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Trial Outcomes & Findings for FOCUS: A Phase I/II First in Human Study to Evaluate the Safety and Efficacy of GT005 Administered in Subjects With Dry AMD (NCT NCT03846193)

NCT ID: NCT03846193

Last Updated: 2026-01-28

Results Overview

An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject. A TEAE is defined as any AE that develops after randomization or any AE already present that worsens following randomization. The primary summaries of AEs are based on TEAEs. System organ classes are sorted alphabetically, and preferred terms are sorted by decreasing overall frequency within system organ class.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

56 participants

Primary outcome timeframe

Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.

Results posted on

2026-01-28

Participant Flow

The delivery was attempted in 28 pts but was only successful in 25 pts. Of 3 pts where the GT005 delivery via Orbit SDS arms was not successful, 2 were treated via the transvitreal procedure, and 1 was disc. from treatment. (For 1 of the 3 pts, BSS delivery was successful, but not GT005 delivery.)

Participant milestones

Participant milestones
Measure
GT005 2E10 vg Via Transvitreal Procedure
GT005 2E10 vg via Transvitreal Procedure
GT005 5E10 vg Via Transvitreal Procedure
GT005 5E10 vg via Transvitreal Procedure
GT005 2E11 vg Via Transvitreal Procedure
GT005 2E11 vg via Transvitreal Procedure
GT005 5E10 vg With Orbit Subretinal Delivery System
GT005 5E10 vg with Orbit Subretinal Delivery System
GT005 2E11 vg With Orbit Subretinal Delivery System
GT005 2E11 vg with Orbit Subretinal Delivery System
Overall Study
STARTED
6
10
15
5
22
Overall Study
Initially Randomized to Receive PPY988 With the Transvitreal Procedure
4
10
15
0
0
Overall Study
Received PPY988 With the Transvitreal Procedure, After the Orbit-SDS Was Attempted Unsuccessfully
2
0
0
0
0
Overall Study
Initially Randomized to Receive PPY988 With the Orbit Subretinal Delivery System
1
0
0
2
0
Overall Study
Received PPY988 With the Transvitreal Procedure
6
10
15
0
0
Overall Study
Received PPY988 With the Orbit Subretinal Delivery System
0
0
0
3
22
Overall Study
COMPLETED
6
10
14
3
21
Overall Study
NOT COMPLETED
0
0
1
2
1

Reasons for withdrawal

Reasons for withdrawal
Measure
GT005 2E10 vg Via Transvitreal Procedure
GT005 2E10 vg via Transvitreal Procedure
GT005 5E10 vg Via Transvitreal Procedure
GT005 5E10 vg via Transvitreal Procedure
GT005 2E11 vg Via Transvitreal Procedure
GT005 2E11 vg via Transvitreal Procedure
GT005 5E10 vg With Orbit Subretinal Delivery System
GT005 5E10 vg with Orbit Subretinal Delivery System
GT005 2E11 vg With Orbit Subretinal Delivery System
GT005 2E11 vg with Orbit Subretinal Delivery System
Overall Study
Physician Decision
0
0
1
0
0
Overall Study
Lost to Follow-up
0
0
0
0
1
Overall Study
switched to the GT005 2E10 vg via Transvitreal Procedure
0
0
0
2
0

Baseline Characteristics

FOCUS: A Phase I/II First in Human Study to Evaluate the Safety and Efficacy of GT005 Administered in Subjects With Dry AMD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
GT005 2E10 vg Via Transvitreal Procedure
n=6 Participants
GT005 2E10 vg via Transvitreal Procedure
GT005 5E10 vg Via Transvitreal Procedure
n=10 Participants
GT005 5E10 vg via Transvitreal Procedure
GT005 2E11 vg Via Transvitreal Procedure
n=15 Participants
GT005 2E11 vg via Transvitreal Procedure
GT005 5E10 vg With Orbit Subretinal Delivery System
n=3 Participants
GT005 5E10 vg with Orbit Subretinal Delivery System
GT005 2E11 vg With Orbit Subretinal Delivery System
n=22 Participants
GT005 2E11 vg with Orbit Subretinal Delivery System
Total
n=56 Participants
Total of all reporting groups
Age, Continuous
81.7 Years
STANDARD_DEVIATION 8.21 • n=41 Participants
79.0 Years
STANDARD_DEVIATION 5.12 • n=1581 Participants
80.5 Years
STANDARD_DEVIATION 4.02 • n=4626 Participants
75.7 Years
STANDARD_DEVIATION 4.73 • n=72 Participants
77.3 Years
STANDARD_DEVIATION 6.60
78.9 Years
STANDARD_DEVIATION 5.93 • n=140 Participants
Sex: Female, Male
Female
5 Participants
n=41 Participants
6 Participants
n=1581 Participants
11 Participants
n=4626 Participants
3 Participants
n=72 Participants
14 Participants
39 Participants
n=140 Participants
Sex: Female, Male
Male
1 Participants
n=41 Participants
4 Participants
n=1581 Participants
4 Participants
n=4626 Participants
0 Participants
n=72 Participants
8 Participants
17 Participants
n=140 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=41 Participants
0 Participants
n=1581 Participants
0 Participants
n=4626 Participants
0 Participants
n=72 Participants
0 Participants
0 Participants
n=140 Participants
Race (NIH/OMB)
Asian
0 Participants
n=41 Participants
0 Participants
n=1581 Participants
1 Participants
n=4626 Participants
0 Participants
n=72 Participants
0 Participants
1 Participants
n=140 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=41 Participants
0 Participants
n=1581 Participants
0 Participants
n=4626 Participants
0 Participants
n=72 Participants
0 Participants
0 Participants
n=140 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=41 Participants
0 Participants
n=1581 Participants
0 Participants
n=4626 Participants
0 Participants
n=72 Participants
0 Participants
0 Participants
n=140 Participants
Race (NIH/OMB)
White
6 Participants
n=41 Participants
10 Participants
n=1581 Participants
14 Participants
n=4626 Participants
3 Participants
n=72 Participants
22 Participants
55 Participants
n=140 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=41 Participants
0 Participants
n=1581 Participants
0 Participants
n=4626 Participants
0 Participants
n=72 Participants
0 Participants
0 Participants
n=140 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=41 Participants
0 Participants
n=1581 Participants
0 Participants
n=4626 Participants
0 Participants
n=72 Participants
0 Participants
0 Participants
n=140 Participants

PRIMARY outcome

Timeframe: Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.

Population: Safety Analysis Set - All treated patients

An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject. A TEAE is defined as any AE that develops after randomization or any AE already present that worsens following randomization. The primary summaries of AEs are based on TEAEs. System organ classes are sorted alphabetically, and preferred terms are sorted by decreasing overall frequency within system organ class.

Outcome measures

Outcome measures
Measure
GT005 2E11 vg With Orbit Subretinal Delivery System
n=22 Participants
GT005 2E11 vg with Orbit Subretinal Delivery System
GT005 2E10 vg Via Transvitreal Procedure
n=6 Participants
GT005 2E10 vg via Transvitreal Procedure
GT005 5E10 vg Via Transvitreal Procedure
n=10 Participants
GT005 5E10 vg via Transvitreal Procedure
GT005 2E11 vg Via Transvitreal Procedure
n=15 Participants
GT005 2E11 vg via Transvitreal Procedure
GT005 5E10 vg With Orbit Subretinal Delivery System
n=3 Participants
GT005 5E10 vg with Orbit Subretinal Delivery System
Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye
-Vision blurred
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye
-Visual impairment
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye
-Procedural pain
1 Participants
0 Participants
0 Participants
3 Participants
0 Participants
Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye
Subjects with at least one TEAE
21 Participants
3 Participants
7 Participants
14 Participants
3 Participants
Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye
Congenital, familial and genetic disorders
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye
-Corneal dystrophy
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye
Eye disorders
21 Participants
3 Participants
6 Participants
13 Participants
3 Participants
Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye
-Retinal pigmentation
8 Participants
0 Participants
4 Participants
10 Participants
0 Participants
Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye
-Conjunctival haemorrhage
15 Participants
0 Participants
0 Participants
0 Participants
3 Participants
Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye
-Cataract
2 Participants
1 Participants
3 Participants
7 Participants
0 Participants
Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye
-Retinal haemorrhage
5 Participants
0 Participants
2 Participants
1 Participants
3 Participants
Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye
-Dry eye
2 Participants
1 Participants
2 Participants
2 Participants
0 Participants
Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye
-Anterior chamber cell
3 Participants
0 Participants
0 Participants
1 Participants
1 Participants
Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye
-Retinal tear
4 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye
-Blepharitis
0 Participants
0 Participants
3 Participants
0 Participants
0 Participants
Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye
-Conjunctival hyperaemia
2 Participants
0 Participants
0 Participants
1 Participants
0 Participants
Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye
-Neovascular age-related macular degeneration
2 Participants
0 Participants
0 Participants
0 Participants
1 Participants
Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye
-Visual field defect
0 Participants
0 Participants
0 Participants
3 Participants
0 Participants
Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye
-Charles Bonnet syndrome
0 Participants
1 Participants
0 Participants
1 Participants
0 Participants
Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye
-Eye pain
1 Participants
0 Participants
0 Participants
1 Participants
0 Participants
Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye
-Eyelid ptosis
1 Participants
0 Participants
0 Participants
1 Participants
0 Participants
Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye
-Visual acuity reduced
1 Participants
1 Participants
0 Participants
0 Participants
0 Participants
Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye
-Vitreous floaters
0 Participants
0 Participants
0 Participants
1 Participants
1 Participants
Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye
-Central vision loss
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye
-Chalazion
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye
-Choroidal haemorrhage
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye
-Choroidal neovascularisation
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye
-Conjunctival deposit
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye
-Corneal oedema
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye
-Dacryostenosis acquired
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye
-Diplopia
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye
-Eye discharge
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye
-Eye pruritus
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye
-Eyelid irritation
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye
-Foreign body sensation in eyes
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye
-Glaucoma
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye
-Iridocyclitis
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye
-Keratitis
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye
-Macular hole
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye
-Ocular discomfort
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye
-Ocular hypertension
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye
-Optic disc haemorrhage
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye
-Periorbital oedema
0 Participants
1 Participants
0 Participants
0 Participants
0 Participants
Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye
-Posterior capsule opacification
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye
-Retinal depigmentation
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye
Infections and infestations
2 Participants
0 Participants
3 Participants
0 Participants
0 Participants
Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye
-Conjunctivitis
2 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye
-Conjunctivitis viral
0 Participants
0 Participants
2 Participants
0 Participants
0 Participants
Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye
-Conjunctivitis bacterial
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye
Injury, poisoning and procedural complications
3 Participants
0 Participants
0 Participants
4 Participants
0 Participants
Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye
-Corneal abrasion
1 Participants
0 Participants
0 Participants
1 Participants
0 Participants
Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye
-Post procedural discomfort
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye
-Suture related complication
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye
Investigations
1 Participants
0 Participants
0 Participants
1 Participants
1 Participants
Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye
-Intraocular pressure increased
1 Participants
0 Participants
0 Participants
1 Participants
1 Participants
Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye
Nervous system disorders
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye
-Ophthalmic migraine
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants

PRIMARY outcome

Timeframe: Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.

Population: Safety Analysis Set - All treated patients

An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject. A TEAE is defined as any AE that develops after randomization or any AE already present that worsens following randomization. The primary summaries of AEs are based on TEAEs.

Outcome measures

Outcome measures
Measure
GT005 2E11 vg With Orbit Subretinal Delivery System
n=22 Participants
GT005 2E11 vg with Orbit Subretinal Delivery System
GT005 2E10 vg Via Transvitreal Procedure
n=6 Participants
GT005 2E10 vg via Transvitreal Procedure
GT005 5E10 vg Via Transvitreal Procedure
n=10 Participants
GT005 5E10 vg via Transvitreal Procedure
GT005 2E11 vg Via Transvitreal Procedure
n=15 Participants
GT005 2E11 vg via Transvitreal Procedure
GT005 5E10 vg With Orbit Subretinal Delivery System
n=3 Participants
GT005 5E10 vg with Orbit Subretinal Delivery System
Summary of Non-Ocular Treatment Emergent Adverse Events
16 Participants
4 Participants
10 Participants
14 Participants
3 Participants

PRIMARY outcome

Timeframe: Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.

Population: Safety Analysis Set - All treated patients

An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject. A TEAE is defined as any AE that develops after randomization or any AE already present that worsens following randomization. The primary summaries of AEs are based on TEAEs.

Outcome measures

Outcome measures
Measure
GT005 2E11 vg With Orbit Subretinal Delivery System
n=22 Participants
GT005 2E11 vg with Orbit Subretinal Delivery System
GT005 2E10 vg Via Transvitreal Procedure
n=6 Participants
GT005 2E10 vg via Transvitreal Procedure
GT005 5E10 vg Via Transvitreal Procedure
n=10 Participants
GT005 5E10 vg via Transvitreal Procedure
GT005 2E11 vg Via Transvitreal Procedure
n=15 Participants
GT005 2E11 vg via Transvitreal Procedure
GT005 5E10 vg With Orbit Subretinal Delivery System
n=3 Participants
GT005 5E10 vg with Orbit Subretinal Delivery System
Summary of Ocular Serious Treatment-Emergent Adverse Events in the Study Eye by System Organ Class and Preferred
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants

SECONDARY outcome

Timeframe: Up to Week 240

Population: Full Analysis Set - All treated patients with a valid measurement without a protocol deviation with impact

Best corrected visual acuity (BCVA) was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning.

Outcome measures

Outcome measures
Measure
GT005 2E11 vg With Orbit Subretinal Delivery System
n=22 Participants
GT005 2E11 vg with Orbit Subretinal Delivery System
GT005 2E10 vg Via Transvitreal Procedure
n=6 Participants
GT005 2E10 vg via Transvitreal Procedure
GT005 5E10 vg Via Transvitreal Procedure
n=10 Participants
GT005 5E10 vg via Transvitreal Procedure
GT005 2E11 vg Via Transvitreal Procedure
n=15 Participants
GT005 2E11 vg via Transvitreal Procedure
GT005 5E10 vg With Orbit Subretinal Delivery System
n=3 Participants
GT005 5E10 vg with Orbit Subretinal Delivery System
Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye
Week 144 (n=2,6,10,3,2)
56.00 ETDRS letters read
Standard Deviation 2.828
26.50 ETDRS letters read
Standard Deviation 28.991
42.50 ETDRS letters read
Standard Deviation 9.628
43.90 ETDRS letters read
Standard Deviation 17.515
64.00 ETDRS letters read
Standard Deviation 18.520
Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye
Week 1
52.59 ETDRS letters read
Standard Deviation 15.822
39.33 ETDRS letters read
Standard Deviation 16.145
47.20 ETDRS letters read
Standard Deviation 16.151
47.20 ETDRS letters read
Standard Deviation 17.449
62.00 ETDRS letters read
Standard Deviation 17.436
Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye
Week 5 (n=6,10,14,3,22)
52.14 ETDRS letters read
Standard Deviation 18.838
42.00 ETDRS letters read
Standard Deviation 20.258
46.90 ETDRS letters read
Standard Deviation 13.916
45.57 ETDRS letters read
Standard Deviation 19.747
62.67 ETDRS letters read
Standard Deviation 19.425
Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye
Week 8 (n=3,4,6,3,21)
52.52 ETDRS letters read
Standard Deviation 18.101
60.33 ETDRS letters read
Standard Deviation 9.074
55.25 ETDRS letters read
Standard Deviation 9.674
55.67 ETDRS letters read
Standard Deviation 12.675
65.33 ETDRS letters read
Standard Deviation 16.442
Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye
Week 12 (n=6,10,11,3,22)
54.68 ETDRS letters read
Standard Deviation 17.705
44.33 ETDRS letters read
Standard Deviation 21.153
46.00 ETDRS letters read
Standard Deviation 15.563
54.73 ETDRS letters read
Standard Deviation 16.032
66.67 ETDRS letters read
Standard Deviation 16.166
Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye
Week 24 (n=6,10,13,3,21)
52.76 ETDRS letters read
Standard Deviation 18.144
42.67 ETDRS letters read
Standard Deviation 24.262
44.60 ETDRS letters read
Standard Deviation 13.810
48.92 ETDRS letters read
Standard Deviation 20.056
66.67 ETDRS letters read
Standard Deviation 19.218
Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye
Week 36 (n=6,6,15,3,21)
52.29 ETDRS letters read
Standard Deviation 18.078
39.00 ETDRS letters read
Standard Deviation 21.790
53.17 ETDRS letters read
Standard Deviation 12.983
43.80 ETDRS letters read
Standard Deviation 20.640
65.00 ETDRS letters read
Standard Deviation 21.932
Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye
Week 48 (n=5,9,14,3,21)
51.19 ETDRS letters read
Standard Deviation 19.577
40.60 ETDRS letters read
Standard Deviation 19.204
47.22 ETDRS letters read
Standard Deviation 13.953
47.86 ETDRS letters read
Standard Deviation 16.176
64.00 ETDRS letters read
Standard Deviation 20.518
Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye
Week 72 (n=3,8,14,3,18)
51.72 ETDRS letters read
Standard Deviation 18.162
32.67 ETDRS letters read
Standard Deviation 20.744
46.63 ETDRS letters read
Standard Deviation 15.408
46.93 ETDRS letters read
Standard Deviation 13.658
57.33 ETDRS letters read
Standard Deviation 16.258
Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye
Week 96 (n=4,8,14,3,18)
51.72 ETDRS letters read
Standard Deviation 19.393
31.00 ETDRS letters read
Standard Deviation 21.494
44.13 ETDRS letters read
Standard Deviation 12.484
43.57 ETDRS letters read
Standard Deviation 18.110
64.67 ETDRS letters read
Standard Deviation 24.583
Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye
Week 192 (n=2,3,7,0,0)
—
26.50 ETDRS letters read
Standard Deviation 19.092
35.33 ETDRS letters read
Standard Deviation 8.505
36.43 ETDRS letters read
Standard Deviation 15.404
—
Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye
Week 240 (n=2,1,2,0,0)
—
25.50 ETDRS letters read
Standard Deviation 16.263
28.00 ETDRS letters read
25.50 ETDRS letters read
Standard Deviation 7.778
—

SECONDARY outcome

Timeframe: Up to Week 240

Population: Full Analysis Set - All treated patients with a valid measurement without a protocol deviation with impact

Low-Luminance Deficit best corrected visual acuity (BCVA-LLVA) was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning.

Outcome measures

Outcome measures
Measure
GT005 2E11 vg With Orbit Subretinal Delivery System
n=22 Participants
GT005 2E11 vg with Orbit Subretinal Delivery System
GT005 2E10 vg Via Transvitreal Procedure
n=6 Participants
GT005 2E10 vg via Transvitreal Procedure
GT005 5E10 vg Via Transvitreal Procedure
n=10 Participants
GT005 5E10 vg via Transvitreal Procedure
GT005 2E11 vg Via Transvitreal Procedure
n=15 Participants
GT005 2E11 vg via Transvitreal Procedure
GT005 5E10 vg With Orbit Subretinal Delivery System
n=3 Participants
GT005 5E10 vg with Orbit Subretinal Delivery System
Low-Luminance Deficit Best Corrected Visual Acuity (BCVA-LLVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye
Week 36 (n=4,6,15,3,20)
20.10 ETDRS letters read
Standard Deviation 14.242
26.75 ETDRS letters read
Standard Deviation 24.865
21.00 ETDRS letters read
Standard Deviation 14.656
15.07 ETDRS letters read
Standard Deviation 15.144
30.00 ETDRS letters read
Standard Deviation 30.806
Low-Luminance Deficit Best Corrected Visual Acuity (BCVA-LLVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye
Week 24 (n=6,10,13,3,21)
22.52 ETDRS letters read
Standard Deviation 14.473
32.25 ETDRS letters read
Standard Deviation 29.205
15.80 ETDRS letters read
Standard Deviation 15.061
17.23 ETDRS letters read
Standard Deviation 13.893
27.00 ETDRS letters read
Standard Deviation 20.952
Low-Luminance Deficit Best Corrected Visual Acuity (BCVA-LLVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye
Week 48 (n=5,9,14,3,21)
18.48 ETDRS letters read
Standard Deviation 13.938
19.60 ETDRS letters read
Standard Deviation 14.415
15.11 ETDRS letters read
Standard Deviation 13.968
17.36 ETDRS letters read
Standard Deviation 15.736
31.67 ETDRS letters read
Standard Deviation 24.194
Low-Luminance Deficit Best Corrected Visual Acuity (BCVA-LLVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye
Week 72 (n=3,8,14,3,18)
21.22 ETDRS letters read
Standard Deviation 12.735
20.33 ETDRS letters read
Standard Deviation 14.154
13.13 ETDRS letters read
Standard Deviation 9.538
15.36 ETDRS letters read
Standard Deviation 17.095
33.67 ETDRS letters read
Standard Deviation 25.007
Low-Luminance Deficit Best Corrected Visual Acuity (BCVA-LLVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye
Week 96 (n=4,8,14,3,18)
21.56 ETDRS letters read
Standard Deviation 13.984
16.25 ETDRS letters read
Standard Deviation 9.215
8.88 ETDRS letters read
Standard Deviation 4.643
13.07 ETDRS letters read
Standard Deviation 15.711
36.00 ETDRS letters read
Standard Deviation 23.065
Low-Luminance Deficit Best Corrected Visual Acuity (BCVA-LLVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye
Week 144 (n=2,6,10,3,2)
26.00 ETDRS letters read
Standard Deviation 26.870
5.50 ETDRS letters read
Standard Deviation 6.364
6.50 ETDRS letters read
Standard Deviation 4.550
18.80 ETDRS letters read
Standard Deviation 18.760
39.67 ETDRS letters read
Standard Deviation 22.679
Low-Luminance Deficit Best Corrected Visual Acuity (BCVA-LLVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye
Week 192 (n=2,3,7,0,0)
—
2.00 ETDRS letters read
Standard Deviation 1.414
5.00 ETDRS letters read
Standard Deviation 1.414
13.00 ETDRS letters read
Standard Deviation 9.220
—
Low-Luminance Deficit Best Corrected Visual Acuity (BCVA-LLVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye
Week 240 (n=2,1,2,0,0)
—
7.50 ETDRS letters read
Standard Deviation 2.121
9.00 ETDRS letters read
5.50 ETDRS letters read
Standard Deviation 3.536
—
Low-Luminance Deficit Best Corrected Visual Acuity (BCVA-LLVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye
Week 12 (n=3,9,11,3,22)
24.82 ETDRS letters read
Standard Deviation 16.229
40.00 ETDRS letters read
Standard Deviation 21.517
14.67 ETDRS letters read
Standard Deviation 17.951
18.91 ETDRS letters read
Standard Deviation 14.321
28.67 ETDRS letters read
Standard Deviation 17.214

SECONDARY outcome

Timeframe: Up to Week 240

Population: Full Analysis Set - All treated patients with a valid measurement without a protocol deviation with impact

Macular sensitivity as assessed by mesopic Microperimetry. Mesopic Microperimetry (MP) Bivariate contour ellipse area (BCEA) 63 Area.

Outcome measures

Outcome measures
Measure
GT005 2E11 vg With Orbit Subretinal Delivery System
n=11 Participants
GT005 2E11 vg with Orbit Subretinal Delivery System
GT005 2E10 vg Via Transvitreal Procedure
n=3 Participants
GT005 2E10 vg via Transvitreal Procedure
GT005 5E10 vg Via Transvitreal Procedure
n=9 Participants
GT005 5E10 vg via Transvitreal Procedure
GT005 2E11 vg Via Transvitreal Procedure
n=14 Participants
GT005 2E11 vg via Transvitreal Procedure
GT005 5E10 vg With Orbit Subretinal Delivery System
n=3 Participants
GT005 5E10 vg with Orbit Subretinal Delivery System
Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 63 Area (deg2)
Week 24 (n=3,9,10,3,11)
10.38 degrees squared (deg2)
Standard Deviation 11.050
16.17 degrees squared (deg2)
Standard Deviation 15.970
17.10 degrees squared (deg2)
Standard Deviation 17.891
12.13 degrees squared (deg2)
Standard Deviation 11.483
14.40 degrees squared (deg2)
Standard Deviation 20.809
Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 63 Area (deg2)
Week 12 (n=2,9,11,1,10)
5.97 degrees squared (deg2)
Standard Deviation 3.726
16.80 degrees squared (deg2)
Standard Deviation 5.940
15.64 degrees squared (deg2)
Standard Deviation 13.013
7.82 degrees squared (deg2)
Standard Deviation 8.232
36.90 degrees squared (deg2)
Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 63 Area (deg2)
Week 48 (n=2,9,14,2,10)
11.34 degrees squared (deg2)
Standard Deviation 7.527
8.50 degrees squared (deg2)
Standard Deviation 3.677
19.41 degrees squared (deg2)
Standard Deviation 19.557
11.96 degrees squared (deg2)
Standard Deviation 7.939
48.55 degrees squared (deg2)
Standard Deviation 50.134
Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 63 Area (deg2)
Week 72 (n=1,8,13,2,10)
9.66 degrees squared (deg2)
Standard Deviation 6.935
17.80 degrees squared (deg2)
13.33 degrees squared (deg2)
Standard Deviation 6.887
12.10 degrees squared (deg2)
Standard Deviation 7.970
27.65 degrees squared (deg2)
Standard Deviation 38.254
Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 63 Area (deg2)
Week 96 (n=2,8,13,1,7)
6.11 degrees squared (deg2)
Standard Deviation 4.171
10.90 degrees squared (deg2)
Standard Deviation 2.546
14.65 degrees squared (deg2)
Standard Deviation 10.059
10.40 degrees squared (deg2)
Standard Deviation 6.389
0.30 degrees squared (deg2)
Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 63 Area (deg2)
Week 144 (n=1,5,8,2,0)
—
12.20 degrees squared (deg2)
18.80 degrees squared (deg2)
Standard Deviation 18.404
13.05 degrees squared (deg2)
Standard Deviation 7.505
4.30 degrees squared (deg2)
Standard Deviation 5.233
Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 63 Area (deg2)
Week 192 (1,2,7,0,0)
—
38.90 degrees squared (deg2)
7.70 degrees squared (deg2)
Standard Deviation 0.283
13.80 degrees squared (deg2)
Standard Deviation 8.565
—
Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 63 Area (deg2)
Week 240 (1,1,2,0,0)
—
40.20 degrees squared (deg2)
11.10 degrees squared (deg2)
18.85 degrees squared (deg2)
Standard Deviation 24.395
—

SECONDARY outcome

Timeframe: Up to Week 240

Population: Full Analysis Set - All treated patients with a valid measurement without a protocol deviation with impact

Macular sensitivity as assessed by mesopic Microperimetry. Mesopic Microperimetry (MP) Bivariate contour ellipse area (BCEA) 95 Area.

Outcome measures

Outcome measures
Measure
GT005 2E11 vg With Orbit Subretinal Delivery System
n=11 Participants
GT005 2E11 vg with Orbit Subretinal Delivery System
GT005 2E10 vg Via Transvitreal Procedure
n=3 Participants
GT005 2E10 vg via Transvitreal Procedure
GT005 5E10 vg Via Transvitreal Procedure
n=9 Participants
GT005 5E10 vg via Transvitreal Procedure
GT005 2E11 vg Via Transvitreal Procedure
n=14 Participants
GT005 2E11 vg via Transvitreal Procedure
GT005 5E10 vg With Orbit Subretinal Delivery System
n=3 Participants
GT005 5E10 vg with Orbit Subretinal Delivery System
Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 95 Area (deg2)
Week 12 (n=2,9,11,1,10)
17.81 degrees squared (deg2)
Standard Deviation 11.120
50.40 degrees squared (deg2)
Standard Deviation 17.819
46.86 degrees squared (deg2)
Standard Deviation 39.037
23.43 degrees squared (deg2)
Standard Deviation 24.638
110.70 degrees squared (deg2)
Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 95 Area (deg2)
Week 24 (n=3,9,10,3,11)
31.09 degrees squared (deg2)
Standard Deviation 33.157
48.37 degrees squared (deg2)
Standard Deviation 47.853
51.20 degrees squared (deg2)
Standard Deviation 53.652
36.28 degrees squared (deg2)
Standard Deviation 34.454
43.23 degrees squared (deg2)
Standard Deviation 62.405
Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 95 Area (deg2)
Week 48 (n=2,9,14,2,10)
33.96 degrees squared (deg2)
Standard Deviation 22.632
25.45 degrees squared (deg2)
Standard Deviation 10.960
58.17 degrees squared (deg2)
Standard Deviation 58.589
35.79 degrees squared (deg2)
Standard Deviation 23.804
145.40 degrees squared (deg2)
Standard Deviation 150.331
Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 95 Area (deg2)
Week 72 (n=1,8,13,2,10)
28.90 degrees squared (deg2)
Standard Deviation 20.743
53.40 degrees squared (deg2)
39.94 degrees squared (deg2)
Standard Deviation 20.603
36.28 degrees squared (deg2)
Standard Deviation 23.848
82.90 degrees squared (deg2)
Standard Deviation 114.693
Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 95 Area (deg2)
Week 96 (n=2,8,13,1,7)
18.30 degrees squared (deg2)
Standard Deviation 12.563
32.70 degrees squared (deg2)
Standard Deviation 7.495
43.90 degrees squared (deg2)
Standard Deviation 30.123
31.15 degrees squared (deg2)
Standard Deviation 19.152
0.80 degrees squared (deg2)
Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 95 Area (deg2)
Week 144 (n=1,5,8,2,0)
—
36.60 degrees squared (deg2)
56.32 degrees squared (deg2)
Standard Deviation 55.119
39.13 degrees squared (deg2)
Standard Deviation 22.511
12.85 degrees squared (deg2)
Standard Deviation 15.768
Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 95 Area (deg2)
Week 192 (1,2,7,0,0)
—
116.40 degrees squared (deg2)
23.15 degrees squared (deg2)
Standard Deviation 0.778
41.33 degrees squared (deg2)
Standard Deviation 25.644
—
Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse Area (BCEA) 95 Area (deg2)
Week 240 (1,1,2,0,0)
—
120.40 degrees squared (deg2)
33.40 degrees squared (deg2)
56.60 degrees squared (deg2)
Standard Deviation 73.115
—

SECONDARY outcome

Timeframe: Up to Week 240

Population: Full Analysis Set - All treated patients with a valid measurement without a protocol deviation with impact

Macular sensitivity as assessed by mesopic Microperimetry

Outcome measures

Outcome measures
Measure
GT005 2E11 vg With Orbit Subretinal Delivery System
n=11 Participants
GT005 2E11 vg with Orbit Subretinal Delivery System
GT005 2E10 vg Via Transvitreal Procedure
n=3 Participants
GT005 2E10 vg via Transvitreal Procedure
GT005 5E10 vg Via Transvitreal Procedure
n=9 Participants
GT005 5E10 vg via Transvitreal Procedure
GT005 2E11 vg Via Transvitreal Procedure
n=14 Participants
GT005 2E11 vg via Transvitreal Procedure
GT005 5E10 vg With Orbit Subretinal Delivery System
n=3 Participants
GT005 5E10 vg with Orbit Subretinal Delivery System
Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Mean Sensitivity Decibel (dB)
Week 72 (n=1,8,13,2,10)
11.80 Decibel (dB)
Standard Deviation 3.435
13.00 Decibel (dB)
6.89 Decibel (dB)
Standard Deviation 6.163
8.93 Decibel (dB)
Standard Deviation 5.416
8.55 Decibel (dB)
Standard Deviation 3.748
Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Mean Sensitivity Decibel (dB)
Week 96 (n=2,8,13,1,7)
11.19 Decibel (dB)
Standard Deviation 4.245
8.70 Decibel (dB)
Standard Deviation 2.687
6.06 Decibel (dB)
Standard Deviation 6.283
8.54 Decibel (dB)
Standard Deviation 4.859
10.20 Decibel (dB)
Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Mean Sensitivity Decibel (dB)
Week 144 (n=1,5,8,2,0)
—
4.00 Decibel (dB)
7.52 Decibel (dB)
Standard Deviation 6.222
9.58 Decibel (dB)
Standard Deviation 6.123
12.45 Decibel (dB)
Standard Deviation 4.313
Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Mean Sensitivity Decibel (dB)
Week 192 (1,2,7,0,0)
—
3.90 Decibel (dB)
6.45 Decibel (dB)
Standard Deviation 5.728
6.87 Decibel (dB)
Standard Deviation 6.145
—
Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Mean Sensitivity Decibel (dB)
Week 240 (1,1,2,0,0)
—
1.40 Decibel (dB)
1.70 Decibel (dB)
7.85 Decibel (dB)
Standard Deviation 6.435
—
Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Mean Sensitivity Decibel (dB)
Week 12 (n=2,9,11,1,10)
13.51 Decibel (dB)
Standard Deviation 3.350
14.30 Decibel (dB)
Standard Deviation 2.121
7.76 Decibel (dB)
Standard Deviation 5.536
11.92 Decibel (dB)
Standard Deviation 5.165
0.90 Decibel (dB)
Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Mean Sensitivity Decibel (dB)
Week 24 (n=3,9,10,3,11)
13.02 Decibel (dB)
Standard Deviation 4.125
4.20 Decibel (dB)
Standard Deviation 3.704
7.31 Decibel (dB)
Standard Deviation 5.736
10.63 Decibel (dB)
Standard Deviation 5.263
9.17 Decibel (dB)
Standard Deviation 8.259
Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Mean Sensitivity Decibel (dB)
Week 48 (n=2,9,14,2,10)
12.19 Decibel (dB)
Standard Deviation 5.096
5.75 Decibel (dB)
Standard Deviation 0.354
6.71 Decibel (dB)
Standard Deviation 6.065
9.96 Decibel (dB)
Standard Deviation 4.726
10.50 Decibel (dB)
Standard Deviation 4.525

SECONDARY outcome

Timeframe: Up to Week 240

Population: Full Analysis Set - All treated patients with a valid measurement without a protocol deviation with impact

Macular sensitivity as assessed by mesopic Microperimetry

Outcome measures

Outcome measures
Measure
GT005 2E11 vg With Orbit Subretinal Delivery System
n=11 Participants
GT005 2E11 vg with Orbit Subretinal Delivery System
GT005 2E10 vg Via Transvitreal Procedure
n=3 Participants
GT005 2E10 vg via Transvitreal Procedure
GT005 5E10 vg Via Transvitreal Procedure
n=9 Participants
GT005 5E10 vg via Transvitreal Procedure
GT005 2E11 vg Via Transvitreal Procedure
n=14 Participants
GT005 2E11 vg via Transvitreal Procedure
GT005 5E10 vg With Orbit Subretinal Delivery System
n=3 Participants
GT005 5E10 vg with Orbit Subretinal Delivery System
Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Number of Scotomatous Points
Week 12 (n=2,9,11,1,10)
11.9 MP Number of Scotomatous Points
Standard Deviation 4.75
6.0 MP Number of Scotomatous Points
Standard Deviation 0.00
29.3 MP Number of Scotomatous Points
Standard Deviation 13.13
20.4 MP Number of Scotomatous Points
Standard Deviation 12.78
44.0 MP Number of Scotomatous Points
Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Number of Scotomatous Points
Week 24 (n=3,9,10,3,11)
12.5 MP Number of Scotomatous Points
Standard Deviation 5.87
44.3 MP Number of Scotomatous Points
Standard Deviation 14.01
30.8 MP Number of Scotomatous Points
Standard Deviation 13.15
23.6 MP Number of Scotomatous Points
Standard Deviation 12.76
21.0 MP Number of Scotomatous Points
Standard Deviation 22.52
Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Number of Scotomatous Points
Week 48 (n=2,9,14,2,10)
15.0 MP Number of Scotomatous Points
Standard Deviation 7.77
40.0 MP Number of Scotomatous Points
Standard Deviation 1.41
34.2 MP Number of Scotomatous Points
Standard Deviation 15.08
22.0 MP Number of Scotomatous Points
Standard Deviation 11.73
16.5 MP Number of Scotomatous Points
Standard Deviation 7.78
Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Number of Scotomatous Points
Week 72 (n=1,8,13,2,10)
15.9 MP Number of Scotomatous Points
Standard Deviation 7.37
9.0 MP Number of Scotomatous Points
35.0 MP Number of Scotomatous Points
Standard Deviation 15.07
24.7 MP Number of Scotomatous Points
Standard Deviation 12.30
19.5 MP Number of Scotomatous Points
Standard Deviation 9.19
Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Number of Scotomatous Points
Week 96 (n=2,8,13,1,7)
17.0 MP Number of Scotomatous Points
Standard Deviation 4.86
26.0 MP Number of Scotomatous Points
Standard Deviation 18.38
36.4 MP Number of Scotomatous Points
Standard Deviation 16.09
27.5 MP Number of Scotomatous Points
Standard Deviation 13.33
17.0 MP Number of Scotomatous Points
Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Number of Scotomatous Points
Week 144 (n=1,5,8,2,0)
—
44.0 MP Number of Scotomatous Points
32.2 MP Number of Scotomatous Points
Standard Deviation 16.93
27.6 MP Number of Scotomatous Points
Standard Deviation 15.82
17.0 MP Number of Scotomatous Points
Standard Deviation 9.90
Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Number of Scotomatous Points
Week 192 (1,2,7,0,0)
—
40.0 MP Number of Scotomatous Points
37.0 MP Number of Scotomatous Points
Standard Deviation 22.63
32.4 MP Number of Scotomatous Points
Standard Deviation 18.12
—
Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Number of Scotomatous Points
Week 240 (1,1,2,0,0)
—
46.0 MP Number of Scotomatous Points
50.0 MP Number of Scotomatous Points
33.0 MP Number of Scotomatous Points
Standard Deviation 16.97
—

SECONDARY outcome

Timeframe: Up to Week 240

Population: Full Analysis Set - All treated patients with a valid measurement without a protocol deviation with impact

Macular sensitivity as assessed by mesopic Microperimetry

Outcome measures

Outcome measures
Measure
GT005 2E11 vg With Orbit Subretinal Delivery System
n=11 Participants
GT005 2E11 vg with Orbit Subretinal Delivery System
GT005 2E10 vg Via Transvitreal Procedure
n=3 Participants
GT005 2E10 vg via Transvitreal Procedure
GT005 5E10 vg Via Transvitreal Procedure
n=9 Participants
GT005 5E10 vg via Transvitreal Procedure
GT005 2E11 vg Via Transvitreal Procedure
n=14 Participants
GT005 2E11 vg via Transvitreal Procedure
GT005 5E10 vg With Orbit Subretinal Delivery System
n=3 Participants
GT005 5E10 vg with Orbit Subretinal Delivery System
Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Percent Fixation Loss (%)
Week 12 (n=2,9,11,1,10)
5.5 MP Percent Fixation Loss (%)
Standard Deviation 7.11
4.0 MP Percent Fixation Loss (%)
Standard Deviation 5.66
9.8 MP Percent Fixation Loss (%)
Standard Deviation 13.92
6.9 MP Percent Fixation Loss (%)
Standard Deviation 8.69
0.0 MP Percent Fixation Loss (%)
Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Percent Fixation Loss (%)
Week 24 (n=3,9,10,3,11)
11.3 MP Percent Fixation Loss (%)
Standard Deviation 8.60
0.0 MP Percent Fixation Loss (%)
Standard Deviation 0.00
9.3 MP Percent Fixation Loss (%)
Standard Deviation 17.00
6.4 MP Percent Fixation Loss (%)
Standard Deviation 9.00
0.0 MP Percent Fixation Loss (%)
Standard Deviation 0.00
Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Percent Fixation Loss (%)
Week 48 (n=2,9,14,2,10)
4.6 MP Percent Fixation Loss (%)
Standard Deviation 6.19
0.0 MP Percent Fixation Loss (%)
Standard Deviation 0.00
3.8 MP Percent Fixation Loss (%)
Standard Deviation 7.64
10.5 MP Percent Fixation Loss (%)
Standard Deviation 23.45
0.0 MP Percent Fixation Loss (%)
Standard Deviation 0.00
Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Percent Fixation Loss (%)
Week 72 (n=1,8,13,2,10)
6.2 MP Percent Fixation Loss (%)
Standard Deviation 8.52
13.0 MP Percent Fixation Loss (%)
1.8 MP Percent Fixation Loss (%)
Standard Deviation 4.95
12.0 MP Percent Fixation Loss (%)
Standard Deviation 25.31
4.0 MP Percent Fixation Loss (%)
Standard Deviation 5.66
Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Percent Fixation Loss (%)
Week 96 (n=2,8,13,1,7)
7.6 MP Percent Fixation Loss (%)
Standard Deviation 11.07
8.5 MP Percent Fixation Loss (%)
Standard Deviation 12.02
6.5 MP Percent Fixation Loss (%)
Standard Deviation 9.65
10.3 MP Percent Fixation Loss (%)
Standard Deviation 9.06
0.0 MP Percent Fixation Loss (%)
Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Percent Fixation Loss (%)
Week 144 (n=1,5,8,2,0)
—
0.0 MP Percent Fixation Loss (%)
0.0 MP Percent Fixation Loss (%)
Standard Deviation 0.00
4.4 MP Percent Fixation Loss (%)
Standard Deviation 8.11
6.5 MP Percent Fixation Loss (%)
Standard Deviation 9.19
Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Percent Fixation Loss (%)
Week 192 (1,2,7,0,0)
—
0.0 MP Percent Fixation Loss (%)
0.0 MP Percent Fixation Loss (%)
Standard Deviation 0.00
1.7 MP Percent Fixation Loss (%)
Standard Deviation 5.38
—
Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Percent Fixation Loss (%)
Week 240 (1,1,2,0,0)
—
0.0 MP Percent Fixation Loss (%)
0.0 MP Percent Fixation Loss (%)
0.0 MP Percent Fixation Loss (%)
Standard Deviation 0.00
—

SECONDARY outcome

Timeframe: Up to Week 240

Population: Full Analysis Set - for patients with a valid measurement without a protocol deviation with impact

Change from baseline in GA size as assessed by fundus autofluorescence

Outcome measures

Outcome measures
Measure
GT005 2E11 vg With Orbit Subretinal Delivery System
n=21 Participants
GT005 2E11 vg with Orbit Subretinal Delivery System
GT005 2E10 vg Via Transvitreal Procedure
n=6 Participants
GT005 2E10 vg via Transvitreal Procedure
GT005 5E10 vg Via Transvitreal Procedure
n=10 Participants
GT005 5E10 vg via Transvitreal Procedure
GT005 2E11 vg Via Transvitreal Procedure
n=15 Participants
GT005 2E11 vg via Transvitreal Procedure
GT005 5E10 vg With Orbit Subretinal Delivery System
n=3 Participants
GT005 5E10 vg with Orbit Subretinal Delivery System
Change From Baseline Over Time in Square Root of Geographic Atrophy Area Size (mm) Via FAF in the Study Eye
Week 5 (n=6,10,13,3,20)
0.08 mm
Standard Deviation 0.064
0.06 mm
Standard Deviation 0.081
0.06 mm
Standard Deviation 0.028
0.06 mm
Standard Deviation 0.045
0.17 mm
Standard Deviation 0.147
Change From Baseline Over Time in Square Root of Geographic Atrophy Area Size (mm) Via FAF in the Study Eye
Week 12 (n=6,10,10,3,21)
0.15 mm
Standard Deviation 0.096
0.13 mm
Standard Deviation 0.105
0.09 mm
Standard Deviation 0.037
0.12 mm
Standard Deviation 0.061
0.26 mm
Standard Deviation 0.223
Change From Baseline Over Time in Square Root of Geographic Atrophy Area Size (mm) Via FAF in the Study Eye
Week 24 (n=6,10,13,3,19)
0.22 mm
Standard Deviation 0.111
0.20 mm
Standard Deviation 0.161
0.13 mm
Standard Deviation 0.053
0.22 mm
Standard Deviation 0.109
0.37 mm
Standard Deviation 0.296
Change From Baseline Over Time in Square Root of Geographic Atrophy Area Size (mm) Via FAF in the Study Eye
Week 36 (n=5,5,15,3,19)
0.29 mm
Standard Deviation 0.130
0.38 mm
Standard Deviation 0.232
0.18 mm
Standard Deviation 0.098
0.25 mm
Standard Deviation 0.101
0.40 mm
Standard Deviation 0.310
Change From Baseline Over Time in Square Root of Geographic Atrophy Area Size (mm) Via FAF in the Study Eye
Week 48 (n=5,9,13,3,21)
0.35 mm
Standard Deviation 0.155
0.57 mm
Standard Deviation 0.259
0.23 mm
Standard Deviation 0.105
0.30 mm
Standard Deviation 0.118
0.48 mm
Standard Deviation 0.384
Change From Baseline Over Time in Square Root of Geographic Atrophy Area Size (mm) Via FAF in the Study Eye
Week 72 (n=3,8,14,3,17)
0.50 mm
Standard Deviation 0.247
0.57 mm
Standard Deviation 0.374
0.27 mm
Standard Deviation 0.090
0.43 mm
Standard Deviation 0.214
0.57 mm
Standard Deviation 0.425
Change From Baseline Over Time in Square Root of Geographic Atrophy Area Size (mm) Via FAF in the Study Eye
Week 96 (n=4,8,13,2,18)
0.60 mm
Standard Deviation 0.282
0.59 mm
Standard Deviation 0.424
0.33 mm
Standard Deviation 0.113
0.54 mm
Standard Deviation 0.246
0.70 mm
Standard Deviation 0.822
Change From Baseline Over Time in Square Root of Geographic Atrophy Area Size (mm) Via FAF in the Study Eye
Week 144 (n=2,6,8,3,2)
0.98 mm
Standard Deviation 0.144
0.62 mm
Standard Deviation 0.137
0.42 mm
Standard Deviation 0.081
0.77 mm
Standard Deviation 0.329
0.99 mm
Standard Deviation 0.790
Change From Baseline Over Time in Square Root of Geographic Atrophy Area Size (mm) Via FAF in the Study Eye
Week 192 (n=2,2,5,0,0)
—
0.89 mm
Standard Deviation 0.112
0.46 mm
Standard Deviation 0.042
0.89 mm
Standard Deviation 0.346
—
Change From Baseline Over Time in Square Root of Geographic Atrophy Area Size (mm) Via FAF in the Study Eye
Week 240 (n=2,0,2,0,0)
—
1.07 mm
Standard Deviation 0.216
—
1.07 mm
Standard Deviation 0.007
—

SECONDARY outcome

Timeframe: Day 1

Population: All Enrolled Set - For the 28 participants in the US where the Orbit Subretinal Delivery System was attempted. 34 devices were used for 28 total pts - some deliveries took more than 1 attempt before the delivery was successful. If a delivery failed, a new attempt with a new device was conducted. The arms for this endpoint are combined per the SAP, because the endpoint is independent of the dose; only the attempted and successful delivery via the Orbit SDS device is of relevance.

The rate of successful delivery is an evaluation limited to the administration performed using the Orbit Subretinal Delivery System (SDS) device, which is a 510(k) cleared device in the US. The rate of successful delivery of GT005 is the number of full doses delivered divided by number of Orbit devices used. This endpoint evaluates the surgical procedure with the Orbit device, and it is independent of the dose administered, as the volume of GT005 administered was consistent across all arms and cohorts. The delivery was attempted in 28 pts but was only successful in 25 pts. Of 3 pts where the GT005 delivery via Orbit SDS arms was not successful, 2 were treated via the transvitreal procedure, and 1 was disc. from treatment. (For 1 of the 3 pts, BSS delivery was successful, but not GT005 delivery.) In all other efficacy tables, these 2 pts who were treated via the transvitreal procedure are included in the 1 of the 3 Transvitreal Procedure arms and not 1 of the 2 Orbit SDS arms.

Outcome measures

Outcome measures
Measure
GT005 2E11 vg With Orbit Subretinal Delivery System
GT005 2E11 vg with Orbit Subretinal Delivery System
GT005 2E10 vg Via Transvitreal Procedure
n=34 Orbit devices
GT005 2E10 vg via Transvitreal Procedure
GT005 5E10 vg Via Transvitreal Procedure
GT005 5E10 vg via Transvitreal Procedure
GT005 2E11 vg Via Transvitreal Procedure
GT005 2E11 vg via Transvitreal Procedure
GT005 5E10 vg With Orbit Subretinal Delivery System
GT005 5E10 vg with Orbit Subretinal Delivery System
Delivery of GT005 to the Subretinal Space - Rate of Successful Delivery, % (US Only) Via the Orbit Subretinal Delivery System (SDS) Device
—
70.6 percent of devices
—
—
—

SECONDARY outcome

Timeframe: Day 1

Population: All Enrolled Set - For the 28 participants in the US where the Orbit Subretinal Delivery System was attempted. 34 devices were used for 28 total pts - some deliveries took more than 1 attempt before the delivery was successful. If a delivery failed, a new attempt with a new device was conducted. The arms for this endpoint are combined per the SAP, because the endpoint is independent of the dose; only the attempted and successful delivery via the Orbit SDS device is of relevance.

The rate of successful delivery is an evaluation limited to the administration performed using the Orbit Subretinal Delivery System (SDS) device, which is a 510(k) cleared device in the US. The rate of successful delivery of BSS was the number of full doses delivered divided by number of Orbit devices used. This endpoint evaluates the surgical procedure with the Orbit device, and it is independent of the dose administered, as the volume of BSS administered was consistent across all arms and cohorts. The delivery was attempted in 28 pts but was only successful in 25 pts. Of 3 pts where the GT005 delivery via Orbit SDS arms was not successful, 2 were treated via the transvitreal procedure, and 1 was disc. from treatment. (For 1 of the 3 pts, BSS delivery was successful, but not GT005 delivery.) In all other efficacy tables, these 2 pts who were treated via the transvitreal procedure are included in the 1 of the 3 Transvitreal Procedure arms and not 1 of the 2 Orbit SDS arms.

Outcome measures

Outcome measures
Measure
GT005 2E11 vg With Orbit Subretinal Delivery System
GT005 2E11 vg with Orbit Subretinal Delivery System
GT005 2E10 vg Via Transvitreal Procedure
n=34 Orbit devices
GT005 2E10 vg via Transvitreal Procedure
GT005 5E10 vg Via Transvitreal Procedure
GT005 5E10 vg via Transvitreal Procedure
GT005 2E11 vg Via Transvitreal Procedure
GT005 2E11 vg via Transvitreal Procedure
GT005 5E10 vg With Orbit Subretinal Delivery System
GT005 5E10 vg with Orbit Subretinal Delivery System
Delivery of Balanced Salt Solution (BSS) or BSS PLUS (BSS+) to the Subretinal Space - Rate of Successful Delivery, % (US Only) Via the Orbit Subretinal Delivery System (SDS) Device
—
76.5 percent of devices
—
—
—

SECONDARY outcome

Timeframe: Day 1

Population: Safety Analysis Set - All treated patients

Subjects with device related AEs and SAEs after subretinal delivery with Orbit SDS. An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject. A TEAE is defined as any AE that develops after randomization or any AE already present that worsens following randomization. The primary summaries of AEs are based on TEAEs. System organ classes are sorted alphabetically, and preferred terms are sorted by decreasing overall frequency within system organ class.

Outcome measures

Outcome measures
Measure
GT005 2E11 vg With Orbit Subretinal Delivery System
n=22 Participants
GT005 2E11 vg with Orbit Subretinal Delivery System
GT005 2E10 vg Via Transvitreal Procedure
n=6 Participants
GT005 2E10 vg via Transvitreal Procedure
GT005 5E10 vg Via Transvitreal Procedure
n=10 Participants
GT005 5E10 vg via Transvitreal Procedure
GT005 2E11 vg Via Transvitreal Procedure
n=15 Participants
GT005 2E11 vg via Transvitreal Procedure
GT005 5E10 vg With Orbit Subretinal Delivery System
n=3 Participants
GT005 5E10 vg with Orbit Subretinal Delivery System
Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye
Subjects with at least one TEAE Related to Surgical Procedure
20 Participants
2 Participants
4 Participants
9 Participants
3 Participants
Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye
-Conjunctival haemorrhage
14 Participants
0 Participants
0 Participants
0 Participants
3 Participants
Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye
-Eye discharge
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye
-Keratitis
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye
Eye disorders
20 Participants
2 Participants
4 Participants
8 Participants
3 Participants
Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye
-Choroidal haemorrhage
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye
-Choroidal neovascularisation
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye
-Corneal oedema
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye
-Dry eye
0 Participants
1 Participants
0 Participants
0 Participants
0 Participants
Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye
-Eye pain
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye
-Eye pruritus
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye
-Foreign body sensation in eyes
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye
-Iridocyclitis
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye
-Ocular discomfort
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye
-Periorbital oedema
0 Participants
1 Participants
0 Participants
0 Participants
0 Participants
Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye
Injury, poisoning and procedural complications
3 Participants
0 Participants
0 Participants
2 Participants
0 Participants
Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye
-Corneal abrasion
1 Participants
0 Participants
0 Participants
1 Participants
0 Participants
Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye
-Post procedural discomfort
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye
-Procedural pain
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye
-Suture related complication
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye
Investigations
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye
-Intraocular pressure increased
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye
-Cataract
0 Participants
1 Participants
3 Participants
7 Participants
0 Participants
Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye
-Retinal pigmentation
6 Participants
0 Participants
2 Participants
2 Participants
0 Participants
Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye
-Retinal haemorrhage
3 Participants
0 Participants
1 Participants
1 Participants
3 Participants
Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye
-Anterior chamber cell
3 Participants
0 Participants
0 Participants
1 Participants
1 Participants
Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye
-Conjunctival hyperaemia
2 Participants
0 Participants
0 Participants
1 Participants
0 Participants
Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye
-Retinal tear
3 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye
-Vitreous floaters
0 Participants
0 Participants
0 Participants
1 Participants
1 Participants

SECONDARY outcome

Timeframe: Day 1

Population: Safety Analysis Set - All treated patients

Subjects with device related AEs and SAEs after subretinal delivery with Orbit SDS. An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject. A TEAE is defined as any AE that develops after randomization or any AE already present that worsens following randomization. The primary summaries of AEs are based on TEAEs. System organ classes are sorted alphabetically, and preferred terms are sorted by decreasing overall frequency within system organ class.

Outcome measures

Outcome measures
Measure
GT005 2E11 vg With Orbit Subretinal Delivery System
n=22 Participants
GT005 2E11 vg with Orbit Subretinal Delivery System
GT005 2E10 vg Via Transvitreal Procedure
n=6 Participants
GT005 2E10 vg via Transvitreal Procedure
GT005 5E10 vg Via Transvitreal Procedure
n=10 Participants
GT005 5E10 vg via Transvitreal Procedure
GT005 2E11 vg Via Transvitreal Procedure
n=15 Participants
GT005 2E11 vg via Transvitreal Procedure
GT005 5E10 vg With Orbit Subretinal Delivery System
n=3 Participants
GT005 5E10 vg with Orbit Subretinal Delivery System
Summary of Non-Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants

SECONDARY outcome

Timeframe: Day 1

Population: Safety Analysis Set - All treated patients

Subjects with device related AEs and SAEs after subretinal delivery with Orbit SDS. An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject. A TEAE is defined as any AE that develops after randomization or any AE already present that worsens following randomization. The primary summaries of AEs are based on TEAEs. System organ classes are sorted alphabetically, and preferred terms are sorted by decreasing overall frequency within system organ class.

Outcome measures

Outcome measures
Measure
GT005 2E11 vg With Orbit Subretinal Delivery System
n=22 Participants
GT005 2E11 vg with Orbit Subretinal Delivery System
GT005 2E10 vg Via Transvitreal Procedure
n=6 Participants
GT005 2E10 vg via Transvitreal Procedure
GT005 5E10 vg Via Transvitreal Procedure
n=10 Participants
GT005 5E10 vg via Transvitreal Procedure
GT005 2E11 vg Via Transvitreal Procedure
n=15 Participants
GT005 2E11 vg via Transvitreal Procedure
GT005 5E10 vg With Orbit Subretinal Delivery System
n=3 Participants
GT005 5E10 vg with Orbit Subretinal Delivery System
Summary of Ocular Serious Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants

SECONDARY outcome

Timeframe: Day 1

Population: Safety Analysis Set - All treated patients

Subjects with device related AEs and SAEs after subretinal delivery with Orbit SDS. An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject. A TEAE is defined as any AE that develops after randomization or any AE already present that worsens following randomization. The primary summaries of AEs are based on TEAEs. System organ classes are sorted alphabetically, and preferred terms are sorted by decreasing overall frequency within system organ class.

Outcome measures

Outcome measures
Measure
GT005 2E11 vg With Orbit Subretinal Delivery System
n=22 Participants
GT005 2E11 vg with Orbit Subretinal Delivery System
GT005 2E10 vg Via Transvitreal Procedure
n=6 Participants
GT005 2E10 vg via Transvitreal Procedure
GT005 5E10 vg Via Transvitreal Procedure
n=10 Participants
GT005 5E10 vg via Transvitreal Procedure
GT005 2E11 vg Via Transvitreal Procedure
n=15 Participants
GT005 2E11 vg via Transvitreal Procedure
GT005 5E10 vg With Orbit Subretinal Delivery System
n=3 Participants
GT005 5E10 vg with Orbit Subretinal Delivery System
Summary of Non-Ocular Serious Treatment-Emergent Adverse Events Related to Surgical Procedure
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants

Adverse Events

GT005 2E10 vg Via Transvitreal Procedure

Serious events: 2 serious events
Other events: 4 other events
Deaths: 1 deaths

GT005 5E10 vg Via Transvitreal Procedure

Serious events: 6 serious events
Other events: 10 other events
Deaths: 3 deaths

GT005 2E11 vg Via Transvitreal Procedure

Serious events: 4 serious events
Other events: 15 other events
Deaths: 0 deaths

GT005 5E10 vg With Orbit Subretinal Delivery System

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

GT005 2E11 vg With Orbit Subretinal Delivery System

Serious events: 5 serious events
Other events: 22 other events
Deaths: 0 deaths

Overall

Serious events: 17 serious events
Other events: 54 other events
Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure
GT005 2E10 vg Via Transvitreal Procedure
n=6 participants at risk
GT005 2E10 vg via Transvitreal Procedure
GT005 5E10 vg Via Transvitreal Procedure
n=10 participants at risk
GT005 5E10 vg via Transvitreal Procedure
GT005 2E11 vg Via Transvitreal Procedure
n=15 participants at risk
GT005 2E11 vg via Transvitreal Procedure
GT005 5E10 vg With Orbit Subretinal Delivery System
n=3 participants at risk
GT005 5E10 vg with Orbit Subretinal Delivery System
GT005 2E11 vg With Orbit Subretinal Delivery System
n=22 participants at risk
GT005 2E11 vg with Orbit Subretinal Delivery System
Overall
n=56 participants at risk
Overall
Cardiac disorders
Acute myocardial infarction
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Cardiac disorders
Atrial fibrillation
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Cardiac disorders
Bradycardia
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Cardiac disorders
Cardiac failure congestive
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Cardiac disorders
Pericardial effusion
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Cardiac disorders
Ventricular tachycardia
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Gastrointestinal disorders
Haematemesis
16.7%
1/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Gastrointestinal disorders
Inguinal hernia
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Hepatobiliary disorders
Cholangitis
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Infections and infestations
COVID-19
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Infections and infestations
Cellulitis
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
3.6%
2/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Infections and infestations
Lower respiratory tract infection
16.7%
1/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
3.6%
2/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Infections and infestations
Pneumonia
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Infections and infestations
Pneumonia aspiration
16.7%
1/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Infections and infestations
Septic shock
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Infections and infestations
Staphylococcal infection
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Injury, poisoning and procedural complications
Fall
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
13.3%
2/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
3.6%
2/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Injury, poisoning and procedural complications
Femoral neck fracture
16.7%
1/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
3.6%
2/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Injury, poisoning and procedural complications
Joint dislocation
16.7%
1/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Injury, poisoning and procedural complications
Rib fracture
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Injury, poisoning and procedural complications
Subdural haemorrhage
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphatic system neoplasm
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Nervous system disorders
Cerebral haemorrhage
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Nervous system disorders
Cerebrovascular accident
16.7%
1/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
3.6%
2/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Nervous system disorders
Presyncope
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Nervous system disorders
Syncope
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Respiratory, thoracic and mediastinal disorders
Pleural effusion
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Vascular disorders
Deep vein thrombosis
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Vascular disorders
Peripheral artery aneurysm
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.

Other adverse events

Other adverse events
Measure
GT005 2E10 vg Via Transvitreal Procedure
n=6 participants at risk
GT005 2E10 vg via Transvitreal Procedure
GT005 5E10 vg Via Transvitreal Procedure
n=10 participants at risk
GT005 5E10 vg via Transvitreal Procedure
GT005 2E11 vg Via Transvitreal Procedure
n=15 participants at risk
GT005 2E11 vg via Transvitreal Procedure
GT005 5E10 vg With Orbit Subretinal Delivery System
n=3 participants at risk
GT005 5E10 vg with Orbit Subretinal Delivery System
GT005 2E11 vg With Orbit Subretinal Delivery System
n=22 participants at risk
GT005 2E11 vg with Orbit Subretinal Delivery System
Overall
n=56 participants at risk
Overall
Blood and lymphatic system disorders
Anaemia
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Eye disorders
Dry eye - Fellow eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
20.0%
2/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
13.3%
2/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
8.9%
5/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Blood and lymphatic system disorders
Iron deficiency anaemia
16.7%
1/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Blood and lymphatic system disorders
Neutropenia
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Cardiac disorders
Angina pectoris
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Cardiac disorders
Aortic valve incompetence
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Cardiac disorders
Arrhythmia
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Cardiac disorders
Atrial fibrillation
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
3.6%
2/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Cardiac disorders
Bradycardia
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Eye disorders
Dry eye - Study eye
16.7%
1/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
20.0%
2/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
13.3%
2/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
9.1%
2/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
12.5%
7/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Cardiac disorders
Diastolic dysfunction
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Cardiac disorders
Ventricular tachycardia
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Congenital, familial and genetic disorders
Corneal dystrophy - Fellow eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Eye disorders
Conjunctival hyperaemia - Study eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
9.1%
2/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
5.4%
3/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Eye disorders
Corneal oedema - Study eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Eye disorders
Diplopia - Study eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Congenital, familial and genetic disorders
Corneal dystrophy - Study eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Ear and labyrinth disorders
Ear pruritus
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
33.3%
1/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Ear and labyrinth disorders
Vertigo
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Endocrine disorders
Goitre
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Endocrine disorders
Hypothyroidism
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Eye disorders
Anterior chamber cell - Study eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
33.3%
1/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
13.6%
3/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
8.9%
5/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Eye disorders
Blepharitis - Fellow eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
30.0%
3/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
5.4%
3/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Eye disorders
Blepharitis - Study eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
30.0%
3/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
5.4%
3/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Eye disorders
Cataract - Fellow eye
16.7%
1/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
13.3%
2/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
9.1%
2/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.7%
6/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Eye disorders
Cataract - Study eye
16.7%
1/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
30.0%
3/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
46.7%
7/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
9.1%
2/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
23.2%
13/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Eye disorders
Central vision loss - Study eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Eye disorders
Chalazion - Study eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
33.3%
1/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Eye disorders
Charles Bonnet syndrome - Fellow eye
16.7%
1/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
3.6%
2/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Eye disorders
Charles Bonnet syndrome - Study eye
16.7%
1/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
3.6%
2/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Eye disorders
Choroidal haemorrhage - Study eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Eye disorders
Choroidal neovascularisation - Fellow eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Eye disorders
Choroidal neovascularisation - Study eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Eye disorders
Conjunctival deposit - Study eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Eye disorders
Conjunctival haemorrhage - Study eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
100.0%
3/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
68.2%
15/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
32.1%
18/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Eye disorders
Dacryostenosis acquired - Study eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Eye disorders
Diplopia - Fellow eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Eye disorders
Eye discharge - Study eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
33.3%
1/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Eye disorders
Eye pain - Fellow eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Eye disorders
Eye pain - Study eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
3.6%
2/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Eye disorders
Eye pruritus - Study eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Eye disorders
Eyelid irritation - Study eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
33.3%
1/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Eye disorders
Eyelid ptosis - Fellow eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Eye disorders
Eyelid ptosis - Study eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
3.6%
2/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Eye disorders
Foreign body sensation in eyes - Study eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Eye disorders
Glaucoma - Fellow eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Eye disorders
Glaucoma - Study eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Eye disorders
Iridocyclitis - Study eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Eye disorders
Keratitis - Study eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
33.3%
1/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Eye disorders
Macular hole - Study eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Eye disorders
Neovascular age-related macular degeneration - Fellow eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
13.3%
2/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
33.3%
1/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
5.4%
3/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Eye disorders
Neovascular age-related macular degeneration - Study eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
33.3%
1/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
9.1%
2/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
5.4%
3/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Eye disorders
Ocular discomfort - Study eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Eye disorders
Ocular hypertension - Fellow eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Eye disorders
Ocular hypertension - Study eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Eye disorders
Optic disc haemorrhage - Fellow eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Eye disorders
Optic disc haemorrhage - Study eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Eye disorders
Periorbital oedema - Study eye
16.7%
1/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Eye disorders
Posterior capsule opacification - Fellow eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Eye disorders
Posterior capsule opacification - Study eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Eye disorders
Retinal aneurysm rupture - Fellow eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Eye disorders
Retinal depigmentation - Study eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Eye disorders
Retinal haemorrhage - Fellow eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
9.1%
2/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
5.4%
3/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Eye disorders
Retinal haemorrhage - Study eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
20.0%
2/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
100.0%
3/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
22.7%
5/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
19.6%
11/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Eye disorders
Retinal pigmentation - Fellow eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
9.1%
2/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
3.6%
2/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Eye disorders
Retinal pigmentation - Study eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
40.0%
4/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
66.7%
10/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
36.4%
8/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
39.3%
22/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
General disorders
Fatigue
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Eye disorders
Retinal tear - Study eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
18.2%
4/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
7.1%
4/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Eye disorders
Vision blurred - Fellow eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Eye disorders
Vision blurred - Study eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Eye disorders
Visual acuity reduced - Fellow eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
30.0%
3/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
33.3%
1/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
7.1%
4/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Eye disorders
Visual acuity reduced - Study eye
16.7%
1/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
3.6%
2/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Eye disorders
Visual field defect - Fellow eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
13.3%
2/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
3.6%
2/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Eye disorders
Visual field defect - Study eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
20.0%
3/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
5.4%
3/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Eye disorders
Visual impairment - Fellow eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Eye disorders
Visual impairment - Study eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Eye disorders
Vitreous floaters - Study eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
33.3%
1/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
3.6%
2/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Gastrointestinal disorders
Constipation
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
30.0%
3/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
7.1%
4/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Gastrointestinal disorders
Diarrhoea
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Gastrointestinal disorders
Dysphagia
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
20.0%
2/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
5.4%
3/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Gastrointestinal disorders
Gastritis
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Gastrointestinal disorders
Gastrooesophageal reflux disease
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
9.1%
2/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
5.4%
3/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Gastrointestinal disorders
Hiatus hernia
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Gastrointestinal disorders
Intestinal polyp
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Gastrointestinal disorders
Intra-abdominal haematoma
16.7%
1/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Gastrointestinal disorders
Large intestine polyp
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Gastrointestinal disorders
Nausea
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
3.6%
2/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Gastrointestinal disorders
Oesophageal perforation
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Gastrointestinal disorders
Oesophageal stenosis
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Gastrointestinal disorders
Vomiting
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
General disorders
Adverse drug reaction
16.7%
1/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
General disorders
Chest pain
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
General disorders
Hernia
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
General disorders
Oedema
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
General disorders
Oedema peripheral
16.7%
1/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
5.4%
3/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
General disorders
Pain
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
General disorders
Polyp
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
General disorders
Vessel puncture site bruise
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Hepatobiliary disorders
Cholelithiasis
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Hepatobiliary disorders
Hepatic cyst
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Immune system disorders
Drug hypersensitivity
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Infections and infestations
Bronchitis
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Infections and infestations
COVID-19
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
20.0%
2/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
13.3%
2/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
22.7%
5/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
16.1%
9/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Infections and infestations
Cellulitis
16.7%
1/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
5.4%
3/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Infections and infestations
Conjunctivitis - Fellow eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Infections and infestations
Conjunctivitis - Study eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
9.1%
2/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
3.6%
2/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Infections and infestations
Conjunctivitis bacterial - Fellow eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Infections and infestations
Conjunctivitis bacterial - Study eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Infections and infestations
Conjunctivitis viral - Fellow eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
20.0%
2/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
3.6%
2/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Infections and infestations
Conjunctivitis viral - Study eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
20.0%
2/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
3.6%
2/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Infections and infestations
Cystitis
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Infections and infestations
Diverticulitis
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Infections and infestations
Ear infection
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Infections and infestations
Fungal infection
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Infections and infestations
Fungal skin infection
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Infections and infestations
Gastroenteritis bacterial
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Infections and infestations
Herpes zoster
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Infections and infestations
Hordeolum - Fellow eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
3.6%
2/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Infections and infestations
Influenza
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Infections and infestations
Lower respiratory tract infection
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
30.0%
3/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
7.1%
4/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Infections and infestations
Nasopharyngitis
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Infections and infestations
Oral candidiasis
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
3.6%
2/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Infections and infestations
Pharyngitis
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Infections and infestations
Pneumonia
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
3.6%
2/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Infections and infestations
Staphylococcal skin infection
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Infections and infestations
Upper respiratory tract infection
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Infections and infestations
Urinary tract infection
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
20.0%
2/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
13.3%
2/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
7.1%
4/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Infections and infestations
Viral sinusitis
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Infections and infestations
Vulvovaginal mycotic infection
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Injury, poisoning and procedural complications
Arthropod bite
16.7%
1/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Injury, poisoning and procedural complications
Contusion
16.7%
1/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
20.0%
2/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
7.1%
4/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Injury, poisoning and procedural complications
Corneal abrasion - Study eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
3.6%
2/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Injury, poisoning and procedural complications
Eye contusion - Fellow eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Injury, poisoning and procedural complications
Fall
50.0%
3/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
20.0%
2/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
13.3%
2/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
12.5%
7/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Injury, poisoning and procedural complications
Foreign body in eye - Fellow eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Injury, poisoning and procedural complications
Pelvic fracture
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Injury, poisoning and procedural complications
Head injury
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Injury, poisoning and procedural complications
Lumbar vertebral fracture
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Injury, poisoning and procedural complications
Post procedural discomfort - Study eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Injury, poisoning and procedural complications
Procedural pain - Study eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
20.0%
3/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
7.1%
4/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Injury, poisoning and procedural complications
Scrotal haematoma
16.7%
1/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Injury, poisoning and procedural complications
Skin injury
16.7%
1/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Injury, poisoning and procedural complications
Skin laceration
33.3%
2/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
5.4%
3/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Injury, poisoning and procedural complications
Skin wound
16.7%
1/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Injury, poisoning and procedural complications
Suture related complication - Study eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Injury, poisoning and procedural complications
Thermal burn
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Investigations
Alanine aminotransferase increased
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Investigations
Blood albumin decreased
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Investigations
Blood alkaline phosphatase increased
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Investigations
Blood bicarbonate decreased
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Investigations
Blood bilirubin increased
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Investigations
Blood cholesterol increased
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Investigations
Blood creatine phosphokinase increased
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Investigations
Blood folate decreased
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Investigations
Blood glucose increased
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Investigations
Blood lactate dehydrogenase increased
16.7%
1/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Investigations
Blood potassium increased
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Investigations
Blood pressure increased
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Investigations
C-reactive protein increased
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
33.3%
1/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
5.4%
3/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Investigations
Coronavirus test positive
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Investigations
Gamma-glutamyltransferase increased
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Investigations
Haemoglobin decreased
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Investigations
Heart rate irregular
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Investigations
Intraocular pressure increased - Fellow eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
33.3%
1/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
3.6%
2/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Investigations
Intraocular pressure increased - Study eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
33.3%
1/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
5.4%
3/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Investigations
Lipids increased
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Investigations
Liver function test abnormal
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Investigations
Liver function test increased
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Investigations
Neutrophil count increased
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Investigations
Protein C increased
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Investigations
Protein total decreased
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Investigations
Weight decreased
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Investigations
White blood cell count increased
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Metabolism and nutrition disorders
Failure to thrive
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Metabolism and nutrition disorders
Hypercalcaemia
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Metabolism and nutrition disorders
Hyperglycaemia
16.7%
1/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Metabolism and nutrition disorders
Hyperlipidaemia
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Metabolism and nutrition disorders
Hypervolaemia
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Metabolism and nutrition disorders
Hypokalaemia
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Metabolism and nutrition disorders
Iron deficiency
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Metabolism and nutrition disorders
Type 2 diabetes mellitus
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Metabolism and nutrition disorders
Vitamin B12 deficiency
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Metabolism and nutrition disorders
Vitamin D deficiency
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
3.6%
2/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Musculoskeletal and connective tissue disorders
Arthralgia
16.7%
1/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
33.3%
1/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
9.1%
2/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.7%
6/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Musculoskeletal and connective tissue disorders
Back pain
16.7%
1/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Musculoskeletal and connective tissue disorders
Exostosis
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Musculoskeletal and connective tissue disorders
Groin pain
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Musculoskeletal and connective tissue disorders
Joint swelling
16.7%
1/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Musculoskeletal and connective tissue disorders
Muscle spasms
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Musculoskeletal and connective tissue disorders
Myalgia
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Musculoskeletal and connective tissue disorders
Osteoarthritis
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Musculoskeletal and connective tissue disorders
Pain in extremity
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Musculoskeletal and connective tissue disorders
Pathological fracture
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Musculoskeletal and connective tissue disorders
Spinal stenosis
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Nervous system disorders
Headache
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
33.3%
1/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
3.6%
2/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Musculoskeletal and connective tissue disorders
Tendonitis
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Musculoskeletal and connective tissue disorders
Trigger finger
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenoma benign
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
3.6%
2/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Keratoacanthoma
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sweat gland tumour
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Nervous system disorders
Aphasia
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Nervous system disorders
Carotid artery stenosis
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Nervous system disorders
Cerebral artery thrombosis
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Nervous system disorders
Cluster headache
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Nervous system disorders
Dementia
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Nervous system disorders
Dizziness
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Nervous system disorders
Meralgia paraesthetica
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Nervous system disorders
Ophthalmic migraine - Fellow eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
33.3%
1/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Nervous system disorders
Ophthalmic migraine - Study eye
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
33.3%
1/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Nervous system disorders
Post herpetic neuralgia
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Nervous system disorders
Transient ischaemic attack
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Nervous system disorders
Vertebral artery occlusion
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Psychiatric disorders
Anxiety
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Psychiatric disorders
Confusional state
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Psychiatric disorders
Hallucination
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Renal and urinary disorders
Acute kidney injury
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
3.6%
2/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Renal and urinary disorders
Chronic kidney disease
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
20.0%
3/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
5.4%
3/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Renal and urinary disorders
Haematuria
16.7%
1/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Renal and urinary disorders
Nephrolithiasis
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Reproductive system and breast disorders
Breast mass
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Respiratory, thoracic and mediastinal disorders
Asthma
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
3.6%
2/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Respiratory, thoracic and mediastinal disorders
Cough
16.7%
1/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
5.4%
3/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Respiratory, thoracic and mediastinal disorders
Haemoptysis
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Respiratory, thoracic and mediastinal disorders
Sinus congestion
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Skin and subcutaneous tissue disorders
Decubitus ulcer
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
20.0%
2/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
3.6%
2/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Skin and subcutaneous tissue disorders
Dermatitis
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Skin and subcutaneous tissue disorders
Dry skin
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Skin and subcutaneous tissue disorders
Haemosiderin stain
16.7%
1/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Skin and subcutaneous tissue disorders
Hyperkeratosis
16.7%
1/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
3.6%
2/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Skin and subcutaneous tissue disorders
Night sweats
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Skin and subcutaneous tissue disorders
Panniculitis
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Skin and subcutaneous tissue disorders
Precancerous skin lesion
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Skin and subcutaneous tissue disorders
Rosacea
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Skin and subcutaneous tissue disorders
Skin lesion
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
3.6%
2/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Skin and subcutaneous tissue disorders
Skin ulcer
16.7%
1/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Skin and subcutaneous tissue disorders
Stasis dermatitis
16.7%
1/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Vascular disorders
Aortic stenosis
16.7%
1/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Vascular disorders
Hypertension
33.3%
2/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
9.1%
2/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
8.9%
5/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Vascular disorders
Hypertensive emergency
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Vascular disorders
Hypotension
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Vascular disorders
Lymphoedema
16.7%
1/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Vascular disorders
Orthostatic hypotension
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
10.0%
1/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
6.7%
1/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
3.6%
2/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Vascular disorders
Poor peripheral circulation
0.00%
0/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
4.5%
1/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Vascular disorders
Vein disorder
16.7%
1/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Vascular disorders
Venous hypertension
16.7%
1/6 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/10 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/15 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/3 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
0.00%
0/22 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
1.8%
1/56 • Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: + 1 862 778 8300

Results disclosure agreements

  • Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
  • Publication restrictions are in place

Restriction type: OTHER