular disorders
Iliac artery embolism
|
0.29%
1/350 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.00%
0/354 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Vascular disorders
Peripheral ischaemia
|
0.29%
1/350 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.00%
0/354 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Vascular disorders
Haematoma
|
0.00%
0/350 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
0.28%
1/354 • Number of events 1 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
Other adverse events
| Measure |
SB11 (Proposed Ranibizumab Biosimilar)
n=350 participants at risk
SB11 (Proposed ranibizumab biosimilar): SB11 (proposed ranibizumab biosimilar) 0.5mg via intravitreal injection every 4 weeks
|
Lucentis (Ranibizumab)
n=354 participants at risk
Lucentis (ranibizumab): Lucentis (ranibizumab) 0.5mg via intravitreal injection every 4 weeks
|
|---|---|---|
|
Eye disorders
Neovascular age-related macular degeneration
|
7.4%
26/350 • Number of events 26 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
6.8%
24/354 • Number of events 24 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Eye disorders
Visual acuity reduced
|
6.0%
21/350 • Number of events 27 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
6.5%
23/354 • Number of events 31 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Eye disorders
Conjunctival haemorrhage
|
5.4%
19/350 • Number of events 23 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
5.4%
19/354 • Number of events 21 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Infections and infestations
Nasopharyngitis
|
11.1%
39/350 • Number of events 44 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
10.2%
36/354 • Number of events 41 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Investigations
Intraocular pressure increased
|
6.9%
24/350 • Number of events 47 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
8.2%
29/354 • Number of events 77 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
|
Vascular disorders
Hypertension
|
4.9%
17/350 • Number of events 18 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
7.9%
28/354 • Number of events 39 • From the time the subject signed the written informed consent until Week 52 (EOS Visit) or ET Visit
All AEs (ocular or non-ocular) were recorded.
|
Additional Information
Director of Clinical Trials
Samsung Bioepis Co., Ltd
Phone: +82-32-728-0371
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER