Trial Outcomes & Findings for Comparing the Efficacy and Safety of Biosimilar Candidate Xlucane Versus Lucentis® in Patients With nAMD (NCT NCT03805100)
NCT ID: NCT03805100
Last Updated: 2023-11-13
Results Overview
Change(s) in BCVA letters at Week 8 compared to baseline using the ETDRS protocol
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
582 participants
Primary outcome timeframe
Baseline and Week 8
Results posted on
2023-11-13
Participant Flow
Participant milestones
| Measure |
Xlucane (Proposed Ranibizumab Biosimilar)
Xlucane (proposed ranibizumab biosimilar) in the study eye monthly for 52 weeks by intravitreal injection.
|
Lucentis (Ranibizumab)
Lucentis (ranibizumab) in the study eye monthly for 52 weeks by intravitreal injection
|
|---|---|---|
|
Overall Study
STARTED
|
292
|
290
|
|
Overall Study
COMPLETED
|
245
|
241
|
|
Overall Study
NOT COMPLETED
|
47
|
49
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparing the Efficacy and Safety of Biosimilar Candidate Xlucane Versus Lucentis® in Patients With nAMD
Baseline characteristics by cohort
| Measure |
Xlucane (Proposed Ranibizumab Biosimilar)
n=292 Participants
Xlucane (proposed ranibizumab biosimilar) in the study eye monthly for 52 weeks by intravitreal injection.
|
Lucentis (Ranibizumab)
n=290 Participants
Lucentis (ranibizumab) in the study eye monthly for 52 weeks by intravitreal injection
|
Total
n=582 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
34 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
258 Participants
n=5 Participants
|
258 Participants
n=7 Participants
|
516 Participants
n=5 Participants
|
|
Age, Continuous
|
74.5 Years
STANDARD_DEVIATION 8.68 • n=5 Participants
|
73.8 Years
STANDARD_DEVIATION 8.25 • n=7 Participants
|
74.1 Years
STANDARD_DEVIATION 8.47 • n=5 Participants
|
|
Sex: Female, Male
Female
|
168 Participants
n=5 Participants
|
157 Participants
n=7 Participants
|
325 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
124 Participants
n=5 Participants
|
133 Participants
n=7 Participants
|
257 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
|
44 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
248 Participants
n=5 Participants
|
248 Participants
n=7 Participants
|
496 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Best Corrected Visual Acuity
|
61.7 Letters
STANDARD_DEVIATION 8.11 • n=5 Participants
|
61.5 Letters
STANDARD_DEVIATION 8.20 • n=7 Participants
|
61.6 Letters
STANDARD_DEVIATION 8.15 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 8Change(s) in BCVA letters at Week 8 compared to baseline using the ETDRS protocol
Outcome measures
| Measure |
Xlucane (Proposed Ranibizumab Biosimilar)
n=292 Participants
Xlucane (proposed ranibizumab biosimilar) in the study eye monthly for 52 weeks by intravitreal injection.
|
Lucentis (Ranibizumab)
n=290 Participants
Lucentis (ranibizumab) in the study eye monthly for 52 weeks by intravitreal injection
|
|---|---|---|
|
Change in Best Corrected Visual Acuity (BCVA)
|
4.57 Letters
Interval 3.54 to 5.61
|
6.37 Letters
Interval 5.31 to 7.42
|
SECONDARY outcome
Timeframe: Baseline and Week 52Change in the total size of choroidal neovascular leakage area in the study eye week 52 compared to baseline measured by Fluorescein Angiography
Outcome measures
| Measure |
Xlucane (Proposed Ranibizumab Biosimilar)
n=292 Participants
Xlucane (proposed ranibizumab biosimilar) in the study eye monthly for 52 weeks by intravitreal injection.
|
Lucentis (Ranibizumab)
n=290 Participants
Lucentis (ranibizumab) in the study eye monthly for 52 weeks by intravitreal injection
|
|---|---|---|
|
Change From Baseline in the Total Size of Choroidal Neovascular Leakage Area in the Study Eye
|
-4.09 mm2
Interval -4.66 to -3.52
|
-3.71 mm2
Interval -4.28 to -3.14
|
SECONDARY outcome
Timeframe: Baseline and week 52Change From Baseline in the Total Size of Choroidal Neovascularisation in the Study Eye Measured by Fluorescein Angiography
Outcome measures
| Measure |
Xlucane (Proposed Ranibizumab Biosimilar)
n=292 Participants
Xlucane (proposed ranibizumab biosimilar) in the study eye monthly for 52 weeks by intravitreal injection.
|
Lucentis (Ranibizumab)
n=290 Participants
Lucentis (ranibizumab) in the study eye monthly for 52 weeks by intravitreal injection
|
|---|---|---|
|
Change From Baseline in the Total Size of Choroidal Neovascularisation in the Study Eye
|
-1.62 mm2
Interval -2.19 to -1.05
|
-1.11 mm2
Interval -1.68 to -0.54
|
SECONDARY outcome
Timeframe: Baseline to week 52Central Foveal Thickness in the Study Eye Measured by Optical Coherence Tomography
Outcome measures
| Measure |
Xlucane (Proposed Ranibizumab Biosimilar)
n=292 Participants
Xlucane (proposed ranibizumab biosimilar) in the study eye monthly for 52 weeks by intravitreal injection.
|
Lucentis (Ranibizumab)
n=290 Participants
Lucentis (ranibizumab) in the study eye monthly for 52 weeks by intravitreal injection
|
|---|---|---|
|
Central Foveal Thickness in the Study Eye
|
-117.44 um
Interval -125.33 to 109.55
|
-115.14 um
Interval -123.14 to -107.14
|
SECONDARY outcome
Timeframe: Baseline to week 52Percentage of Subjects With Loss of \<15 BCVA Letters Compared to Baseline in the Study Eye
Outcome measures
| Measure |
Xlucane (Proposed Ranibizumab Biosimilar)
n=292 Participants
Xlucane (proposed ranibizumab biosimilar) in the study eye monthly for 52 weeks by intravitreal injection.
|
Lucentis (Ranibizumab)
n=290 Participants
Lucentis (ranibizumab) in the study eye monthly for 52 weeks by intravitreal injection
|
|---|---|---|
|
Percentage of Subjects With Loss of <15 BCVA Letters
Missing at random (MAR)
|
94.8 percentage of responders
|
96.0 percentage of responders
|
|
Percentage of Subjects With Loss of <15 BCVA Letters
Missing completely at random (MCAR)
|
94.9 percentage of responders
|
96.1 percentage of responders
|
|
Percentage of Subjects With Loss of <15 BCVA Letters
Missing not at random (MNAR)
|
94.8 percentage of responders
|
96.1 percentage of responders
|
|
Percentage of Subjects With Loss of <15 BCVA Letters
Composite (Missing and non-evaluable data are classed as no response)
|
68.8 percentage of responders
|
67.6 percentage of responders
|
SECONDARY outcome
Timeframe: Baseline to week 52Percentage of Subjects With Gain of ≥15 BCVA Letters Compared to Baseline in the Study Eye
Outcome measures
| Measure |
Xlucane (Proposed Ranibizumab Biosimilar)
n=292 Participants
Xlucane (proposed ranibizumab biosimilar) in the study eye monthly for 52 weeks by intravitreal injection.
|
Lucentis (Ranibizumab)
n=290 Participants
Lucentis (ranibizumab) in the study eye monthly for 52 weeks by intravitreal injection
|
|---|---|---|
|
Percentage of Subjects With Gain of ≥15 BCVA Letters
Missing at random (MAR)
|
23.6 percentage of responders
|
29.7 percentage of responders
|
|
Percentage of Subjects With Gain of ≥15 BCVA Letters
Missing completely at random (MCAR)
|
23.2 percentage of responders
|
28.8 percentage of responders
|
|
Percentage of Subjects With Gain of ≥15 BCVA Letters
Missing not at random (MNAR)
|
23.6 percentage of responders
|
30.4 percentage of responders
|
|
Percentage of Subjects With Gain of ≥15 BCVA Letters
Composite (Missing and non-evaluable data are classed as no response)
|
17.1 percentage of responders
|
21.4 percentage of responders
|
SECONDARY outcome
Timeframe: Baseline to week 52Change from Baseline in the Amount of Subretinal Fluid in the Study Eye Measured by OCT
Outcome measures
| Measure |
Xlucane (Proposed Ranibizumab Biosimilar)
n=292 Participants
Xlucane (proposed ranibizumab biosimilar) in the study eye monthly for 52 weeks by intravitreal injection.
|
Lucentis (Ranibizumab)
n=290 Participants
Lucentis (ranibizumab) in the study eye monthly for 52 weeks by intravitreal injection
|
|---|---|---|
|
Subretinal Fluid in the Study Eye
|
-34.88 um
Interval -39.07 to -30.69
|
-32.93 um
Interval -37.21 to -28.65
|
SECONDARY outcome
Timeframe: Baseline to Week 52Change from Baseline in the Width of Retinal Pigment Epithelium Detachments in the Study Eye Measured by OCT
Outcome measures
| Measure |
Xlucane (Proposed Ranibizumab Biosimilar)
n=292 Participants
Xlucane (proposed ranibizumab biosimilar) in the study eye monthly for 52 weeks by intravitreal injection.
|
Lucentis (Ranibizumab)
n=290 Participants
Lucentis (ranibizumab) in the study eye monthly for 52 weeks by intravitreal injection
|
|---|---|---|
|
Width of Retinal Pigment Epithelium Detachments in the Study Eye
|
-161.39 um
Interval -387.16 to -135.62
|
-256.33 um
Interval -384.56 to -128.1
|
SECONDARY outcome
Timeframe: Day 1 to week 20Population: 70 patients were included in the PK substudy
Pharmacokinetic Plasma Ranibizumab Concentrations (sub-study)
Outcome measures
| Measure |
Xlucane (Proposed Ranibizumab Biosimilar)
n=40 Participants
Xlucane (proposed ranibizumab biosimilar) in the study eye monthly for 52 weeks by intravitreal injection.
|
Lucentis (Ranibizumab)
n=30 Participants
Lucentis (ranibizumab) in the study eye monthly for 52 weeks by intravitreal injection
|
|---|---|---|
|
Pharmacokinetic Plasma Ranibizumab Concentrations
Day 1
|
2230 pg/mL
Standard Deviation 1429
|
2190 pg/mL
Standard Deviation 1336
|
|
Pharmacokinetic Plasma Ranibizumab Concentrations
Week 20
|
2450 pg/mL
Standard Deviation 1384
|
2150 pg/mL
Standard Deviation 1233
|
SECONDARY outcome
Timeframe: Baseline to Week 52Change from Baseline in the Height of Retinal Pigment Epithelium Detachments in the Study Eye Measured by OCT
Outcome measures
| Measure |
Xlucane (Proposed Ranibizumab Biosimilar)
n=292 Participants
Xlucane (proposed ranibizumab biosimilar) in the study eye monthly for 52 weeks by intravitreal injection.
|
Lucentis (Ranibizumab)
n=290 Participants
Lucentis (ranibizumab) in the study eye monthly for 52 weeks by intravitreal injection
|
|---|---|---|
|
Height of Retinal Pigment Epithelium Detachments
|
-81.49 um
Interval -96.33 to -66.66
|
-73.15 um
Interval -88.35 to -57.95
|
Adverse Events
Xlucane (Proposed Ranibizumab Biosimilar)
Serious events: 33 serious events
Other events: 25 other events
Deaths: 8 deaths
Lucentis (Ranibizumab)
Serious events: 35 serious events
Other events: 33 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Xlucane (Proposed Ranibizumab Biosimilar)
n=292 participants at risk
Xlucane (proposed ranibizumab biosimilar) in the study eye monthly for 52 weeks by intravitreal injection.
|
Lucentis (Ranibizumab)
n=290 participants at risk
Lucentis (ranibizumab) in the study eye monthly for 52 weeks by intravitreal injection
|
|---|---|---|
|
Eye disorders
Retinal pigment epithelial tear
|
0.68%
2/292 • Number of events 2 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.34%
1/290 • Number of events 2 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Eye disorders
Retinal Haemorrhage
|
0.34%
1/292 • Number of events 1 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.34%
1/290 • Number of events 1 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Eye disorders
Macular vasospasm
|
0.34%
1/292 • Number of events 1 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.00%
0/290 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/292 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.34%
1/290 • Number of events 1 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Eye disorders
Endophthalmitis
|
0.00%
0/292 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.34%
1/290 • Number of events 1 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Infections and infestations
COVID-19
|
1.7%
5/292 • Number of events 5 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.34%
1/290 • Number of events 1 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Infections and infestations
Pneumonia
|
0.68%
2/292 • Number of events 2 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.34%
1/290 • Number of events 1 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Infections and infestations
Urinary tract infection
|
1.0%
3/292 • Number of events 3 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.00%
0/290 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Infections and infestations
Cellulitis
|
0.34%
1/292 • Number of events 1 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.34%
1/290 • Number of events 1 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Infections and infestations
Appendiceal Abscess
|
0.00%
0/292 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.34%
1/290 • Number of events 1 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/292 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.34%
1/290 • Number of events 1 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Infections and infestations
Endocarditis
|
0.00%
0/292 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.34%
1/290 • Number of events 1 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Infections and infestations
Gastroenteritis
|
0.34%
1/292 • Number of events 1 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.00%
0/290 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Infections and infestations
Staphylococcal infection
|
0.34%
1/292 • Number of events 1 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.00%
0/290 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Cardiac disorders
Artrial fibrilation
|
1.0%
3/292 • Number of events 3 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.69%
2/290 • Number of events 2 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Cardiac disorders
Myocardial infraction
|
0.00%
0/292 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
1.0%
3/290 • Number of events 3 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Cardiac disorders
Cardiac arrest
|
0.34%
1/292 • Number of events 1 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.00%
0/290 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Cardiac disorders
Cardiac failure
|
0.34%
1/292 • Number of events 1 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.00%
0/290 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.34%
1/292 • Number of events 1 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.00%
0/290 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/292 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.34%
1/290 • Number of events 1 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Cardiac disorders
Pericardial effusion
|
0.34%
1/292 • Number of events 1 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.00%
0/290 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.34%
1/292 • Number of events 1 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.00%
0/290 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal cancer
|
0.34%
1/292 • Number of events 1 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.00%
0/290 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/292 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.34%
1/290 • Number of events 1 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.00%
0/292 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.34%
1/290 • Number of events 1 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkins disease
|
0.00%
0/292 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.34%
1/290 • Number of events 1 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive breast carcinoma
|
0.00%
0/292 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.34%
1/290 • Number of events 1 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/292 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.34%
1/290 • Number of events 1 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.34%
1/292 • Number of events 1 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.00%
0/290 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/292 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.34%
1/290 • Number of events 1 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/292 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.34%
1/290 • Number of events 1 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Schwannoma
|
0.34%
1/292 • Number of events 1 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.00%
0/290 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vulva cancer
|
0.34%
1/292 • Number of events 1 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.00%
0/290 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
1.0%
3/292 • Number of events 3 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.00%
0/290 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.34%
1/292 • Number of events 1 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.34%
1/290 • Number of events 1 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/292 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.34%
1/290 • Number of events 1 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.34%
1/292 • Number of events 1 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.00%
0/290 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.34%
1/292 • Number of events 1 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.00%
0/290 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.68%
2/292 • Number of events 2 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.00%
0/290 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/292 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.34%
1/290 • Number of events 1 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/292 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.34%
1/290 • Number of events 1 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.34%
1/292 • Number of events 1 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.00%
0/290 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.34%
1/292 • Number of events 1 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.00%
0/290 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/292 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.34%
1/290 • Number of events 1 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.34%
1/292 • Number of events 1 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.00%
0/290 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/292 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.69%
2/290 • Number of events 2 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/292 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.69%
2/290 • Number of events 2 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Gastrointestinal disorders
Colonic haematoma
|
0.00%
0/292 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.34%
1/290 • Number of events 1 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.34%
1/292 • Number of events 1 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.00%
0/290 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Gastrointestinal disorders
Strangulated umbilical hernia
|
0.00%
0/292 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.34%
1/290 • Number of events 1 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
General disorders
Death
|
0.68%
2/292 • Number of events 2 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.00%
0/290 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
General disorders
Chest pain
|
0.34%
1/292 • Number of events 1 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.00%
0/290 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/292 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.34%
1/290 • Number of events 1 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
General disorders
Pyrexia
|
0.34%
1/292 • Number of events 1 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.00%
0/290 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/292 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.69%
2/290 • Number of events 2 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Nervous system disorders
Ischaemic stroke
|
0.34%
1/292 • Number of events 1 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.00%
0/290 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Nervous system disorders
Paraparesis
|
0.34%
1/292 • Number of events 1 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.00%
0/290 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Nervous system disorders
Sciatica
|
0.34%
1/292 • Number of events 1 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.00%
0/290 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.34%
1/292 • Number of events 1 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.00%
0/290 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Renal and urinary disorders
End stage renal disease
|
0.00%
0/292 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.34%
1/290 • Number of events 1 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/292 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.34%
1/290 • Number of events 1 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Renal and urinary disorders
Urinary retention
|
0.34%
1/292 • Number of events 1 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.00%
0/290 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/292 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.34%
1/290 • Number of events 1 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.34%
1/292 • Number of events 1 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.00%
0/290 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/292 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.34%
1/290 • Number of events 1 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.34%
1/292 • Number of events 1 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.00%
0/290 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.34%
1/292 • Number of events 1 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.00%
0/290 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/292 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.34%
1/290 • Number of events 1 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/292 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.34%
1/290 • Number of events 1 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Congenital, familial and genetic disorders
Hypertrophic cardiomyopathy
|
0.34%
1/292 • Number of events 1 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.00%
0/290 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/292 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.34%
1/290 • Number of events 1 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Musculoskeletal and connective tissue disorders
Athralgia
|
0.34%
1/292 • Number of events 1 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.00%
0/290 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.34%
1/292 • Number of events 1 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.00%
0/290 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Vascular disorders
Accelerated hypertension
|
0.00%
0/292 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
0.34%
1/290 • Number of events 1 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
Other adverse events
| Measure |
Xlucane (Proposed Ranibizumab Biosimilar)
n=292 participants at risk
Xlucane (proposed ranibizumab biosimilar) in the study eye monthly for 52 weeks by intravitreal injection.
|
Lucentis (Ranibizumab)
n=290 participants at risk
Lucentis (ranibizumab) in the study eye monthly for 52 weeks by intravitreal injection
|
|---|---|---|
|
Eye disorders
Conjunctival Haemorrhage
|
5.1%
15/292 • Number of events 19 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
5.5%
16/290 • Number of events 22 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
|
Vascular disorders
Hypertension
|
3.4%
10/292 • Number of events 10 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
5.9%
17/290 • Number of events 19 • From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.
AEs (ocular or non-ocular) as well as injection site reactions were recorded.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place