Trial Outcomes & Findings for Safety and Efficacy of Brimonidine Intravitreal Implant in Patients With Geographic Atrophy Due to Age-related Macular Degeneration (AMD) (NCT NCT00658619)
NCT ID: NCT00658619
Last Updated: 2018-08-21
Results Overview
Change from baseline in size of geographic atrophy lesion area in the study eye is based on fundus photography as read by an independent Reading Center. Photographs are taken with a specialized microscope with an attached camera to photograph the interior of the eye, including the retina and optic disc. A positive change from baseline indicates an increase in size of geographic atrophy lesion area (worsening; disease progression). Data are reported in disc area where 1 disc area = 1.767 millimeters squared (mm\^2).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
119 participants
Primary outcome timeframe
Baseline, Month 12
Results posted on
2018-08-21
Participant Flow
Stage 1 of the study was a patient-masked, dose-escalation, paired-eye comparison and the Investigator was not masked. Stage 2 was a parallel-group, sham-controlled, paired-eye comparison. Investigators were masked as to dose received for patients in the active treatment groups. No patients from Stage 1 were enrolled in Stage 2.
Participant milestones
| Measure |
400 µg Brimonidine Tartrate Implant Stage 1
Stage 1: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
|
200 µg Brimonidine Tartrate Implant Stage 1
Stage 1: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
|
400 µg Brimonidine Tartrate Implant Stage 2
Stage 2: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
|
200 µg Brimonidine Tartrate Implant Stage 2
Stage 2: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
|
Sham (no Implant) Stage 2
Stage 2: sham in both eyes on Day 1 and Month 6.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
41
|
49
|
23
|
|
Overall Study
COMPLETED
|
3
|
2
|
31
|
37
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
10
|
12
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of Brimonidine Intravitreal Implant in Patients With Geographic Atrophy Due to Age-related Macular Degeneration (AMD)
Baseline characteristics by cohort
| Measure |
400 µg Brimonidine Tartrate Implant Stage 1
n=3 Participants
Stage 1: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
|
200 µg Brimonidine Tartrate Implant Stage 1
n=3 Participants
Stage 1: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
|
400 µg Brimonidine Tartrate Implant Stage 2
n=41 Participants
Stage 2: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
|
200 µg Brimonidine Tartrate Implant Stage 2
n=49 Participants
Stage 2: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
|
Sham (no Implant) Stage 2
n=23 Participants
Stage 2: sham in both eyes on Day 1 and Month 6.
|
Total
n=119 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
85.0 Years
STANDARD_DEVIATION 3.61 • n=5 Participants
|
79.0 Years
STANDARD_DEVIATION 3.00 • n=7 Participants
|
75.6 Years
STANDARD_DEVIATION 8.78 • n=5 Participants
|
77.0 Years
STANDARD_DEVIATION 9.13 • n=4 Participants
|
78.4 Years
STANDARD_DEVIATION 5.80 • n=21 Participants
|
77.0 Years
STANDARD_DEVIATION 8.33 • n=10 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
72 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
47 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 12Population: Intent-to-Treat: All randomized patients who participated in Stage 2
Change from baseline in size of geographic atrophy lesion area in the study eye is based on fundus photography as read by an independent Reading Center. Photographs are taken with a specialized microscope with an attached camera to photograph the interior of the eye, including the retina and optic disc. A positive change from baseline indicates an increase in size of geographic atrophy lesion area (worsening; disease progression). Data are reported in disc area where 1 disc area = 1.767 millimeters squared (mm\^2).
Outcome measures
| Measure |
400 µg Brimonidine Tartrate Implant Stage 2
n=41 Participants
Stage 2: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
|
200 µg Brimonidine Tartrate Implant Stage 2
n=49 Participants
Stage 2: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
|
Sham (no Implant) Stage 2
n=23 Participants
Stage 2: sham in both eyes on Day 1 and Month 6.
|
|---|---|---|---|
|
Change From Baseline in Size of Geographic Atrophy Lesion Area in the Study Eye
Baseline
|
6.219 Disc Area
Standard Deviation 3.9524
|
6.897 Disc Area
Standard Deviation 4.6397
|
5.526 Disc Area
Standard Deviation 4.7890
|
|
Change From Baseline in Size of Geographic Atrophy Lesion Area in the Study Eye
Change from Baseline at Month 12
|
0.898 Disc Area
Standard Deviation 0.7520
|
1.006 Disc Area
Standard Deviation 0.7858
|
1.239 Disc Area
Standard Deviation 1.1645
|
SECONDARY outcome
Timeframe: Baseline, Month 3, Month 6, Month 9, Month 18, Month 24Population: Intent-to-Treat: All randomized patients who participated in Stage 2
Change from baseline in size of geographic atrophy lesion area in the study eye is based on fundus photography as read by an independent Reading Center. Photographs are taken with a specialized microscope with an attached camera to photograph the interior of the eye, including the retina and optic disc. A positive change from baseline indicates an increase in size of geographic atrophy lesion area (worsening; disease progression). Data are reported in disc area where 1 disc area = 1.767 millimeters squared (mm\^2).
Outcome measures
| Measure |
400 µg Brimonidine Tartrate Implant Stage 2
n=41 Participants
Stage 2: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
|
200 µg Brimonidine Tartrate Implant Stage 2
n=49 Participants
Stage 2: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
|
Sham (no Implant) Stage 2
n=23 Participants
Stage 2: sham in both eyes on Day 1 and Month 6.
|
|---|---|---|---|
|
Change From Baseline in Size of Geographic Atrophy Lesion Area in the Study Eye
Baseline
|
6.219 Disc Area
Standard Deviation 3.9524
|
6.897 Disc Area
Standard Deviation 4.6397
|
5.526 Disc Area
Standard Deviation 4.7890
|
|
Change From Baseline in Size of Geographic Atrophy Lesion Area in the Study Eye
Change from Baseline at Month 3
|
0.182 Disc Area
Standard Deviation 0.3353
|
0.117 Disc Area
Standard Deviation 0.6612
|
0.399 Disc Area
Standard Deviation 0.3713
|
|
Change From Baseline in Size of Geographic Atrophy Lesion Area in the Study Eye
Change from Baseline at Month 6
|
0.482 Disc Area
Standard Deviation 0.6325
|
0.570 Disc Area
Standard Deviation 0.5749
|
0.609 Disc Area
Standard Deviation 0.5474
|
|
Change From Baseline in Size of Geographic Atrophy Lesion Area in the Study Eye
Change from Baseline at Month 9
|
0.641 Disc Area
Standard Deviation 0.6847
|
0.798 Disc Area
Standard Deviation 0.6424
|
0.857 Disc Area
Standard Deviation 0.7267
|
|
Change From Baseline in Size of Geographic Atrophy Lesion Area in the Study Eye
Change from Baseline at Month 18
|
1.306 Disc Area
Standard Deviation 1.0164
|
1.413 Disc Area
Standard Deviation 1.0291
|
1.697 Disc Area
Standard Deviation 1.4185
|
|
Change From Baseline in Size of Geographic Atrophy Lesion Area in the Study Eye
Change from Baseline at Month 24
|
1.744 Disc Area
Standard Deviation 1.4010
|
1.991 Disc Area
Standard Deviation 1.4469
|
2.178 Disc Area
Standard Deviation 1.7042
|
SECONDARY outcome
Timeframe: Baseline, 24 MonthsPopulation: Intent-to-Treat: All randomized patients who participated in Stage 2
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). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening.
Outcome measures
| Measure |
400 µg Brimonidine Tartrate Implant Stage 2
n=41 Participants
Stage 2: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
|
200 µg Brimonidine Tartrate Implant Stage 2
n=49 Participants
Stage 2: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
|
Sham (no Implant) Stage 2
n=23 Participants
Stage 2: sham in both eyes on Day 1 and Month 6.
|
|---|---|---|---|
|
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
Baseline
|
54.8 Number of Letters Read Correctly
Standard Deviation 12.89
|
52.1 Number of Letters Read Correctly
Standard Deviation 13.91
|
53.7 Number of Letters Read Correctly
Standard Deviation 10.71
|
|
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
Change from Baseline at 24 Months
|
-5.0 Number of Letters Read Correctly
Standard Deviation 13.77
|
-3.2 Number of Letters Read Correctly
Standard Deviation 12.87
|
-3.3 Number of Letters Read Correctly
Standard Deviation 12.98
|
SECONDARY outcome
Timeframe: Baseline, 24 MonthsPopulation: Intent-to-Treat: All randomized patients who participated in Stage 2
Change from baseline in contrast sensitivity in the study eye is measured using a Pelli-Robson contrast sensitivity chart at 1 meter. The contrast sensitivity chart contains letters that are darkest at the top and then get progressively lighter. Scores range from 0 to 48 and are based on the number of letters read correctly. A negative change from baseline indicates a worsening in contrast sensitivity and a positive change from baseline indicates an improvement.
Outcome measures
| Measure |
400 µg Brimonidine Tartrate Implant Stage 2
n=41 Participants
Stage 2: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
|
200 µg Brimonidine Tartrate Implant Stage 2
n=49 Participants
Stage 2: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
|
Sham (no Implant) Stage 2
n=23 Participants
Stage 2: sham in both eyes on Day 1 and Month 6.
|
|---|---|---|---|
|
Change From Baseline in Contrast Sensitivity in the Study Eye
Baseline
|
23.7 Number of Letters Read Correctly
Standard Deviation 5.60
|
22.1 Number of Letters Read Correctly
Standard Deviation 5.76
|
21.7 Number of Letters Read Correctly
Standard Deviation 7.56
|
|
Change From Baseline in Contrast Sensitivity in the Study Eye
Change from Baseline at 24 Months
|
-0.9 Number of Letters Read Correctly
Standard Deviation 4.33
|
1.1 Number of Letters Read Correctly
Standard Deviation 7.22
|
0.6 Number of Letters Read Correctly
Standard Deviation 7.49
|
SECONDARY outcome
Timeframe: Baseline, 24 MonthsPopulation: Intent-to-Treat: All randomized patients who participated in Stage 2
Change from baseline in reading speed in the study eye is assessed using modified Bailey-Lovie word charts. Patients read the chart for 2 minutes and the numbers of words read correctly per minute are totaled. An increase in the number of words read correctly indicates an improvement and a decrease in the number of words read correctly indicates a worsening.
Outcome measures
| Measure |
400 µg Brimonidine Tartrate Implant Stage 2
n=41 Participants
Stage 2: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
|
200 µg Brimonidine Tartrate Implant Stage 2
n=49 Participants
Stage 2: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
|
Sham (no Implant) Stage 2
n=23 Participants
Stage 2: sham in both eyes on Day 1 and Month 6.
|
|---|---|---|---|
|
Change From Baseline in Reading Speed in the Study Eye
Baseline
|
10.21 Words per Minute (wpm)
Standard Deviation 8.532
|
9.62 Words per Minute (wpm)
Standard Deviation 9.224
|
8.72 Words per Minute (wpm)
Standard Deviation 6.832
|
|
Change From Baseline in Reading Speed in the Study Eye
Change from Baseline at 24 Months
|
-1.15 Words per Minute (wpm)
Standard Deviation 5.527
|
-0.28 Words per Minute (wpm)
Standard Deviation 7.035
|
0.45 Words per Minute (wpm)
Standard Deviation 4.705
|
Adverse Events
400 µg Brimonidine Tartrate Implant
Serious events: 14 serious events
Other events: 38 other events
Deaths: 0 deaths
200 µg Brimonidine Tartrate Implant
Serious events: 20 serious events
Other events: 47 other events
Deaths: 0 deaths
Sham (no Implant) Stage 2
Serious events: 9 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
400 µg Brimonidine Tartrate Implant
n=43 participants at risk
Stage 1 and 2 combined: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
|
200 µg Brimonidine Tartrate Implant
n=51 participants at risk
Stage 1 and 2 combined: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
|
Sham (no Implant) Stage 2
n=23 participants at risk
Stage 2: sham in both eyes on Day 1 and Month 6.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
2.0%
1/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
4.3%
1/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Cardiac disorders
Angina Unstable
|
2.3%
1/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
2.3%
1/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
2.0%
1/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Cardiac disorders
Coronary Artery Disease
|
2.3%
1/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
2.0%
1/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Cardiac disorders
Acute Myocardial Infarction
|
2.3%
1/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
2.0%
1/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
4.3%
1/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Cardiac disorders
Atrial Fibrillation
|
2.3%
1/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
2.0%
1/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
4.3%
1/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Cardiac disorders
Myocardial Infarction
|
2.3%
1/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
3.9%
2/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
2.0%
1/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Cardiac disorders
Aortic Valve Stenosis
|
0.00%
0/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
2.0%
1/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Cardiac disorders
Atrial Flutter
|
0.00%
0/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
2.0%
1/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Cardiac disorders
Mitral Valve Stenosis
|
0.00%
0/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
2.0%
1/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Cardiac disorders
Sick Sinus Syndrome
|
0.00%
0/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
2.0%
1/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Ear and labyrinth disorders
Vertigo
|
2.3%
1/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Eye disorders
Visual Acuity Reduced
|
2.3%
1/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
2.3%
1/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Gastrointestinal disorders
Diverticulum
|
2.3%
1/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
2.3%
1/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.00%
0/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
4.3%
1/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Gastrointestinal disorders
Oesophageal Stenosis
|
0.00%
0/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
2.0%
1/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Infections and infestations
Diarrhoea Infectious
|
2.3%
1/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Infections and infestations
Urosepsis
|
2.3%
1/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Infections and infestations
Pneumonia
|
2.3%
1/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
2.0%
1/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
4.3%
1/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Infections and infestations
Clostridium Difficile Colitis
|
0.00%
0/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
4.3%
1/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
4.3%
1/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Infections and infestations
Urinary Tract Infection Bacterial
|
0.00%
0/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
4.3%
1/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
2.0%
1/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
2.3%
1/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
2.0%
1/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
4.3%
1/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
0.00%
0/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
8.7%
2/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
0.00%
0/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
2.0%
1/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.00%
0/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
2.0%
1/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.00%
0/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
3.9%
2/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.3%
1/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
2.0%
1/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
2.3%
1/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's Disease
|
2.3%
1/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Squamous Cell Carcinoma Stage Unspecified
|
2.3%
1/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma
|
2.3%
1/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
2.3%
1/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
2.0%
1/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
4.3%
1/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Cancer
|
0.00%
0/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
4.3%
1/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal Cancer
|
0.00%
0/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
4.3%
1/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Melanoma
|
0.00%
0/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
4.3%
1/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Cancer Metastatic
|
0.00%
0/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
2.0%
1/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's Lymphoma
|
0.00%
0/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
2.0%
1/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small Cell Lung Cancer Stage Unspecified
|
0.00%
0/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
2.0%
1/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional Cell Carcinoma
|
0.00%
0/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
2.0%
1/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Nervous system disorders
Syncope
|
2.3%
1/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
4.3%
1/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Nervous system disorders
Cerebrovascular Accident
|
2.3%
1/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
3.9%
2/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Nervous system disorders
Carotid Artery Stenosis
|
0.00%
0/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
4.3%
1/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
4.3%
1/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Nervous system disorders
Intracranial Aneurysm
|
0.00%
0/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
2.0%
1/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.00%
0/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
2.0%
1/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Renal and urinary disorders
Renal Failure Acute
|
2.3%
1/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Renal and urinary disorders
Stress Urinary Incontinence
|
2.3%
1/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Vascular Disorder
|
2.3%
1/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
4.3%
1/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
4.3%
1/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
4.3%
1/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
2.0%
1/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
4.3%
1/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
2.0%
1/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Vascular disorders
Hypotension
|
0.00%
0/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
4.3%
1/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Vascular disorders
Aortic Stenosis
|
0.00%
0/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
2.0%
1/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
Other adverse events
| Measure |
400 µg Brimonidine Tartrate Implant
n=43 participants at risk
Stage 1 and 2 combined: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
|
200 µg Brimonidine Tartrate Implant
n=51 participants at risk
Stage 1 and 2 combined: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
|
Sham (no Implant) Stage 2
n=23 participants at risk
Stage 2: sham in both eyes on Day 1 and Month 6.
|
|---|---|---|---|
|
Infections and infestations
Pneumonia
|
2.3%
1/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
5.9%
3/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
4.3%
1/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Blood and lymphatic system disorders
Anaemia
|
2.3%
1/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
9.8%
5/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
13.0%
3/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Injury, poisoning and procedural complications
Fall
|
2.3%
1/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
5.9%
3/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
4.3%
1/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
0.00%
0/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
8.7%
2/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
2.3%
1/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
13.0%
3/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
5.9%
3/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Cardiac disorders
Coronary Artery Disease
|
2.3%
1/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
3.9%
2/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
8.7%
2/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
5.9%
3/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
4.3%
1/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
2.0%
1/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
8.7%
2/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Eye disorders
Conjunctival Haemorrhage
|
27.9%
12/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
41.2%
21/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
8.7%
2/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Eye disorders
Punctate Keratitis
|
11.6%
5/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
2.0%
1/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Eye disorders
Eye Pain
|
11.6%
5/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
2.0%
1/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
4.3%
1/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Eye disorders
Vitreous Floaters
|
7.0%
3/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
3.9%
2/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Eye disorders
Cataract
|
9.3%
4/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
5.9%
3/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
4.3%
1/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Eye disorders
Retinal Haemorrhage
|
7.0%
3/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
5.9%
3/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
8.7%
2/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Eye disorders
Posterior Capsule Opacification
|
7.0%
3/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Eye disorders
Visual Acuity Reduced
|
7.0%
3/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
5.9%
3/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Eye disorders
Conjunctival Hyperaemia
|
7.0%
3/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
13.7%
7/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
13.0%
3/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Eye disorders
Vitreous Haemorrhage
|
4.7%
2/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
5.9%
3/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Eye disorders
Vitreous Detachment
|
4.7%
2/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
2.0%
1/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
8.7%
2/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Gastrointestinal disorders
Dental Caries
|
0.00%
0/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
8.7%
2/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
5.9%
3/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
8.7%
2/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
5.9%
3/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
13.0%
3/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Infections and infestations
Sinusitis
|
9.3%
4/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
4.3%
1/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Infections and infestations
Urinary Tract Infection
|
7.0%
3/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
9.8%
5/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
8.7%
2/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Infections and infestations
Ear Infection
|
2.3%
1/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
3.9%
2/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
8.7%
2/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Nervous system disorders
Syncope
|
7.0%
3/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
2.0%
1/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
8.7%
2/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Nervous system disorders
Cerebrovascular Accident
|
2.3%
1/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
5.9%
3/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
8.7%
2/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep Apnoea Syndrome
|
0.00%
0/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
8.7%
2/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
0.00%
0/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
8.7%
2/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Vascular disorders
Hypertension
|
4.7%
2/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
2.0%
1/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
17.4%
4/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/43
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
5.9%
3/51
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
4.3%
1/23
The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all patients who were enrolled and treated in the study. For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events are reported, regardless of eye.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER