Trial Outcomes & Findings for Safety and Efficacy of a New Ophthalmic Formulation of Bimatoprost in Patients With Open Angle Glaucoma and Ocular Hypertension (NCT NCT01157364)
NCT ID: NCT01157364
Last Updated: 2020-03-30
Results Overview
IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
109 participants
Primary outcome timeframe
Baseline, Month 24
Results posted on
2020-03-30
Participant Flow
Participant milestones
| Measure |
Bimatoprost 20 µg Generation 2, Bimatoprost 0.03%
Single dose of bimatoprost ophthalmic 20 µg generation 2 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
|
Bimatoprost 15 µg Generation 2, Bimatoprost 0.03%
Single dose of bimatoprost ophthalmic 15 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
|
Bimatoprost 10 µg Generation 2, Bimatoprost 0.03%
Single dose of bimatoprost ophthalmic 10 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
|
Bimatoprost 6 µg Generation 2, Bimatoprost 0.03%
Single dose of bimatoprost ophthalmic 6 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
|
Bimatoprost 15 µg Generation 1, Bimatoprost 0.03%
Single dose of bimatoprost ophthalmic 15 µg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
|
Bimatoprost 10 µg Generation 1, Bimatoprost 0.03%
Single dose of bimatoprost ophthalmic 10 µg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
21
|
21
|
18
|
11
|
23
|
|
Overall Study
COMPLETED
|
13
|
17
|
17
|
16
|
9
|
22
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
4
|
2
|
2
|
1
|
Reasons for withdrawal
| Measure |
Bimatoprost 20 µg Generation 2, Bimatoprost 0.03%
Single dose of bimatoprost ophthalmic 20 µg generation 2 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
|
Bimatoprost 15 µg Generation 2, Bimatoprost 0.03%
Single dose of bimatoprost ophthalmic 15 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
|
Bimatoprost 10 µg Generation 2, Bimatoprost 0.03%
Single dose of bimatoprost ophthalmic 10 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
|
Bimatoprost 6 µg Generation 2, Bimatoprost 0.03%
Single dose of bimatoprost ophthalmic 6 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
|
Bimatoprost 15 µg Generation 1, Bimatoprost 0.03%
Single dose of bimatoprost ophthalmic 15 µg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
|
Bimatoprost 10 µg Generation 1, Bimatoprost 0.03%
Single dose of bimatoprost ophthalmic 10 µg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
|
|---|---|---|---|---|---|---|
|
Overall Study
Other Reasons
|
1
|
1
|
2
|
1
|
0
|
0
|
|
Overall Study
Personal Reasons
|
0
|
2
|
0
|
0
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
1
|
0
|
1
|
0
|
Baseline Characteristics
Safety and Efficacy of a New Ophthalmic Formulation of Bimatoprost in Patients With Open Angle Glaucoma and Ocular Hypertension
Baseline characteristics by cohort
| Measure |
Bimatoprost 20 µg Generation 2, Bimatoprost 0.03%
n=15 Participants
Single dose of bimatoprost ophthalmic 20 µg generation 2 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
|
Bimatoprost 15 µg Generation 2, Bimatoprost 0.03%
n=21 Participants
Single dose of bimatoprost ophthalmic 15 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
|
Bimatoprost 10 µg Generation 2, Bimatoprost 0.03%
n=21 Participants
Single dose of bimatoprost ophthalmic 10 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
|
Bimatoprost 6 µg Generation 2, Bimatoprost 0.03%
n=18 Participants
Single dose of bimatoprost ophthalmic 6 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
|
Bimatoprost 15 µg Generation 1, Bimatoprost 0.03%
n=11 Participants
Single dose of bimatoprost ophthalmic 15 µg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
|
Bimatoprost 10 µg Generation 1, Bimatoprost 0.03%
n=23 Participants
Single dose of bimatoprost ophthalmic 10 µg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
|
Total
n=109 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Customized
<45 years
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
|
Age, Customized
45-65 years
|
6 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
10 Participants
n=10 Participants
|
49 Participants
n=115 Participants
|
|
Age, Customized
>65 years
|
8 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
8 Participants
n=36 Participants
|
12 Participants
n=10 Participants
|
54 Participants
n=115 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
12 Participants
n=483 Participants
|
5 Participants
n=36 Participants
|
13 Participants
n=10 Participants
|
56 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
10 Participants
n=10 Participants
|
53 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 24Population: Modified Intent-to-Treat: all treated patients with at least 1 IOP measurement at baseline and at least 1 postbaseline IOP measurement through Week 16. Excluding IOP assessments after rescue or retreatment.
IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
Outcome measures
| Measure |
Bimatoprost 20 µg Generation 2, Bimatoprost 0.03%
n=15 Participants
Single dose of bimatoprost ophthalmic 20 µg generation 2 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
|
Bimatoprost 15 µg Generation 2, Bimatoprost 0.03%
n=21 Participants
Single dose of bimatoprost ophthalmic 15 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
|
Bimatoprost 10 µg Generation 2, Bimatoprost 0.03%
n=21 Participants
Single dose of bimatoprost ophthalmic 10 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
|
Bimatoprost 6 µg Generation 2, Bimatoprost 0.03%
n=18 Participants
Single dose of bimatoprost ophthalmic 6 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
|
Bimatoprost 15 μg Generation 1, Bimatoprost 0.03%
n=11 Participants
Single dose of bimatoprost ophthalmic 15 μg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
|
Bimatoprost 10 μg Generation 1, Bimatoprost 0.03%
n=23 Participants
Single dose of bimatoprost ophthalmic 10 μg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye
Baseline Hour 0,
|
26.57 Millimeters of Mercury (mmHg)
Standard Deviation 4.144
|
25.14 Millimeters of Mercury (mmHg)
Standard Deviation 2.967
|
24.48 Millimeters of Mercury (mmHg)
Standard Deviation 2.112
|
25.14 Millimeters of Mercury (mmHg)
Standard Deviation 3.609
|
23.73 Millimeters of Mercury (mmHg)
Standard Deviation 1.664
|
24.22 Millimeters of Mercury (mmHg)
Standard Deviation 2.104
|
|
Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye
Week 4, Hour 0
|
-8.83 Millimeters of Mercury (mmHg)
Standard Deviation 3.750
|
-7.80 Millimeters of Mercury (mmHg)
Standard Deviation 2.613
|
-7.18 Millimeters of Mercury (mmHg)
Standard Deviation 3.250
|
-7.09 Millimeters of Mercury (mmHg)
Standard Deviation 2.697
|
-5.50 Millimeters of Mercury (mmHg)
Standard Deviation 3.507
|
-7.33 Millimeters of Mercury (mmHg)
Standard Deviation 3.006
|
|
Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye
Week 12, Hour 0
|
-7.92 Millimeters of Mercury (mmHg)
Standard Deviation 2.557
|
-7.02 Millimeters of Mercury (mmHg)
Standard Deviation 3.215
|
-6.82 Millimeters of Mercury (mmHg)
Standard Deviation 3.024
|
-6.53 Millimeters of Mercury (mmHg)
Standard Deviation 4.091
|
-5.95 Millimeters of Mercury (mmHg)
Standard Deviation 3.546
|
-7.00 Millimeters of Mercury (mmHg)
Standard Deviation 2.899
|
|
Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye
Month 6, Hour 0
|
-5.65 Millimeters of Mercury (mmHg)
Standard Deviation 3.652
|
-6.50 Millimeters of Mercury (mmHg)
Standard Deviation 2.646
|
-5.38 Millimeters of Mercury (mmHg)
Standard Deviation 3.015
|
-6.81 Millimeters of Mercury (mmHg)
Standard Deviation 2.529
|
-3.94 Millimeters of Mercury (mmHg)
Standard Deviation 4.170
|
-5.40 Millimeters of Mercury (mmHg)
Standard Deviation 3.106
|
|
Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye
Month 12, Hour 0
|
-9.00 Millimeters of Mercury (mmHg)
Standard Deviation 2.387
|
-5.64 Millimeters of Mercury (mmHg)
Standard Deviation 2.824
|
-6.00 Millimeters of Mercury (mmHg)
Standard Deviation 2.881
|
-5.38 Millimeters of Mercury (mmHg)
Standard Deviation 3.091
|
-5.80 Millimeters of Mercury (mmHg)
Standard Deviation 4.251
|
-5.71 Millimeters of Mercury (mmHg)
Standard Deviation 2.138
|
|
Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye
Month 18, Hour 0
|
-6.00 Millimeters of Mercury (mmHg)
Standard Deviation 3.464
|
-6.92 Millimeters of Mercury (mmHg)
Standard Deviation 2.558
|
-7.70 Millimeters of Mercury (mmHg)
Standard Deviation 3.493
|
-6.93 Millimeters of Mercury (mmHg)
Standard Deviation 2.335
|
-4.25 Millimeters of Mercury (mmHg)
Standard Deviation 0.354
|
-9.75 Millimeters of Mercury (mmHg)
Standard Deviation 3.182
|
|
Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye
Month 24, Hour 0
|
-5.75 Millimeters of Mercury (mmHg)
Standard Deviation 4.330
|
-7.30 Millimeters of Mercury (mmHg)
Standard Deviation 2.019
|
-7.40 Millimeters of Mercury (mmHg)
Standard Deviation 1.557
|
-5.70 Millimeters of Mercury (mmHg)
Standard Deviation 2.197
|
-8.50 Millimeters of Mercury (mmHg)
Standard Deviation NA
Standard Deviation is not applicable since there is only 1 patient.
|
-5.50 Millimeters of Mercury (mmHg)
Standard Deviation NA
Standard Deviation is not applicable since there is only 1 patient.
|
SECONDARY outcome
Timeframe: Baseline to Month 6Population: Modified Intent-to-Treat: all treated patients with at least 1 IOP measurement at baseline and at least 1 postbaseline IOP measurement through Week 16. Excluding IOP assessments after rescue or retreatment.
IOP is a measurement of the fluid pressure inside the study eye.
Outcome measures
| Measure |
Bimatoprost 20 µg Generation 2, Bimatoprost 0.03%
n=15 Participants
Single dose of bimatoprost ophthalmic 20 µg generation 2 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
|
Bimatoprost 15 µg Generation 2, Bimatoprost 0.03%
n=21 Participants
Single dose of bimatoprost ophthalmic 15 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
|
Bimatoprost 10 µg Generation 2, Bimatoprost 0.03%
n=21 Participants
Single dose of bimatoprost ophthalmic 10 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
|
Bimatoprost 6 µg Generation 2, Bimatoprost 0.03%
n=18 Participants
Single dose of bimatoprost ophthalmic 6 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
|
Bimatoprost 15 μg Generation 1, Bimatoprost 0.03%
n=11 Participants
Single dose of bimatoprost ophthalmic 15 μg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
|
Bimatoprost 10 μg Generation 1, Bimatoprost 0.03%
n=23 Participants
Single dose of bimatoprost ophthalmic 10 μg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
|
|---|---|---|---|---|---|---|
|
Time-Matched Intraocular Pressure (IOP) in the Study Eye
Week 12, Hour 0
|
17.71 Millimeters of Mercury (mmHg)
Standard Deviation 2.996
|
18.12 Millimeters of Mercury (mmHg)
Standard Deviation 3.626
|
17.61 Millimeters of Mercury (mmHg)
Standard Deviation 2.289
|
18.03 Millimeters of Mercury (mmHg)
Standard Deviation 3.659
|
17.77 Millimeters of Mercury (mmHg)
Standard Deviation 2.970
|
17.23 Millimeters of Mercury (mmHg)
Standard Deviation 2.443
|
|
Time-Matched Intraocular Pressure (IOP) in the Study Eye
Baseline, Hour 0
|
26.57 Millimeters of Mercury (mmHg)
Standard Deviation 4.144
|
25.14 Millimeters of Mercury (mmHg)
Standard Deviation 2.967
|
24.48 Millimeters of Mercury (mmHg)
Standard Deviation 2.112
|
25.14 Millimeters of Mercury (mmHg)
Standard Deviation 3.609
|
23.73 Millimeters of Mercury (mmHg)
Standard Deviation 1.664
|
24.22 Millimeters of Mercury (mmHg)
Standard Deviation 2.104
|
|
Time-Matched Intraocular Pressure (IOP) in the Study Eye
Week 4, Hour 0
|
17.73 Millimeters of Mercury (mmHg)
Standard Deviation 3.982
|
17.45 Millimeters of Mercury (mmHg)
Standard Deviation 2.032
|
17.55 Millimeters of Mercury (mmHg)
Standard Deviation 3.166
|
17.53 Millimeters of Mercury (mmHg)
Standard Deviation 2.661
|
18.23 Millimeters of Mercury (mmHg)
Standard Deviation 4.315
|
17.00 Millimeters of Mercury (mmHg)
Standard Deviation 2.748
|
|
Time-Matched Intraocular Pressure (IOP) in the Study Eye
Month 6, Hour 0
|
19.10 Millimeters of Mercury (mmHg)
Standard Deviation 3.843
|
17.90 Millimeters of Mercury (mmHg)
Standard Deviation 3.785
|
19.35 Millimeters of Mercury (mmHg)
Standard Deviation 2.536
|
17.35 Millimeters of Mercury (mmHg)
Standard Deviation 2.135
|
19.44 Millimeters of Mercury (mmHg)
Standard Deviation 3.610
|
18.80 Millimeters of Mercury (mmHg)
Standard Deviation 3.282
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: Modified Intent-to-Treat: all treated patients with at least 1 IOP measurement at baseline and at least 1 postbaseline IOP measurement through Week 16. Including IOP assessments after rescue or retreatment.
IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0, 2, 4, 6, and 8 and averaged to determine the mean diurnal IOP.
Outcome measures
| Measure |
Bimatoprost 20 µg Generation 2, Bimatoprost 0.03%
n=15 Participants
Single dose of bimatoprost ophthalmic 20 µg generation 2 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
|
Bimatoprost 15 µg Generation 2, Bimatoprost 0.03%
n=21 Participants
Single dose of bimatoprost ophthalmic 15 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
|
Bimatoprost 10 µg Generation 2, Bimatoprost 0.03%
n=21 Participants
Single dose of bimatoprost ophthalmic 10 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
|
Bimatoprost 6 µg Generation 2, Bimatoprost 0.03%
n=18 Participants
Single dose of bimatoprost ophthalmic 6 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
|
Bimatoprost 15 μg Generation 1, Bimatoprost 0.03%
n=11 Participants
Single dose of bimatoprost ophthalmic 15 μg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
|
Bimatoprost 10 μg Generation 1, Bimatoprost 0.03%
n=23 Participants
Single dose of bimatoprost ophthalmic 10 μg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
|
|---|---|---|---|---|---|---|
|
Mean Diurnal IOP in the Study Eye
Baseline
|
23.38 mmHg
Standard Deviation 3.967
|
23.74 mmHg
Standard Deviation 3.411
|
23.02 mmHg
Standard Deviation 2.011
|
23.54 mmHg
Standard Deviation 5.121
|
20.84 mmHg
Standard Deviation 2.123
|
22.09 mmHg
Standard Deviation 2.521
|
|
Mean Diurnal IOP in the Study Eye
Week 4
|
17.10 mmHg
Standard Deviation 4.584
|
16.59 mmHg
Standard Deviation 1.884
|
16.40 mmHg
Standard Deviation 2.529
|
17.35 mmHg
Standard Deviation 5.810
|
17.89 mmHg
Standard Deviation 2.038
|
16.88 mmHg
Standard Deviation 3.782
|
|
Mean Diurnal IOP in the Study Eye
Week 12
|
17.34 mmHg
Standard Deviation 3.608
|
18.22 mmHg
Standard Deviation 3.294
|
17.33 mmHg
Standard Deviation 2.274
|
17.29 mmHg
Standard Deviation 3.199
|
17.12 mmHg
Standard Deviation 2.211
|
17.06 mmHg
Standard Deviation 2.604
|
|
Mean Diurnal IOP in the Study Eye
Month 6
|
19.79 mmHg
Standard Deviation 4.498
|
18.51 mmHg
Standard Deviation 3.539
|
18.94 mmHg
Standard Deviation 2.879
|
16.71 mmHg
Standard Deviation 1.879
|
18.13 mmHg
Standard Deviation 3.080
|
18.55 mmHg
Standard Deviation 3.632
|
SECONDARY outcome
Timeframe: 24 MonthsPopulation: Modified Intent-to-Treat: all treated patients with at least 1 IOP measurement at baseline and at least 1 postbaseline IOP measurement through Week 16
Time to rescue treatment or the second treatment in the generation 2 groups is defined as the time between the first treatment and the second treatment in the study eye.
Outcome measures
| Measure |
Bimatoprost 20 µg Generation 2, Bimatoprost 0.03%
n=15 Participants
Single dose of bimatoprost ophthalmic 20 µg generation 2 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
|
Bimatoprost 15 µg Generation 2, Bimatoprost 0.03%
n=21 Participants
Single dose of bimatoprost ophthalmic 15 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
|
Bimatoprost 10 µg Generation 2, Bimatoprost 0.03%
n=21 Participants
Single dose of bimatoprost ophthalmic 10 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
|
Bimatoprost 6 µg Generation 2, Bimatoprost 0.03%
n=18 Participants
Single dose of bimatoprost ophthalmic 6 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
|
Bimatoprost 15 μg Generation 1, Bimatoprost 0.03%
n=11 Participants
Single dose of bimatoprost ophthalmic 15 μg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
|
Bimatoprost 10 μg Generation 1, Bimatoprost 0.03%
n=23 Participants
Single dose of bimatoprost ophthalmic 10 μg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
|
|---|---|---|---|---|---|---|
|
Time to Rescue Treatment or Re-Treatment in the Study Eye
|
328 Days
Interval 44.0 to 400.0
|
265 Days
Interval 119.0 to 534.0
|
273 Days
Interval 98.0 to 351.0
|
391.5 Days
Interval 13.0 to 553.0
|
411 Days
Interval 139.0 to 555.0
|
237 Days
Interval 2.0 to 611.0
|
Adverse Events
Bimatoprost 20 µg Generation 2, Bimatoprost 0.03%
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Bimatoprost 15 µg Generation 2, Bimatoprost 0.03%
Serious events: 3 serious events
Other events: 16 other events
Deaths: 0 deaths
Bimatoprost 10 µg Generation 2, Bimatoprost 0.03%
Serious events: 6 serious events
Other events: 17 other events
Deaths: 0 deaths
Bimatoprost 6 µg Generation 2, Bimatoprost 0.03%
Serious events: 4 serious events
Other events: 15 other events
Deaths: 0 deaths
Bimatoprost 15 µg Generation 1, Bimatoprost 0.03%
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
Bimatoprost 10 µg Generation 1, Bimatoprost 0.03%
Serious events: 3 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bimatoprost 20 µg Generation 2, Bimatoprost 0.03%
n=15 participants at risk
Single dose of bimatoprost ophthalmic 20 µg generation 2 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
|
Bimatoprost 15 µg Generation 2, Bimatoprost 0.03%
n=21 participants at risk
Single dose of bimatoprost ophthalmic 15 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
|
Bimatoprost 10 µg Generation 2, Bimatoprost 0.03%
n=21 participants at risk
Single dose of bimatoprost ophthalmic 10 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
|
Bimatoprost 6 µg Generation 2, Bimatoprost 0.03%
n=18 participants at risk
Single dose of bimatoprost ophthalmic 6 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
|
Bimatoprost 15 µg Generation 1, Bimatoprost 0.03%
n=11 participants at risk
Single dose of bimatoprost ophthalmic 15 µg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
|
Bimatoprost 10 µg Generation 1, Bimatoprost 0.03%
n=23 participants at risk
Single dose of bimatoprost ophthalmic 10 µg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Neutropenic Sepsis
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
9.1%
1/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mantle Cell Lymphoma Stage IV
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
9.1%
1/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Cardiac disorders
Coronary Artery Disease
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.3%
1/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Gastrointestinal disorders
Hematemesis
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.3%
1/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Nervous system disorders
Carotid Artery Stenosis
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.8%
1/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.3%
1/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.8%
1/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal Carcinoma
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.8%
1/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Ascites
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.8%
1/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.8%
1/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.8%
1/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.8%
1/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil Cancer
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.8%
1/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.8%
1/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.8%
1/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Gastrointestinal disorders
Large Intestine Polyp
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.8%
1/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.8%
1/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Eye disorders
Retinal Detachment
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
5.6%
1/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Injury, poisoning and procedural complications
Cervical Vertebral Fracture
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
5.6%
1/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Melanoma
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
5.6%
1/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
5.6%
1/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Renal and urinary disorders
Urinary Incontinence
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
5.6%
1/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
9.1%
1/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Cardiac disorders
Atrioventricular Block
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
9.1%
1/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Gastrointestinal disorders
Gastric Ulcer Haemorrhage
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
9.1%
1/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
General disorders
Non-cardiac Chest Pain
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
9.1%
1/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Immune system disorders
Allergy to Arthropod Sting
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
9.1%
1/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.3%
1/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
Other adverse events
| Measure |
Bimatoprost 20 µg Generation 2, Bimatoprost 0.03%
n=15 participants at risk
Single dose of bimatoprost ophthalmic 20 µg generation 2 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
|
Bimatoprost 15 µg Generation 2, Bimatoprost 0.03%
n=21 participants at risk
Single dose of bimatoprost ophthalmic 15 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
|
Bimatoprost 10 µg Generation 2, Bimatoprost 0.03%
n=21 participants at risk
Single dose of bimatoprost ophthalmic 10 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
|
Bimatoprost 6 µg Generation 2, Bimatoprost 0.03%
n=18 participants at risk
Single dose of bimatoprost ophthalmic 6 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
|
Bimatoprost 15 µg Generation 1, Bimatoprost 0.03%
n=11 participants at risk
Single dose of bimatoprost ophthalmic 15 µg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
|
Bimatoprost 10 µg Generation 1, Bimatoprost 0.03%
n=23 participants at risk
Single dose of bimatoprost ophthalmic 10 µg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
|
|---|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.8%
1/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal Carcinoma
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.8%
1/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Ascites
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.8%
1/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Eye disorders
Conjunctival Hyperaemia
|
46.7%
7/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
38.1%
8/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
33.3%
7/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
44.4%
8/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
9.1%
1/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
30.4%
7/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Eye disorders
Foreign Body Sensation in Eyes
|
26.7%
4/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
9.5%
2/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
14.3%
3/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
22.2%
4/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
18.2%
2/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
13.0%
3/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Eye disorders
Dry Eye
|
20.0%
3/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.8%
1/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.8%
1/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
9.1%
1/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
8.7%
2/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Eye disorders
Eye Pain
|
20.0%
3/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
19.0%
4/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
19.0%
4/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
5.6%
1/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
18.2%
2/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
13.0%
3/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Eye disorders
Punctate Keratitis
|
20.0%
3/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
9.5%
2/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
14.3%
3/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
11.1%
2/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
9.1%
1/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.3%
1/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Eye disorders
Conjunctival Haemorrhage
|
13.3%
2/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
19.0%
4/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
14.3%
3/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
16.7%
3/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
9.1%
1/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
21.7%
5/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Eye disorders
Growth of Eyelashes
|
13.3%
2/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.8%
1/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.8%
1/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
5.6%
1/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Eye disorders
Iris Hyperpigmentation
|
13.3%
2/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.8%
1/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Eye disorders
Photophobia
|
13.3%
2/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
14.3%
3/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
19.0%
4/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
18.2%
2/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
13.0%
3/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Eye disorders
Vision Blurred
|
13.3%
2/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
9.5%
2/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
9.5%
2/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
11.1%
2/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
9.1%
1/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
13.0%
3/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Eye disorders
Anterior Chamber Flare
|
6.7%
1/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.3%
1/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Eye disorders
Blepharospasm
|
6.7%
1/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
9.1%
1/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Eye disorders
Cataract
|
6.7%
1/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.8%
1/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
5.6%
1/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
9.1%
1/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Eye disorders
Conjunctival Oedema
|
6.7%
1/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Eye disorders
Conjunctivitis Allergic
|
6.7%
1/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.8%
1/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.3%
1/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Eye disorders
Corneal Disorder
|
6.7%
1/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Eye disorders
Erythema of Eyelid
|
6.7%
1/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.8%
1/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.8%
1/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
5.6%
1/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
8.7%
2/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Eye disorders
Eyelid Margin Crusting
|
6.7%
1/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Eye disorders
Eyelid Oedema
|
6.7%
1/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.8%
1/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
8.7%
2/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Eye disorders
Eyelid Pain
|
6.7%
1/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.3%
1/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Eye disorders
Eyelid Retraction
|
6.7%
1/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.8%
1/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Eye disorders
Eyelid Pruritus
|
6.7%
1/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Eye disorders
Lacrimation Increased
|
6.7%
1/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
23.8%
5/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
14.3%
3/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
5.6%
1/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
9.1%
1/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
17.4%
4/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Eye disorders
Macular Cyst
|
6.7%
1/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Eye disorders
Ocular Discomfort
|
6.7%
1/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.3%
1/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Eye disorders
Optic Disc Haemorrhage
|
6.7%
1/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Eye disorders
Retinal Vein Occlusion
|
6.7%
1/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Eye disorders
Blepharitis
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.8%
1/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
9.1%
1/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Eye disorders
Visual Acuity Reduced
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.8%
1/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.8%
1/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
11.1%
2/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
18.2%
2/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.3%
1/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Eye disorders
Anterior Chamber Inflammation
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
5.6%
1/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Eye disorders
Corneal Opacity
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
5.6%
1/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Eye disorders
Eye Irritation
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.8%
1/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
5.6%
1/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
8.7%
2/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Eye disorders
Eye Pruritus
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.8%
1/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
5.6%
1/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
17.4%
4/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Eye disorders
Iris Adhesions
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
5.6%
1/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.3%
1/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Eye disorders
Lid Margin Discharge
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
5.6%
1/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Eye disorders
Orbit Atrophy
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
5.6%
1/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Eye disorders
Retinal Detachment
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
5.6%
1/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Eye disorders
Corneal Oedema
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
9.1%
1/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.3%
1/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Eye disorders
Hyphaema
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
9.1%
1/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.3%
1/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Eye disorders
Iritis
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.8%
1/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
9.1%
1/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
8.7%
2/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Eye disorders
Lagophthalmos
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
9.1%
1/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Eye disorders
Posterior Capsule Opacification
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
9.1%
1/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.3%
1/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Eye disorders
Eyelid Ptosis
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.8%
1/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
13.0%
3/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Eye disorders
Vitreous Detachment
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.8%
1/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.8%
1/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
8.7%
2/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Investigations
Intraocular Pressure Increased
|
26.7%
4/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
9.5%
2/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
9.5%
2/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
5.6%
1/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
18.2%
2/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
8.7%
2/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Investigations
Blood Cholesterol Increased
|
6.7%
1/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.8%
1/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Investigations
Blood Lactate Dehydrogenase Increased
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
5.6%
1/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Investigations
Blood Pressure Increased
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.8%
1/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
5.6%
1/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Investigations
Gamma-glutamyltransferase Increased
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
5.6%
1/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Investigations
Blood Glucose Increased
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
9.1%
1/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.3%
1/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Investigations
Blood Potassium Decreased
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
9.1%
1/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Investigations
Heart Rate Irregular
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
9.1%
1/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Investigations
Blood Urine Present
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
8.7%
2/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Infections and infestations
Nasopharyngitis
|
20.0%
3/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.8%
1/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
16.7%
3/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.3%
1/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Infections and infestations
Influenza
|
6.7%
1/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
6.7%
1/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.8%
1/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
5.6%
1/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
9.1%
1/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.8%
1/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
11.1%
2/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
9.1%
1/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
8.7%
2/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
11.1%
2/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
9.1%
1/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
11.1%
2/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Infections and infestations
Ear Infection
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.8%
1/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.8%
1/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
5.6%
1/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
5.6%
1/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Infections and infestations
Escherichia Sepsis
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
9.1%
1/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Infections and infestations
Neutropenic Sepsis
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
9.1%
1/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Infections and infestations
Oesophageal Candidiasis
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
9.1%
1/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Infections and infestations
Progressive Multifocal Leukoencephalopathy
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
9.1%
1/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.7%
1/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.8%
1/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
8.7%
2/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
6.7%
1/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.3%
1/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
6.7%
1/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
9.5%
2/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.3%
1/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
5.6%
1/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
11.1%
2/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Spondylitis
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
5.6%
1/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
5.6%
1/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.8%
1/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
8.7%
2/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Nervous system disorders
Headache
|
13.3%
2/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.8%
1/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
9.1%
1/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.3%
1/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Nervous system disorders
Visual Field Defect
|
6.7%
1/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.8%
1/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
17.4%
4/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
11.1%
2/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
5.6%
1/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.7%
1/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.8%
1/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
18.2%
2/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.3%
1/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Gastrointestinal disorders
Large Intestine Polyp
|
6.7%
1/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.8%
1/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
9.5%
2/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
1/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.8%
1/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
9.1%
1/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
5.6%
1/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
9.1%
1/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Gastrointestinal disorders
Diverticulum Intestinal
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
9.1%
1/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.8%
1/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
9.1%
1/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Gastrointestinal disorders
Gastric Ulcer Haemorrhage
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
9.1%
1/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
9.1%
1/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
9.1%
1/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
9.1%
1/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
1/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
5.6%
1/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
9.1%
1/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.3%
1/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway Cough Syndrome
|
6.7%
1/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Sinusitis
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
5.6%
1/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
5.6%
1/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
5.6%
1/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
5.6%
1/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
9.1%
1/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Immune system disorders
Drug Hypersensitivity
|
6.7%
1/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
5.6%
1/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
8.7%
2/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Immune system disorders
Allergy to Arthropod Sting
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
9.1%
1/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
6.7%
1/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.3%
1/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
16.7%
3/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Injury, poisoning and procedural complications
Corneal Abrasion
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
11.1%
2/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
9.1%
1/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Injury, poisoning and procedural complications
Cervical Vertebral Fracture
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
5.6%
1/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Injury, poisoning and procedural complications
Facial Bones Fracture
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
5.6%
1/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Injury, poisoning and procedural complications
Joint Injury
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
5.6%
1/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Injury, poisoning and procedural complications
Tendon Rupture
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
5.6%
1/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Injury, poisoning and procedural complications
Upper Limb Fracture
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.8%
1/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Injury, poisoning and procedural complications
Transfusion Related Complication
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
9.1%
1/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Injury, poisoning and procedural complications
Aqueous Humour Leakage
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
13.0%
3/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.7%
1/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
5.6%
1/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.3%
1/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Skin and subcutaneous tissue disorders
Ingrowing Nail
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
9.1%
1/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Vascular disorders
Hypertension
|
6.7%
1/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.8%
1/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.3%
1/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
General disorders
Chest Pain
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
5.6%
1/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
General disorders
Pyrexia
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
5.6%
1/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
General disorders
Non-cardiac Chest Pain
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
9.1%
1/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Congenital, familial and genetic disorders
Corneal Dystrophy
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
5.6%
1/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.3%
1/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
5.6%
1/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
9.1%
1/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
13.0%
3/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.8%
1/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.3%
1/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.8%
1/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Melanoma
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
5.6%
1/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Renal and urinary disorders
Urinary Incontinence
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
5.6%
1/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
18.2%
2/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
9.1%
1/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Psychiatric disorders
Depression
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
9.1%
1/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
9.1%
1/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
9.1%
1/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
9.1%
1/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
9.1%
1/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Cardiac disorders
Atrioventricular Block
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
9.1%
1/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mantle Cell Lymphoma Stage IV
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
9.1%
1/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
8.7%
2/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Vascular disorders
Hypotension
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.8%
1/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/15
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
4.8%
1/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/21
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/18
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/11
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
0.00%
0/23
The Safety Population included all patients who received treatment and was used to assess adverse events and serious adverse events.
|
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