Trial Outcomes & Findings for Intravitreal LFG316 in Patients With Age-related Macular Degeneration (AMD) (NCT NCT01527500)
NCT ID: NCT01527500
Last Updated: 2021-01-05
Results Overview
Geographic atrophy (GA) lesion growth measured by fundus autofluorescence (FAF) from baseline to Day 505.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
158 participants
Primary outcome timeframe
Day 1 to Day 505 (starting from the day of first intravitreal injection until Day 505)
Results posted on
2021-01-05
Participant Flow
Study conducted in 2 parts: Part A \& Part B. Part A evaluated safety \& efficacy of multiple 5 mg/50 µL doses of intravitreal (IVT) LFG316 against sham every 28 days for 505 days Part B evaluated the safety and pharmacokinetics of a single IVT dose of 10 mg/100 µL of LFG316
Participant milestones
| Measure |
LFG316
|
Sham
|
|---|---|---|
|
Part B
STARTED
|
7
|
1
|
|
Part B
COMPLETED
|
6
|
1
|
|
Part B
NOT COMPLETED
|
1
|
0
|
|
Part A
STARTED
|
99
|
51
|
|
Part A
COMPLETED
|
69
|
38
|
|
Part A
NOT COMPLETED
|
30
|
13
|
Reasons for withdrawal
| Measure |
LFG316
|
Sham
|
|---|---|---|
|
Part A
Administrative
|
11
|
7
|
|
Part A
Adverse Event
|
4
|
2
|
|
Part A
Death
|
4
|
1
|
|
Part A
Lost to Follow-up
|
0
|
1
|
|
Part A
Protocol Deviation
|
9
|
2
|
|
Part A
Withdrawal by Subject
|
2
|
0
|
|
Part B
Adverse Event
|
1
|
0
|
Baseline Characteristics
Intravitreal LFG316 in Patients With Age-related Macular Degeneration (AMD)
Baseline characteristics by cohort
| Measure |
Part A- LFG316 5 mg
n=99 Participants
LFG316 5 mg injection every 28 days for a total of 12 injections
|
Part A- Sham
n=51 Participants
sham injection every 28 days for a total of 12 injections
|
Part B- LFG316 10 mg
n=7 Participants
Single LFG316 10 mg Injection
|
Part B- Sham
n=1 Participants
Single Sham injection
|
Total
n=158 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
78.6 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
80.8 years
STANDARD_DEVIATION 6.5 • n=7 Participants
|
84.1 years
STANDARD_DEVIATION 3.8 • n=5 Participants
|
81.0 years
STANDARD_DEVIATION NA • n=4 Participants
|
79.4 years
STANDARD_DEVIATION 7.2 • n=21 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
97 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
61 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 505 (starting from the day of first intravitreal injection until Day 505)Population: Pharmacodynamic analysis set (PD) which includes all patients with at least one dose of study drug and evaluable PD data.
Geographic atrophy (GA) lesion growth measured by fundus autofluorescence (FAF) from baseline to Day 505.
Outcome measures
| Measure |
LFG316
n=50 Participants
LFG316 (5 mg/50 µL)
|
Sham
n=27 Participants
Sham injection
|
LFG316 5 Mg-Sham
Difference in mean between LFG316 arm and Sham arm.
|
Sham - Part B
Single sham injection
|
|---|---|---|---|---|
|
Part A: Geographic Atrophy (GA) Lesion Growth Measured by Fundus Autofluorescence (FAF) From Baseline to Day 505
|
1.95 mm^2
Standard Deviation 1.01
|
1.58 mm^2
Standard Deviation 1.12
|
—
|
—
|
PRIMARY outcome
Timeframe: The primary objective was from Day 1 to Day 337, however data was captured to Day 505 as exploratory objectivePopulation: PD Set which included patients who had at least one dose of study drug and had evaluable PD Data.
Number is the Estimated Difference (95% CI) in lesion size.
Outcome measures
| Measure |
LFG316
n=50 Participants
LFG316 (5 mg/50 µL)
|
Sham
n=27 Participants
Sham injection
|
LFG316 5 Mg-Sham
n=77 Participants
Difference in mean between LFG316 arm and Sham arm.
|
Sham - Part B
Single sham injection
|
|---|---|---|---|---|
|
Part A: Sensitivity Analysis of the Primary End Point: Mixed Effects Model for Repeated Measurements on GA Lesion Growth Measured by Fundus Autoflourescence
Bilateral Day 169
|
0.975 mm^2
Interval 0.828 to 1.122
|
0.913 mm^2
Interval 0.712 to 1.114
|
0.062 mm^2
Interval -0.184 to 0.308
|
—
|
|
Part A: Sensitivity Analysis of the Primary End Point: Mixed Effects Model for Repeated Measurements on GA Lesion Growth Measured by Fundus Autoflourescence
Bilateral Day 337
|
1.825 mm^2
Interval 1.584 to 2.065
|
1.710 mm^2
Interval 1.379 to 2.041
|
0.115 mm^2
Interval -0.292 to 0.522
|
—
|
|
Part A: Sensitivity Analysis of the Primary End Point: Mixed Effects Model for Repeated Measurements on GA Lesion Growth Measured by Fundus Autoflourescence
Bilateral Day 505
|
2.674 mm^2
Interval 2.314 to 3.034
|
2.506 mm^2
Interval 2.012 to 3.001
|
0.168 mm^2
Interval -0.433 to 0.778
|
—
|
|
Part A: Sensitivity Analysis of the Primary End Point: Mixed Effects Model for Repeated Measurements on GA Lesion Growth Measured by Fundus Autoflourescence
Overall Day 169
|
1.036 mm^2
Interval 0.891 to 1.181
|
0.937 mm^2
Interval 0.718 to 1.156
|
0.099 mm^2
Interval -0.16 to 0.357
|
—
|
|
Part A: Sensitivity Analysis of the Primary End Point: Mixed Effects Model for Repeated Measurements on GA Lesion Growth Measured by Fundus Autoflourescence
Overall Day 337
|
1.885 mm^2
Interval 1.646 to 2.124
|
1.734 mm^2
Interval 1.397 to 2.07
|
0.152 mm^2
Interval -0.259 to 0.562
|
—
|
|
Part A: Sensitivity Analysis of the Primary End Point: Mixed Effects Model for Repeated Measurements on GA Lesion Growth Measured by Fundus Autoflourescence
Overall Day 505
|
2.735 mm^2
Interval 2.376 to 3.094
|
2.530 mm^2
Interval 2.035 to 3.025
|
0.205 mm^2
Interval -0.405 to 0.814
|
—
|
PRIMARY outcome
Timeframe: Day 1 to Day 85This primary outcome (for Part B) is reported under the Adverse Events section.
Outcome measures
| Measure |
LFG316
n=99 Participants
LFG316 (5 mg/50 µL)
|
Sham
n=51 Participants
Sham injection
|
LFG316 5 Mg-Sham
n=7 Participants
Difference in mean between LFG316 arm and Sham arm.
|
Sham - Part B
n=1 Participants
Single sham injection
|
|---|---|---|---|---|
|
Part B: Safety and Tolerability of a Single Intravitreal (IVT) Dose of 10 mg/100 μL of LFG316 in Patients With Advanced AMD).
Total # Affected by any Serious Adverse Event
|
27 number of patients
|
11 number of patients
|
1 number of patients
|
0 number of patients
|
|
Part B: Safety and Tolerability of a Single Intravitreal (IVT) Dose of 10 mg/100 μL of LFG316 in Patients With Advanced AMD).
Total # at Risk by any Serious Adverse Event
|
99 number of patients
|
51 number of patients
|
7 number of patients
|
1 number of patients
|
SECONDARY outcome
Timeframe: Day 1 to Day 169 and Day 505 (starting from the day of first intravitreal injection until Day 505)Population: PD Set which included patients who had at least one dose of study drug and had evaluable PD Data.
Mean change in GA lesion growth from baseline to Day 169 and Day 505.
Outcome measures
| Measure |
LFG316
n=74 Participants
LFG316 (5 mg/50 µL)
|
Sham
n=38 Participants
Sham injection
|
LFG316 5 Mg-Sham
Difference in mean between LFG316 arm and Sham arm.
|
Sham - Part B
Single sham injection
|
|---|---|---|---|---|
|
Part A: Change From Baseline in GA Lesions Growth Measured by Fundus Autofluorescence
Day 169 (n=68, 37)
|
0.99 mm^2
Standard Deviation 0.60
|
0.88 mm^2
Standard Deviation 0.77
|
—
|
—
|
|
Part A: Change From Baseline in GA Lesions Growth Measured by Fundus Autofluorescence
Day 505 (n=38, 18)
|
2.78 mm^2
Standard Deviation 1.28
|
2.03 mm^2
Standard Deviation 1.00
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline Day 1, Day 169, Day 337 to Day 505Population: PD analysis set which includes all patients with at least one dose of study drug and evaluable PD data.
Part A: Summary of best corrected visual acuity over time, statistical analysis of change in best corrected visual acuity over time Parameter: Visual Acuity (EDTRS letter) BCVA scale is 0-100, worst is 0 and best 100 Eye: STUDY
Outcome measures
| Measure |
LFG316
n=74 Participants
LFG316 (5 mg/50 µL)
|
Sham
n=38 Participants
Sham injection
|
LFG316 5 Mg-Sham
Difference in mean between LFG316 arm and Sham arm.
|
Sham - Part B
Single sham injection
|
|---|---|---|---|---|
|
Part A: Change in Best Corrected Visual Acuity (BCVA) as Measured by the EDTRS (Early Treatment of Diabetic Retinopathy Study) Scale From Baseline to Days 169, 337 & 505 in Patients Receiving Every 28 Days, Successive IVT Doses of LFG316 Compared to Sham
Baseline Day 1 (n=74, 38)
|
43.91 ETDRS letters
Standard Deviation 12.93
|
40.26 ETDRS letters
Standard Deviation 14.97
|
—
|
—
|
|
Part A: Change in Best Corrected Visual Acuity (BCVA) as Measured by the EDTRS (Early Treatment of Diabetic Retinopathy Study) Scale From Baseline to Days 169, 337 & 505 in Patients Receiving Every 28 Days, Successive IVT Doses of LFG316 Compared to Sham
Day 169 (n=71, 36)
|
48.38 ETDRS letters
Standard Deviation 11.05
|
42.50 ETDRS letters
Standard Deviation 15.14
|
—
|
—
|
|
Part A: Change in Best Corrected Visual Acuity (BCVA) as Measured by the EDTRS (Early Treatment of Diabetic Retinopathy Study) Scale From Baseline to Days 169, 337 & 505 in Patients Receiving Every 28 Days, Successive IVT Doses of LFG316 Compared to Sham
Day 337 (n=53, 30)
|
47.49 ETDRS letters
Standard Deviation 11.25
|
42.97 ETDRS letters
Standard Deviation 14.23
|
—
|
—
|
|
Part A: Change in Best Corrected Visual Acuity (BCVA) as Measured by the EDTRS (Early Treatment of Diabetic Retinopathy Study) Scale From Baseline to Days 169, 337 & 505 in Patients Receiving Every 28 Days, Successive IVT Doses of LFG316 Compared to Sham
Day 505 (n=40, 23)
|
44.73 ETDRS letters
Standard Deviation 11.29
|
43.78 ETDRS letters
Standard Deviation 14.11
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline Day 1, Day 169, Day 337 to Day 505Population: PD analysis set which includes all patients with at least one dose of study drug and evaluable PD data.
Part A: Summary of best corrected visual acuity over time, statistical analysis of change in best corrected visual acuity over time Parameter: Visual Acuity (EDTRS letter) BCVA scale is 0-100, worst is 0 and best 100 Eye: FELLOW
Outcome measures
| Measure |
LFG316
n=74 Participants
LFG316 (5 mg/50 µL)
|
Sham
n=38 Participants
Sham injection
|
LFG316 5 Mg-Sham
Difference in mean between LFG316 arm and Sham arm.
|
Sham - Part B
Single sham injection
|
|---|---|---|---|---|
|
Part A: Summary of Best Corrected Visual Acuity Over Time, Statistical Analysis of Change in Best Corrected Visual Acuity Over Time Parameter: Visual Acuity (EDTRS Letter) BCVA Scale is 0-100, Worst is 0 and Best 100 Eye: FELLOW
Baseline Day 1 (n=74, 38)
|
54.66 ETDRS Letters
Standard Deviation 22.02
|
55.13 ETDRS Letters
Standard Deviation 18.27
|
—
|
—
|
|
Part A: Summary of Best Corrected Visual Acuity Over Time, Statistical Analysis of Change in Best Corrected Visual Acuity Over Time Parameter: Visual Acuity (EDTRS Letter) BCVA Scale is 0-100, Worst is 0 and Best 100 Eye: FELLOW
Day 169 (n=71, 36)
|
54.59 ETDRS Letters
Standard Deviation 21.92
|
57.33 ETDRS Letters
Standard Deviation 17.89
|
—
|
—
|
|
Part A: Summary of Best Corrected Visual Acuity Over Time, Statistical Analysis of Change in Best Corrected Visual Acuity Over Time Parameter: Visual Acuity (EDTRS Letter) BCVA Scale is 0-100, Worst is 0 and Best 100 Eye: FELLOW
Day 337 (n=53, 30)
|
52.75 ETDRS Letters
Standard Deviation 21.66
|
53.87 ETDRS Letters
Standard Deviation 18.83
|
—
|
—
|
|
Part A: Summary of Best Corrected Visual Acuity Over Time, Statistical Analysis of Change in Best Corrected Visual Acuity Over Time Parameter: Visual Acuity (EDTRS Letter) BCVA Scale is 0-100, Worst is 0 and Best 100 Eye: FELLOW
Day 505 (n=40, 23)
|
50.95 ETDRS Letters
Standard Deviation 20.67
|
49.87 ETDRS Letters
Standard Deviation 19.35
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Day 559 (starting from the day of first intravitreal injection to day 559)Population: Pharmacokinetic analysis set: The PK analysis set included all patients with at least one dose of study drug and evaluable PK data.
Summary statistic of total LFG316 concentrations (pharmacokinetic analysis set) n=number of participants, h=hours after the last administered dose e.g.; 0.0 means just before dosing. If the mean concentration is 0.00, that means there is no drug in the bloodstream
Outcome measures
| Measure |
LFG316
n=99 Participants
LFG316 (5 mg/50 µL)
|
Sham
Sham injection
|
LFG316 5 Mg-Sham
Difference in mean between LFG316 arm and Sham arm.
|
Sham - Part B
Single sham injection
|
|---|---|---|---|---|
|
Part A: Concentrations of Total LFG316 in Blood During the Course of the Study
Day 1 (n=99), h=0
|
0.00 ng/mL
Standard Deviation 0.00
|
—
|
—
|
—
|
|
Part A: Concentrations of Total LFG316 in Blood During the Course of the Study
Day 1(n= 97), h= 24
|
293 ng/mL
Standard Deviation 332
|
—
|
—
|
—
|
|
Part A: Concentrations of Total LFG316 in Blood During the Course of the Study
Day 1(n=91), h=336
|
560 ng/mL
Standard Deviation 238
|
—
|
—
|
—
|
|
Part A: Concentrations of Total LFG316 in Blood During the Course of the Study
Day 29 (n=94), h=0
|
289 ng/mL
Standard Deviation 214
|
—
|
—
|
—
|
|
Part A: Concentrations of Total LFG316 in Blood During the Course of the Study
Day 57 (n=96), h=0
|
382 ng/mL
Standard Deviation 218
|
—
|
—
|
—
|
|
Part A: Concentrations of Total LFG316 in Blood During the Course of the Study
Day 85 (n=93), h=0
|
436 ng/mL
Standard Deviation 210
|
—
|
—
|
—
|
|
Part A: Concentrations of Total LFG316 in Blood During the Course of the Study
Day 113 (n=83), h=0
|
433 ng/mL
Standard Deviation 219
|
—
|
—
|
—
|
|
Part A: Concentrations of Total LFG316 in Blood During the Course of the Study
Day 141 (n=84), h=0
|
451 ng/mL
Standard Deviation 218
|
—
|
—
|
—
|
|
Part A: Concentrations of Total LFG316 in Blood During the Course of the Study
Day 141 (n=9), h=672
|
482 ng/mL
Standard Deviation 174
|
—
|
—
|
—
|
|
Part A: Concentrations of Total LFG316 in Blood During the Course of the Study
Day 169 (n=68), h=0
|
446 ng/mL
Standard Deviation 204
|
—
|
—
|
—
|
|
Part A: Concentrations of Total LFG316 in Blood During the Course of the Study
Day 197 (n=73), h=0
|
434 ng/mL
Standard Deviation 231
|
—
|
—
|
—
|
|
Part A: Concentrations of Total LFG316 in Blood During the Course of the Study
Day 225 (n=71), h=0
|
471 ng/mL
Standard Deviation 224
|
—
|
—
|
—
|
|
Part A: Concentrations of Total LFG316 in Blood During the Course of the Study
Day 253 (n=42), h=0
|
465 ng/mL
Standard Deviation 237
|
—
|
—
|
—
|
|
Part A: Concentrations of Total LFG316 in Blood During the Course of the Study
Day 281 (n=69), h=0
|
485 ng/mL
Standard Deviation 274
|
—
|
—
|
—
|
|
Part A: Concentrations of Total LFG316 in Blood During the Course of the Study
Day 309 (n=68), h=0
|
447 ng/mL
Standard Deviation 226
|
—
|
—
|
—
|
|
Part A: Concentrations of Total LFG316 in Blood During the Course of the Study
Day 309 (n=22), h=672
|
405 ng/mL
Standard Deviation 189
|
—
|
—
|
—
|
|
Part A: Concentrations of Total LFG316 in Blood During the Course of the Study
Day 365 (n=40), h=0
|
427 ng/mL
Standard Deviation 288
|
—
|
—
|
—
|
|
Part A: Concentrations of Total LFG316 in Blood During the Course of the Study
Day 393 (n=42), h=0
|
464 ng/mL
Standard Deviation 239
|
—
|
—
|
—
|
|
Part A: Concentrations of Total LFG316 in Blood During the Course of the Study
Day 421(n=40), h=0
|
471 ng/mL
Standard Deviation 228
|
—
|
—
|
—
|
|
Part A: Concentrations of Total LFG316 in Blood During the Course of the Study
Day 449 (n=40), h=0
|
459 ng/mL
Standard Deviation 214
|
—
|
—
|
—
|
|
Part A: Concentrations of Total LFG316 in Blood During the Course of the Study
Day 477 (n=39), h=0
|
422 ng/mL
Standard Deviation 236
|
—
|
—
|
—
|
|
Part A: Concentrations of Total LFG316 in Blood During the Course of the Study
Day 477 (n=41), h=672
|
439 ng/mL
Standard Deviation 191
|
—
|
—
|
—
|
|
Part A: Concentrations of Total LFG316 in Blood During the Course of the Study
Day 477 (n=38), h=1968
|
0.00 ng/mL
Standard Deviation 0.00
|
—
|
—
|
—
|
|
Part A: Concentrations of Total LFG316 in Blood During the Course of the Study
Day 309 (n=16), h=2688
|
0.00 ng/mL
Standard Deviation 0.00
|
—
|
—
|
—
|
|
Part A: Concentrations of Total LFG316 in Blood During the Course of the Study
Day 337 (n=42), h=0
|
435 ng/mL
Standard Deviation 283
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Day 559 (starting from the day of first intravitreal injection to day 559)Population: PD Analysis includes patients who received at least one dose of study drug with evaluable PD data.
Summary statistic of total C5 concentrations n=number of participants, h=scheduled sampling time
Outcome measures
| Measure |
LFG316
n=99 Participants
LFG316 (5 mg/50 µL)
|
Sham
n=51 Participants
Sham injection
|
LFG316 5 Mg-Sham
Difference in mean between LFG316 arm and Sham arm.
|
Sham - Part B
Single sham injection
|
|---|---|---|---|---|
|
Part A: Concentrations of Total C5 in Blood During the Course of the Study
Day 1 (n=99, 51), h=0
|
147000 ng/mL
Standard Deviation 28900
|
142000 ng/mL
Standard Deviation 25500
|
—
|
—
|
|
Part A: Concentrations of Total C5 in Blood During the Course of the Study
(n= 97, 51), h= 24
|
143000 ng/mL
Standard Deviation 31200
|
139000 ng/mL
Standard Deviation 27600
|
—
|
—
|
|
Part A: Concentrations of Total C5 in Blood During the Course of the Study
(n=91, 49), h=336
|
149000 ng/mL
Standard Deviation 41100
|
136000 ng/mL
Standard Deviation 25600
|
—
|
—
|
|
Part A: Concentrations of Total C5 in Blood During the Course of the Study
Day 29 (n=94, 47), h=0
|
145000 ng/mL
Standard Deviation 31200
|
142000 ng/mL
Standard Deviation 33900
|
—
|
—
|
|
Part A: Concentrations of Total C5 in Blood During the Course of the Study
Day 57 (n=96, 49), h=0
|
147000 ng/mL
Standard Deviation 29300
|
148000 ng/mL
Standard Deviation 40400
|
—
|
—
|
|
Part A: Concentrations of Total C5 in Blood During the Course of the Study
Day 85 (n=93, 46), h=0
|
154000 ng/mL
Standard Deviation 42500
|
144000 ng/mL
Standard Deviation 39100
|
—
|
—
|
|
Part A: Concentrations of Total C5 in Blood During the Course of the Study
Day 113 (n=83, 49), h=0
|
153000 ng/mL
Standard Deviation 46200
|
146000 ng/mL
Standard Deviation 42100
|
—
|
—
|
|
Part A: Concentrations of Total C5 in Blood During the Course of the Study
Day 141 (n=84, 45), h=0
|
144000 ng/mL
Standard Deviation 32600
|
141000 ng/mL
Standard Deviation 25600
|
—
|
—
|
|
Part A: Concentrations of Total C5 in Blood During the Course of the Study
(n=9, 3), h=672
|
146000 ng/mL
Standard Deviation 288000
|
135000 ng/mL
Standard Deviation 8000
|
—
|
—
|
|
Part A: Concentrations of Total C5 in Blood During the Course of the Study
Day 169 (n=68, 37), h=0
|
147000 ng/mL
Standard Deviation 39400
|
144000 ng/mL
Standard Deviation 38600
|
—
|
—
|
|
Part A: Concentrations of Total C5 in Blood During the Course of the Study
Day 197 (n=73, 36), h=0
|
143000 ng/mL
Standard Deviation 27300
|
139000 ng/mL
Standard Deviation 32500
|
—
|
—
|
|
Part A: Concentrations of Total C5 in Blood During the Course of the Study
Day 225 (n=71, 34), h=0
|
152000 ng/mL
Standard Deviation 51600
|
140000 ng/mL
Standard Deviation 33600
|
—
|
—
|
|
Part A: Concentrations of Total C5 in Blood During the Course of the Study
Day 253 (n=42, 18), h=0
|
144000 ng/mL
Standard Deviation 38500
|
129000 ng/mL
Standard Deviation 31000
|
—
|
—
|
|
Part A: Concentrations of Total C5 in Blood During the Course of the Study
Day 281 (n=69, 34), h=0
|
145000 ng/mL
Standard Deviation 28000
|
144000 ng/mL
Standard Deviation 35300
|
—
|
—
|
|
Part A: Concentrations of Total C5 in Blood During the Course of the Study
Day 309 (n=68, 32), h=0
|
151000 ng/mL
Standard Deviation 45200
|
148000 ng/mL
Standard Deviation 39400
|
—
|
—
|
|
Part A: Concentrations of Total C5 in Blood During the Course of the Study
(n=22, 12), h=672
|
137000 ng/mL
Standard Deviation 31000
|
145000 ng/mL
Standard Deviation 33200
|
—
|
—
|
|
Part A: Concentrations of Total C5 in Blood During the Course of the Study
Day 365 (n=40, 24), h=0
|
146000 ng/mL
Standard Deviation 29300
|
131000 ng/mL
Standard Deviation 29300
|
—
|
—
|
|
Part A: Concentrations of Total C5 in Blood During the Course of the Study
Day 393 (n=42, 22), h=0
|
145000 ng/mL
Standard Deviation 23700
|
132000 ng/mL
Standard Deviation 28500
|
—
|
—
|
|
Part A: Concentrations of Total C5 in Blood During the Course of the Study
Day 421(n=40, 22), h=0
|
149000 ng/mL
Standard Deviation 24700
|
141000 ng/mL
Standard Deviation 34200
|
—
|
—
|
|
Part A: Concentrations of Total C5 in Blood During the Course of the Study
Day 449 (n=40, 23), h=0
|
160000 ng/mL
Standard Deviation 41200
|
144000 ng/mL
Standard Deviation 27000
|
—
|
—
|
|
Part A: Concentrations of Total C5 in Blood During the Course of the Study
Day 477 (n=39, 21), h=0
|
148000 ng/mL
Standard Deviation 20400
|
156000 ng/mL
Standard Deviation 53900
|
—
|
—
|
|
Part A: Concentrations of Total C5 in Blood During the Course of the Study
(n=41, 21), h=672
|
158000 ng/mL
Standard Deviation 37800
|
155000 ng/mL
Standard Deviation 59000
|
—
|
—
|
|
Part A: Concentrations of Total C5 in Blood During the Course of the Study
(n=38, 22), h=1968
|
198000 ng/mL
Standard Deviation 82700
|
186000 ng/mL
Standard Deviation 79600
|
—
|
—
|
|
Part A: Concentrations of Total C5 in Blood During the Course of the Study
Day 309 (n=16, 10), h=2688
|
135000 ng/mL
Standard Deviation 19600
|
135000 ng/mL
Standard Deviation 18800
|
—
|
—
|
|
Part A: Concentrations of Total C5 in Blood During the Course of the Study
Day 337 (n=44, 24), h-0
|
147000 ng/mL
Standard Deviation 27900
|
137000 ng/mL
Standard Deviation 36200
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Day 85 (starting from the day of first intravitreal injection to day 85)Population: Pharmacokinetic analysis set: The PK analysis set included all patients with at least one dose of study drug and evaluable PK data.
Summary statistic of total LFG316 concentrations (pharmacokinetic analysis set) n=number of participants, h=scheduled sampling time
Outcome measures
| Measure |
LFG316
n=7 Participants
LFG316 (5 mg/50 µL)
|
Sham
Sham injection
|
LFG316 5 Mg-Sham
Difference in mean between LFG316 arm and Sham arm.
|
Sham - Part B
Single sham injection
|
|---|---|---|---|---|
|
Part B: AUC (Area Under the Curve) - Summary Statistics for PK Parameters
AUCall (hr*ng/mL)
|
743000 hr*ng/mL
Standard Deviation 241000
|
—
|
—
|
—
|
|
Part B: AUC (Area Under the Curve) - Summary Statistics for PK Parameters
AUClast (hr*ng/mL)
|
600000 hr*ng/mL
Standard Deviation 212000
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Day 85 (starting from the day of first intravitreal injection to day 85)Population: Pharmacokinetic analysis set: The PK analysis set included all patients with at least one dose of study drug and evaluable PK data.
PART B: Tmax (Time of Maximum concentration observed) This is the highest concentration of drug in the blood that is measured after a dose. Cmax usually happens within a few hours after the dose is taken. The time that Cmax happens is referred to as Tmax. For some antiretroviral drugs, a high Cmax is thought to increase the risk of side effects from the drug.
Outcome measures
| Measure |
LFG316
n=7 Participants
LFG316 (5 mg/50 µL)
|
Sham
Sham injection
|
LFG316 5 Mg-Sham
Difference in mean between LFG316 arm and Sham arm.
|
Sham - Part B
Single sham injection
|
|---|---|---|---|---|
|
Tmax (hr)
|
213 hours
Interval 119.0 to 311.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Day 85 (starting from the day of first intravitreal injection to day 85)Population: Pharmacokinetic analysis set: The PK analysis set included all patients with at least one dose of study drug and evaluable PK data.
Summary statistic for Part B of total LFG316 concentrations (pharmacokinetic analysis set) Cmax is the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated and before the administration of a second dose
Outcome measures
| Measure |
LFG316
n=7 Participants
LFG316 (5 mg/50 µL)
|
Sham
Sham injection
|
LFG316 5 Mg-Sham
Difference in mean between LFG316 arm and Sham arm.
|
Sham - Part B
Single sham injection
|
|---|---|---|---|---|
|
Part B: Cmax - Summary Statistic for PK Parameters
|
1010 ng/mL
Standard Deviation 213
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Day 85 (starting from the day of first intravitreal injection to day 85)Population: Pharmacokinetic analysis set: The PK analysis set included all patients with at least one dose of study drug and evaluable PK data.
Cmax\_D=ng/mL/mg
Outcome measures
| Measure |
LFG316
n=7 Participants
LFG316 (5 mg/50 µL)
|
Sham
Sham injection
|
LFG316 5 Mg-Sham
Difference in mean between LFG316 arm and Sham arm.
|
Sham - Part B
Single sham injection
|
|---|---|---|---|---|
|
Part B: Cmax_D - Summary Statistic for PK Parameters
|
101 ng/mL/mg
Standard Deviation 21.3
|
—
|
—
|
—
|
Adverse Events
Part A - LFG316 5mg
Serious events: 27 serious events
Other events: 98 other events
Deaths: 0 deaths
Part A - Sham
Serious events: 11 serious events
Other events: 42 other events
Deaths: 0 deaths
Part B - LFG316 10mg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Part B - Sham
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A - LFG316 5mg
n=99 participants at risk
Part A - LFG316 5 mg/50 µL injection every 4 weeks for 18 months
|
Part A - Sham
n=51 participants at risk
sham injection every 4 weeks for a total of 18 injections
|
Part B - LFG316 10mg
n=7 participants at risk
Part B - Single LFG316 10 mg/100 µL injection
|
Part B - Sham
n=1 participants at risk
single sham injection
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Blood and lymphatic system disorders
Immune thrombocytopenic purpura
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Cardiac disorders
Angina pectoris
|
1.0%
1/99
|
3.9%
2/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Cardiac disorders
Atrial fibrillation
|
1.0%
1/99
|
0.00%
0/51
|
14.3%
1/7
|
0.00%
0/1
|
|
Cardiac disorders
Atrioventricular block second degree
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Cardiac disorders
Cardiac failure congestive
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Cardiac disorders
Cardiomyopathy
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Cardiac disorders
Coronary artery disease
|
2.0%
2/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Ear and labyrinth disorders
Vertigo
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Visual acuity reduced (Fellow Eye)
|
1.0%
1/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Visual acuity reduced (Study Eye)
|
1.0%
1/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.0%
2/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Gastrointestinal disorders
Constipation
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/99
|
0.00%
0/51
|
14.3%
1/7
|
0.00%
0/1
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Gastrointestinal disorders
Umbilical hernia
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Gastrointestinal disorders
Vomiting
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
General disorders
Non-cardiac chest pain
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Infections and infestations
Cellulitis
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Infections and infestations
Clostridium difficile infection
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Infections and infestations
Cystitis
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Infections and infestations
Endophthalmitis (Study Eye)
|
2.0%
2/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Infections and infestations
Pneumonia
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Infections and infestations
Urinary tract infection
|
2.0%
2/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Injury, poisoning and procedural complications
Auricular haematoma
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Investigations
International normalised ratio increased
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Dehydration
|
1.0%
1/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.0%
1/99
|
0.00%
0/51
|
14.3%
1/7
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Nervous system disorders
Dizziness
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Psychiatric disorders
Confusional state
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Psychiatric disorders
Delirium
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Renal and urinary disorders
Acute prerenal failure
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Renal and urinary disorders
Haematuria
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.0%
1/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Lung consolidation
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Vascular disorders
Haemorrhage
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Vascular disorders
Hypertension
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Vascular disorders
Temporal arteritis
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
Other adverse events
| Measure |
Part A - LFG316 5mg
n=99 participants at risk
Part A - LFG316 5 mg/50 µL injection every 4 weeks for 18 months
|
Part A - Sham
n=51 participants at risk
sham injection every 4 weeks for a total of 18 injections
|
Part B - LFG316 10mg
n=7 participants at risk
Part B - Single LFG316 10 mg/100 µL injection
|
Part B - Sham
n=1 participants at risk
single sham injection
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.1%
6/99
|
5.9%
3/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Blood and lymphatic system disorders
Macrocytosis
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Cardiac disorders
Angina pectoris
|
2.0%
2/99
|
3.9%
2/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Cardiac disorders
Arrhythmia
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Cardiac disorders
Atrial fibrillation
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Cardiac disorders
Bradycardia
|
1.0%
1/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Cardiac disorders
Cardiac failure congestive
|
1.0%
1/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Cardiac disorders
Coronary artery disease
|
2.0%
2/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Cardiac disorders
Heart valve incompetence
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Cardiac disorders
Tachycardia
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Cardiac disorders
Ventricular extrasystoles
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Congenital, familial and genetic disorders
Corneal dystrophy (Fellow Eye)
|
0.00%
0/99
|
0.00%
0/51
|
14.3%
1/7
|
0.00%
0/1
|
|
Congenital, familial and genetic disorders
Corneal dystrophy (Study Eye)
|
0.00%
0/99
|
0.00%
0/51
|
14.3%
1/7
|
0.00%
0/1
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Ear and labyrinth disorders
Ear pain
|
2.0%
2/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Ear and labyrinth disorders
Vertigo
|
2.0%
2/99
|
3.9%
2/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Endocrine disorders
Hypothyroidism
|
4.0%
4/99
|
3.9%
2/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Anterior chamber cell (Study Eye)
|
3.0%
3/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Anterior chamber flare (Study Eye)
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Blepharitis (Fellow Eye)
|
2.0%
2/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Blepharitis (Study Eye)
|
4.0%
4/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Blepharitis allergic (Study Eye)
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Blepharospasm (Study Eye)
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Cataract (Fellow Eye)
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Cataract (Study Eye)
|
2.0%
2/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Cataract nuclear (Fellow Eye)
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Cataract nuclear (Study Eye)
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Cataract subcapsular (Fellow Eye)
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Cataract subcapsular (Study Eye)
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Charles Bonnet syndrome
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Charles Bonnet syndrome (Fellow Eye)
|
0.00%
0/99
|
2.0%
1/51
|
14.3%
1/7
|
0.00%
0/1
|
|
Eye disorders
Charles Bonnet syndrome (Study Eye)
|
0.00%
0/99
|
2.0%
1/51
|
14.3%
1/7
|
0.00%
0/1
|
|
Eye disorders
Chorioretinal atrophy (Fellow Eye)
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Chorioretinal atrophy (Study Eye)
|
2.0%
2/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Choroidal neovascularisation (Fellow Eye)
|
1.0%
1/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Choroidal neovascularisation (Study Eye)
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Conjunctival haemorrhage (Fellow Eye)
|
1.0%
1/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Conjunctival haemorrhage (Study Eye)
|
70.7%
70/99
|
56.9%
29/51
|
28.6%
2/7
|
0.00%
0/1
|
|
Eye disorders
Conjunctival hyperaemia (Study Eye)
|
3.0%
3/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Conjunctival oedema (Study Eye)
|
2.0%
2/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Conjunctival vascular disorder (Study Eye)
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Corneal deposits (Study Eye)
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Corneal oedema (Study Eye)
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Corneal opacity (Study Eye)
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Corneal scar (Study Eye)
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Diplopia (Fellow Eye)
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Diplopia (Study Eye)
|
1.0%
1/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Dry eye (Fellow Eye)
|
5.1%
5/99
|
3.9%
2/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Dry eye (Study Eye)
|
5.1%
5/99
|
5.9%
3/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Ectropion (Study Eye)
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Erythema of eyelid (Study Eye)
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Exfoliation glaucoma (Study Eye)
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Eye colour change (Study Eye)
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Eye inflammation (Study Eye)
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Eye irritation (Fellow Eye)
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Eye irritation (Study Eye)
|
11.1%
11/99
|
9.8%
5/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Eye pain (Fellow Eye)
|
2.0%
2/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Eye pain (Study Eye)
|
12.1%
12/99
|
11.8%
6/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Eye pruritus (Fellow Eye)
|
2.0%
2/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Eye pruritus (Study Eye)
|
4.0%
4/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Eye swelling (Study Eye)
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Eyelid irritation (Study Eye)
|
2.0%
2/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Eyelid oedema (Study Eye)
|
2.0%
2/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Eyelids pruritus (Study Eye)
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Foreign body sensation in eyes (Study Eye)
|
10.1%
10/99
|
13.7%
7/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Glaucoma (Fellow Eye)
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Glaucoma (Study Eye)
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Hyphaema (Study Eye)
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Iritis (Study Eye)
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Keratitis (Study Eye)
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Lacrimation decreased (Study Eye)
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Lacrimation increased (Study Eye)
|
6.1%
6/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Macular degeneration (Fellow Eye)
|
1.0%
1/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Macular oedema (Study Eye)
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Neovascular age-related macular degeneration (Fellow Eye)
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Neovascular age-related macular degeneration (Study Eye)
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Ocular discomfort (Study Eye)
|
4.0%
4/99
|
3.9%
2/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Ocular hyperaemia (Study Eye)
|
2.0%
2/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Optic disc disorder (Study Eye)
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Optic disc haemorrhage (Fellow Eye)
|
2.0%
2/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Photophobia (Fellow Eye)
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Photophobia (Study Eye)
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Photopsia (Study Eye)
|
1.0%
1/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Posterior capsule opacification (Fellow Eye)
|
4.0%
4/99
|
3.9%
2/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Posterior capsule opacification (Study Eye)
|
3.0%
3/99
|
3.9%
2/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Pterygium (Study Eye)
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Punctate keratitis (Study Eye)
|
4.0%
4/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Refraction disorder (Fellow Eye)
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Refraction disorder (Study Eye)
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Retinal haemorrhage (Fellow Eye)
|
2.0%
2/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Retinal haemorrhage (Study Eye)
|
1.0%
1/99
|
0.00%
0/51
|
14.3%
1/7
|
0.00%
0/1
|
|
Eye disorders
Retinal pigment epitheliopathy (Fellow Eye)
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Retinal pigment epitheliopathy (Study Eye)
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Retinal tear (Study Eye)
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Scleral hyperaemia (Study Eye)
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Subretinal fluid (Fellow Eye)
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Trichiasis (Study Eye)
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Ulcerative keratitis (Study Eye)
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Uveitis (Study Eye)
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Vision blurred (Fellow Eye)
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Vision blurred (Study Eye)
|
1.0%
1/99
|
5.9%
3/51
|
0.00%
0/7
|
100.0%
1/1
|
|
Eye disorders
Visual acuity reduced (Fellow Eye)
|
3.0%
3/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Visual acuity reduced (Study Eye)
|
7.1%
7/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Visual acuity reduced transiently (Fellow Eye)
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Visual acuity reduced transiently (Study Eye)
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Visual brightness (Fellow Eye)
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Visual brightness (Study Eye)
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Visual impairment (Study Eye)
|
3.0%
3/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Vitreous detachment
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Vitreous detachment (Fellow Eye)
|
1.0%
1/99
|
5.9%
3/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Vitreous detachment (Study Eye)
|
10.1%
10/99
|
3.9%
2/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Vitreous disorder (Study Eye)
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Vitreous floaters (Fellow Eye)
|
3.0%
3/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Vitreous floaters (Study Eye)
|
24.2%
24/99
|
2.0%
1/51
|
14.3%
1/7
|
0.00%
0/1
|
|
Eye disorders
Vitreous haemorrhage (Fellow Eye)
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Vitreous haemorrhage (Study Eye)
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Eye disorders
Vitreous opacities (Study Eye)
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Gastrointestinal disorders
Abdominal pain
|
2.0%
2/99
|
3.9%
2/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Gastrointestinal disorders
Constipation
|
6.1%
6/99
|
5.9%
3/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Gastrointestinal disorders
Diarrhoea
|
4.0%
4/99
|
5.9%
3/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Gastrointestinal disorders
Gastric ulcer
|
2.0%
2/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Gastrointestinal disorders
Haematemesis
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Gastrointestinal disorders
Nausea
|
9.1%
9/99
|
5.9%
3/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Gastrointestinal disorders
Tooth deposit
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Gastrointestinal disorders
Toothache
|
2.0%
2/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Gastrointestinal disorders
Vomiting
|
5.1%
5/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
General disorders
Application site pain (Study Eye)
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
General disorders
Asthenia
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
General disorders
Chest discomfort
|
2.0%
2/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
General disorders
Chills
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
General disorders
Facial pain
|
1.0%
1/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
General disorders
Fatigue
|
1.0%
1/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
General disorders
Fibrosis (Study Eye)
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
General disorders
Injection site bruising (Study Eye)
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
General disorders
Injection site erythema (Study Eye)
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
General disorders
Injection site irritation (Study Eye)
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
General disorders
Injection site reaction (Study Eye)
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
General disorders
Non-cardiac chest pain
|
1.0%
1/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
General disorders
Oedema peripheral
|
6.1%
6/99
|
5.9%
3/51
|
0.00%
0/7
|
0.00%
0/1
|
|
General disorders
Pain
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
General disorders
Peripheral swelling
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
General disorders
Pyrexia
|
1.0%
1/99
|
3.9%
2/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Immune system disorders
Allergy to arthropod bite
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Immune system disorders
Allergy to chemicals
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Immune system disorders
Drug hypersensitivity
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Immune system disorders
Hypersensitivity
|
4.0%
4/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Infections and infestations
Acute sinusitis
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Infections and infestations
Bronchitis
|
8.1%
8/99
|
7.8%
4/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Infections and infestations
Cellulitis
|
3.0%
3/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Infections and infestations
Conjunctivitis (Fellow Eye)
|
2.0%
2/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Infections and infestations
Conjunctivitis (Study Eye)
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Infections and infestations
Cystitis
|
3.0%
3/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Infections and infestations
Diverticulitis
|
2.0%
2/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Infections and infestations
Ear infection
|
2.0%
2/99
|
3.9%
2/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Infections and infestations
Eye infection staphylococcal (Study Eye)
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Infections and infestations
Fungal skin infection
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Infections and infestations
Furuncle
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Infections and infestations
Herpes zoster
|
1.0%
1/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Infections and infestations
Hordeolum (Fellow Eye)
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Infections and infestations
Influenza
|
2.0%
2/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Infections and infestations
Kidney infection
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Infections and infestations
Laryngitis
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Infections and infestations
Localised infection
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Infections and infestations
Nasopharyngitis
|
9.1%
9/99
|
7.8%
4/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Infections and infestations
Oral candidiasis
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Infections and infestations
Otitis media acute
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Infections and infestations
Paronychia
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Infections and infestations
Periodontitis
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Infections and infestations
Pneumonia
|
2.0%
2/99
|
5.9%
3/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Infections and infestations
Rhinitis
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Infections and infestations
Sinusitis
|
3.0%
3/99
|
3.9%
2/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Infections and infestations
Tooth abscess
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Infections and infestations
Tooth infection
|
0.00%
0/99
|
3.9%
2/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Infections and infestations
Upper respiratory tract infection
|
13.1%
13/99
|
7.8%
4/51
|
0.00%
0/7
|
100.0%
1/1
|
|
Infections and infestations
Urinary tract infection
|
3.0%
3/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Infections and infestations
Wound infection
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Injury, poisoning and procedural complications
Contusion
|
2.0%
2/99
|
5.9%
3/51
|
0.00%
0/7
|
100.0%
1/1
|
|
Injury, poisoning and procedural complications
Corneal abrasion (Study Eye)
|
2.0%
2/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Injury, poisoning and procedural complications
Fall
|
6.1%
6/99
|
5.9%
3/51
|
0.00%
0/7
|
100.0%
1/1
|
|
Injury, poisoning and procedural complications
Hand fracture
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Injury, poisoning and procedural complications
Joint injury
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Injury, poisoning and procedural complications
Laceration
|
1.0%
1/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
1.0%
1/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Injury, poisoning and procedural complications
Muscle injury
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/99
|
3.9%
2/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Injury, poisoning and procedural complications
Post procedural complication (Study Eye)
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Injury, poisoning and procedural complications
Post procedural discomfort (Study Eye)
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Injury, poisoning and procedural complications
Procedural headache
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Injury, poisoning and procedural complications
Procedural pain
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Injury, poisoning and procedural complications
Procedural pain (Study Eye)
|
2.0%
2/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Injury, poisoning and procedural complications
Rib fracture
|
3.0%
3/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Injury, poisoning and procedural complications
Skin injury
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Injury, poisoning and procedural complications
Thermal burn
|
2.0%
2/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Investigations
Blood cholesterol increased
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Investigations
Blood creatinine increased
|
2.0%
2/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Investigations
Blood glucose increased
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Investigations
Blood pressure increased
|
1.0%
1/99
|
3.9%
2/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Investigations
Blood triglycerides increased
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Investigations
Blood urea increased
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Investigations
Cardiac murmur
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Investigations
Crystal urine present
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Investigations
Electrocardiogram T wave abnormal
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Investigations
Haematocrit decreased
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Investigations
Haemoglobin decreased
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Investigations
Haemoglobin increased
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Investigations
Heart rate irregular
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Investigations
Intraocular pressure increased (Fellow Eye)
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Investigations
Intraocular pressure increased (Study Eye)
|
4.0%
4/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Investigations
Red blood cell count decreased
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Investigations
Red blood cell count increased
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Investigations
Red blood cells urine
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Investigations
Transaminases increased
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Investigations
Urine leukocyte esterase positive
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Investigations
Visual acuity tests abnormal (Study Eye)
|
0.00%
0/99
|
0.00%
0/51
|
14.3%
1/7
|
0.00%
0/1
|
|
Investigations
Weight decreased
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Investigations
White blood cell count decreased
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Investigations
White blood cells urine positive
|
0.00%
0/99
|
3.9%
2/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
2.0%
2/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Gout
|
1.0%
1/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
1.0%
1/99
|
0.00%
0/51
|
14.3%
1/7
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
3.0%
3/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.0%
1/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.0%
2/99
|
5.9%
3/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.0%
3/99
|
5.9%
3/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Fracture pain
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.0%
2/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic fracture
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.0%
4/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Tendon pain
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
1.0%
1/99
|
3.9%
2/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
2.0%
2/99
|
3.9%
2/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign breast neoplasm
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of eyelid (Fellow Eye)
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Eye naevus (Fellow Eye)
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Nervous system disorders
Dizziness
|
6.1%
6/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Nervous system disorders
Dysaesthesia
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Nervous system disorders
Head discomfort
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Nervous system disorders
Headache
|
5.1%
5/99
|
5.9%
3/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Nervous system disorders
Hyporeflexia
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Nervous system disorders
Lumbar radiculopathy
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Nervous system disorders
Memory impairment
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Nervous system disorders
Nerve compression
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Nervous system disorders
Neuropathy peripheral
|
1.0%
1/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Nervous system disorders
Presyncope
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Nervous system disorders
Sciatica
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Nervous system disorders
Visual field defect (Fellow Eye)
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Psychiatric disorders
Depression
|
2.0%
2/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Psychiatric disorders
Insomnia
|
2.0%
2/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Renal and urinary disorders
Acute kidney injury
|
1.0%
1/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Renal and urinary disorders
Bladder outlet obstruction
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Renal and urinary disorders
Calculus bladder
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Renal and urinary disorders
Chronic kidney disease
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Renal and urinary disorders
Haematuria
|
2.0%
2/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Renal and urinary disorders
Nocturia
|
2.0%
2/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Renal and urinary disorders
Pelvi-ureteric obstruction
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Renal and urinary disorders
Urethral stenosis
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Renal and urinary disorders
Urinary incontinence
|
2.0%
2/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Reproductive system and breast disorders
Calculus prostatic
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Reproductive system and breast disorders
Prostatic calcification
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Reproductive system and breast disorders
Prostatic haemorrhage
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Reproductive system and breast disorders
Prostatomegaly
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Allergic cough
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.0%
1/99
|
5.9%
3/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
2/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.0%
3/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.0%
1/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/99
|
3.9%
2/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.0%
2/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Tracheomalacia
|
0.00%
0/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
1.0%
1/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
Cutis laxa (Fellow Eye)
|
2.0%
2/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
Cutis laxa (Study Eye)
|
2.0%
2/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
2.0%
2/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
Ecchymosis (Study Eye)
|
2.0%
2/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
Precancerous skin lesion
|
0.00%
0/99
|
3.9%
2/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Vascular disorders
Deep vein thrombosis
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Vascular disorders
Haematoma
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Vascular disorders
Hypertension
|
9.1%
9/99
|
5.9%
3/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Vascular disorders
Hypotension
|
1.0%
1/99
|
2.0%
1/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Vascular disorders
Labile hypertension
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
|
Vascular disorders
Poor peripheral circulation
|
1.0%
1/99
|
0.00%
0/51
|
0.00%
0/7
|
0.00%
0/1
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial
- Publication restrictions are in place
Restriction type: OTHER