Trial Outcomes & Findings for A Study of Abicipar Pegol in Japanese Patients With Neovascular Age-related Macular Degeneration (NCT NCT02181504)
NCT ID: NCT02181504
Last Updated: 2017-04-25
Results Overview
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase (positive number change from baseline) in the number of letters read correctly means that vision has improved and a decrease (negative number change from baseline) in the number of letters read correctly means that vision has worsened.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
Baseline, Week 16
Results posted on
2017-04-25
Participant Flow
Participant milestones
| Measure |
Abicipar Pegol 2 mg
Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
|
Abicipar Pegol 1 mg
Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
|
Ranibizumab 0.5 mg
Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
5
|
|
Overall Study
COMPLETED
|
9
|
9
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
Reasons for withdrawal
| Measure |
Abicipar Pegol 2 mg
Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
|
Abicipar Pegol 1 mg
Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
|
Ranibizumab 0.5 mg
Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
1
|
Baseline Characteristics
A Study of Abicipar Pegol in Japanese Patients With Neovascular Age-related Macular Degeneration
Baseline characteristics by cohort
| Measure |
Abicipar Pegol 2 mg
n=10 Participants
Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
|
Abicipar Pegol 1 mg
n=10 Participants
Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
|
Ranibizumab 0.5 mg
n=5 Participants
Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
71.8 Years
STANDARD_DEVIATION 5.75 • n=5 Participants
|
75.6 Years
STANDARD_DEVIATION 7.18 • n=7 Participants
|
76.6 Years
STANDARD_DEVIATION 9.24 • n=5 Participants
|
74.3 Years
STANDARD_DEVIATION 7.10 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 16Population: Modified Intent-to-Treat: all randomized and treated patients with at least 1 follow-up visit
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase (positive number change from baseline) in the number of letters read correctly means that vision has improved and a decrease (negative number change from baseline) in the number of letters read correctly means that vision has worsened.
Outcome measures
| Measure |
Abicipar Pegol 2 mg
n=10 Participants
Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
|
Abicipar Pegol 1 mg
n=10 Participants
Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
|
Ranibizumab 0.5 mg
n=5 Participants
Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
|
|---|---|---|---|
|
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
Baseline
|
58.5 Letters
Standard Deviation 17.30
|
54.3 Letters
Standard Deviation 15.58
|
55.8 Letters
Standard Deviation 9.68
|
|
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
Change from Baseline at Week 16
|
8.9 Letters
Standard Deviation 9.16
|
7.8 Letters
Standard Deviation 8.51
|
17.4 Letters
Standard Deviation 8.08
|
SECONDARY outcome
Timeframe: Baseline, Week 20Population: Modified Intent-to-Treat: all randomized and treated patients with at least 1 follow-up visit
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase (positive number change from baseline) in the number of letters read correctly means that vision has improved and a decrease (negative number change from baseline) in the number of letters read correctly means that vision has worsened.
Outcome measures
| Measure |
Abicipar Pegol 2 mg
n=10 Participants
Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
|
Abicipar Pegol 1 mg
n=10 Participants
Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
|
Ranibizumab 0.5 mg
n=5 Participants
Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
|
|---|---|---|---|
|
Change From Baseline in BCVA in the Study Eye
Baseline
|
58.5 Letters
Standard Deviation 17.30
|
54.3 Letters
Standard Deviation 15.58
|
55.8 Letters
Standard Deviation 9.68
|
|
Change From Baseline in BCVA in the Study Eye
Change from Baseline at Week 20
|
9.6 Letters
Standard Deviation 6.75
|
8.7 Letters
Standard Deviation 7.33
|
17.2 Letters
Standard Deviation 7.73
|
SECONDARY outcome
Timeframe: Baseline, 20 WeeksPopulation: Modified Intent-to-Treat: all randomized and treated patients with at least 1 follow-up visit
BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The percentage of patients with a BCVA gain of ≥15 letters are noted.
Outcome measures
| Measure |
Abicipar Pegol 2 mg
n=10 Participants
Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
|
Abicipar Pegol 1 mg
n=10 Participants
Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
|
Ranibizumab 0.5 mg
n=5 Participants
Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
|
|---|---|---|---|
|
Percentage of Patients With a BCVA Gain of ≥15 Letters in the Study Eye on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale
|
20.0 Percentage of Patients
|
30.0 Percentage of Patients
|
60.0 Percentage of Patients
|
SECONDARY outcome
Timeframe: Baseline, 20 WeeksPopulation: Modified Intent-to-Treat: all randomized and treated patients with at least 1 follow-up visit
BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The percentage of patients with a BCVA gain of ≥10 letters are noted.
Outcome measures
| Measure |
Abicipar Pegol 2 mg
n=10 Participants
Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
|
Abicipar Pegol 1 mg
n=10 Participants
Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
|
Ranibizumab 0.5 mg
n=5 Participants
Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
|
|---|---|---|---|
|
Percentage of Patients With a BCVA Gain of ≥10 Letters in the Study Eye on the ETDRS Scale
|
50.0 Percentage of Patients
|
50.0 Percentage of Patients
|
80.0 Percentage of Patients
|
SECONDARY outcome
Timeframe: Baseline, Week 16, Week 20Population: Modified Intent-to-Treat: all randomized and treated patients with at least 1 follow-up visit
CRT is assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system that provides high-resolution imaging sections of the retina. SD-OCT is performed in the study eye after pupil dilation. A negative change from Baseline indicates improvement and a positive change from baseline indicates worsening.
Outcome measures
| Measure |
Abicipar Pegol 2 mg
n=10 Participants
Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
|
Abicipar Pegol 1 mg
n=10 Participants
Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
|
Ranibizumab 0.5 mg
n=5 Participants
Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
|
|---|---|---|---|
|
Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye
Baseline
|
438.7 microns
Standard Deviation 107.32
|
475.1 microns
Standard Deviation 192.76
|
470.0 microns
Standard Deviation 67.75
|
|
Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye
Change from Baseline at Week 16
|
-196.5 microns
Standard Deviation 124.20
|
-187.3 microns
Standard Deviation 145.63
|
-230.4 microns
Standard Deviation 59.28
|
|
Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye
Change from Baseline at Week 20
|
-194.9 microns
Standard Deviation 109.37
|
-139.4 microns
Standard Deviation 110.66
|
-250.6 microns
Standard Deviation 50.69
|
Adverse Events
Abicipar Pegol 2 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Abicipar Pegol 1 mg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Ranibizumab 0.5 mg
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Abicipar Pegol 2 mg
n=10 participants at risk
Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
|
Abicipar Pegol 1 mg
n=10 participants at risk
Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
|
Ranibizumab 0.5 mg
n=5 participants at risk
Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
|
|---|---|---|---|
|
Eye disorders
Cataract
|
0.00%
0/10
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
0.00%
0/10
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
20.0%
1/5
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
|
Eye disorders
Angle closure glaucoma
|
0.00%
0/10
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
0.00%
0/10
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
20.0%
1/5
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.00%
0/10
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
0.00%
0/10
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
20.0%
1/5
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
|
Nervous system disorders
Embolic stroke
|
0.00%
0/10
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
0.00%
0/10
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
20.0%
1/5
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/10
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
0.00%
0/10
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
20.0%
1/5
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
Other adverse events
| Measure |
Abicipar Pegol 2 mg
n=10 participants at risk
Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
|
Abicipar Pegol 1 mg
n=10 participants at risk
Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
|
Ranibizumab 0.5 mg
n=5 participants at risk
Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
|
|---|---|---|---|
|
Eye disorders
Iritis
|
10.0%
1/10
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
10.0%
1/10
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
0.00%
0/5
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
|
Eye disorders
Vitreous floaters
|
10.0%
1/10
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
10.0%
1/10
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
0.00%
0/5
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
|
Eye disorders
Vitreous opacities
|
10.0%
1/10
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
10.0%
1/10
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
0.00%
0/5
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
|
Eye disorders
Foreign body sensation in eyes
|
10.0%
1/10
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
0.00%
0/10
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
20.0%
1/5
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/10
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
40.0%
4/10
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
0.00%
0/5
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
|
Eye disorders
Cataract
|
0.00%
0/10
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
10.0%
1/10
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
0.00%
0/5
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
|
Eye disorders
Anterior chamber inflammation
|
0.00%
0/10
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
10.0%
1/10
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
0.00%
0/5
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
|
Eye disorders
Asthenopia
|
0.00%
0/10
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
10.0%
1/10
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
0.00%
0/5
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
|
Infections and infestations
Cystitis
|
0.00%
0/10
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
10.0%
1/10
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
0.00%
0/5
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
|
General disorders
Device breakage
|
0.00%
0/10
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
10.0%
1/10
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
0.00%
0/5
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
|
Eye disorders
Dry eye
|
0.00%
0/10
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
10.0%
1/10
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
0.00%
0/5
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
|
Investigations
Eosinophil count increased
|
0.00%
0/10
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
10.0%
1/10
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
0.00%
0/5
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.00%
0/10
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
10.0%
1/10
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
0.00%
0/5
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/10
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
10.0%
1/10
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
0.00%
0/5
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/10
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
10.0%
1/10
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
0.00%
0/5
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/10
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
10.0%
1/10
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
0.00%
0/5
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
|
Infections and infestations
Periodontitis
|
0.00%
0/10
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
10.0%
1/10
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
0.00%
0/5
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
|
Eye disorders
Vision blurred
|
0.00%
0/10
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
10.0%
1/10
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
0.00%
0/5
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
|
Eye disorders
Vitritis
|
0.00%
0/10
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
10.0%
1/10
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
0.00%
0/5
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
|
Investigations
Intraocular pressure increased
|
0.00%
0/10
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
0.00%
0/10
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
40.0%
2/5
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/10
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
0.00%
0/10
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
20.0%
1/5
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
|
Investigations
Blood pressure increased
|
0.00%
0/10
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
0.00%
0/10
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
20.0%
1/5
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/10
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
0.00%
0/10
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
20.0%
1/5
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/10
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
0.00%
0/10
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
20.0%
1/5
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
|
Eye disorders
Retinal exudates
|
0.00%
0/10
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
0.00%
0/10
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
20.0%
1/5
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If the site intends to publish the Clinical Trial results and other information with an academic intention, or Allergan intends to utilize the related information for distribution activities of its own, the said party must obtain the consent from the other party in advance. However, except for the case based on the due reason including that the consent of trial subjects cannot be obtained though it is mandatory, the other party cannot refuse the consent.
- Publication restrictions are in place
Restriction type: OTHER