Trial Outcomes & Findings for Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration (AMD) (NCT NCT00637377)
NCT ID: NCT00637377
Last Updated: 2014-12-12
Results Overview
Maintenance of vision was defined as a loss of \< 15 letters in the ETDRS (Early Treatment Diabetic Retinopathy Study) letter score (defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 25 (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision \* 100); Denominator = Number of participants analyzed.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1240 participants
Primary outcome timeframe
At week 52
Results posted on
2014-12-12
Participant Flow
The study was conducted at 186 study centers in 26 countries. Recruitment period: 21 Apr 2008 - 4 Sep 2009.
2031 participants were screened, 1240 were randomized and 1204 received at least 1 dose of study drug. 1204 participants were included in the Safety-Analysis Set (SAS). 1202 participants with at least 1 post-baseline measurement were included in the Full-Analysis Set (FAS).
Participant milestones
| Measure |
Ranibizumab 0.5mg Q4
Participants received a dose of 0.5 mg Ranibizumab every 4 weeks for the first year (intravitreal \[IVT\] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
|
Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4
Participants received a dose of 2.0 mg Aflibercept Injection every 4 weeks for the first year (intravitreal \[IVT\] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
|
Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4
Participants received a dose of 0.5 mg Aflibercept Injection every 4 weeks for the first year (intravitreal \[IVT\] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
|
Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8
Participants received a dose of 2.0 mg Aflibercept Injection every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year (IVT injection) and were to receive sham injections at interim monthly visits. During the second year, participants received 2.0 mg aflibercept as frequently as every 4 weeks, but no less frequently than every 12 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
303
|
313
|
311
|
313
|
|
Overall Study
Participants Received Treatment
|
291
|
309
|
297
|
307
|
|
Overall Study
Participants Treated (FAS)
|
291
|
309
|
296
|
306
|
|
Overall Study
COMPLETED
|
276
|
281
|
274
|
284
|
|
Overall Study
NOT COMPLETED
|
27
|
32
|
37
|
29
|
Reasons for withdrawal
| Measure |
Ranibizumab 0.5mg Q4
Participants received a dose of 0.5 mg Ranibizumab every 4 weeks for the first year (intravitreal \[IVT\] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
|
Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4
Participants received a dose of 2.0 mg Aflibercept Injection every 4 weeks for the first year (intravitreal \[IVT\] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
|
Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4
Participants received a dose of 0.5 mg Aflibercept Injection every 4 weeks for the first year (intravitreal \[IVT\] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
|
Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8
Participants received a dose of 2.0 mg Aflibercept Injection every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year (IVT injection) and were to receive sham injections at interim monthly visits. During the second year, participants received 2.0 mg aflibercept as frequently as every 4 weeks, but no less frequently than every 12 weeks.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
6
|
8
|
9
|
|
Overall Study
Death
|
1
|
3
|
2
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
4
|
1
|
2
|
2
|
|
Overall Study
Protocol Violation
|
2
|
1
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
11
|
15
|
13
|
11
|
|
Overall Study
Other (no further information available)
|
7
|
6
|
10
|
5
|
Baseline Characteristics
Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration (AMD)
Baseline characteristics by cohort
| Measure |
Ranibizumab 0.5mg Q4
n=291 Participants
Participants received a dose of 0.5 mg Ranibizumab every 4 weeks for the first year (intravitreal \[IVT\] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
|
Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4
n=309 Participants
Participants received a dose of 2.0 mg Aflibercept Injection every 4 weeks for the first year (intravitreal \[IVT\] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
|
Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4
n=296 Participants
Participants received a dose of 0.5 mg Aflibercept Injection every 4 weeks for the first year (intravitreal \[IVT\] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
|
Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8
n=306 Participants
Participants received a dose of 2.0 mg Aflibercept Injection every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year (IVT injection) and were to receive sham injections at interim monthly visits. During the second year, participants received 2.0 mg aflibercept as frequently as every 4 weeks, but no less frequently than every 12 weeks.
|
Total
n=1202 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
73.0 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
74.1 years
STANDARD_DEVIATION 8.5 • n=7 Participants
|
74.7 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
73.8 years
STANDARD_DEVIATION 8.6 • n=4 Participants
|
73.9 years
STANDARD_DEVIATION 8.7 • n=21 Participants
|
|
Sex: Female, Male
Female
|
169 Participants
n=5 Participants
|
176 Participants
n=7 Participants
|
147 Participants
n=5 Participants
|
175 Participants
n=4 Participants
|
667 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
122 Participants
n=5 Participants
|
133 Participants
n=7 Participants
|
149 Participants
n=5 Participants
|
131 Participants
n=4 Participants
|
535 Participants
n=21 Participants
|
|
Ethnicity
Not Hispanic or Latino
|
239 participants
n=5 Participants
|
259 participants
n=7 Participants
|
241 participants
n=5 Participants
|
251 participants
n=4 Participants
|
990 participants
n=21 Participants
|
|
Ethnicity
Hispanic or Latino
|
52 participants
n=5 Participants
|
50 participants
n=7 Participants
|
55 participants
n=5 Participants
|
55 participants
n=4 Participants
|
212 participants
n=21 Participants
|
|
Race
White
|
213 participants
n=5 Participants
|
226 participants
n=7 Participants
|
219 participants
n=5 Participants
|
217 participants
n=4 Participants
|
875 participants
n=21 Participants
|
|
Race
Black or African American
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
4 participants
n=21 Participants
|
|
Race
Asian
|
60 participants
n=5 Participants
|
67 participants
n=7 Participants
|
61 participants
n=5 Participants
|
69 participants
n=4 Participants
|
257 participants
n=21 Participants
|
|
Race
Missing
|
17 participants
n=5 Participants
|
16 participants
n=7 Participants
|
15 participants
n=5 Participants
|
18 participants
n=4 Participants
|
66 participants
n=21 Participants
|
|
National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) total score
|
72.90 scores on a scale
STANDARD_DEVIATION 19.09 • n=5 Participants
|
70.27 scores on a scale
STANDARD_DEVIATION 19.41 • n=7 Participants
|
74.04 scores on a scale
STANDARD_DEVIATION 18.22 • n=5 Participants
|
71.30 scores on a scale
STANDARD_DEVIATION 19.06 • n=4 Participants
|
72.10 scores on a scale
STANDARD_DEVIATION 18.99 • n=21 Participants
|
|
Area of Choroidal Neovascularization (CNV)
|
7.59 mm^2
STANDARD_DEVIATION 5.34 • n=5 Participants
|
8.25 mm^2
STANDARD_DEVIATION 5.77 • n=7 Participants
|
7.70 mm^2
STANDARD_DEVIATION 5.26 • n=5 Participants
|
7.75 mm^2
STANDARD_DEVIATION 5.52 • n=4 Participants
|
7.83 mm^2
STANDARD_DEVIATION 5.48 • n=21 Participants
|
|
Baseline lesion type
Predominantly classic
|
70 participants
n=5 Participants
|
72 participants
n=7 Participants
|
80 participants
n=5 Participants
|
88 participants
n=4 Participants
|
310 participants
n=21 Participants
|
|
Baseline lesion type
Minimally classic
|
104 participants
n=5 Participants
|
112 participants
n=7 Participants
|
103 participants
n=5 Participants
|
106 participants
n=4 Participants
|
425 participants
n=21 Participants
|
|
Baseline lesion type
Occult
|
116 participants
n=5 Participants
|
123 participants
n=7 Participants
|
113 participants
n=5 Participants
|
110 participants
n=4 Participants
|
462 participants
n=21 Participants
|
|
Baseline lesion type
Missing
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
5 participants
n=21 Participants
|
|
Baseline total lesion size
|
8.01 mm^2
STANDARD_DEVIATION 5.74 • n=5 Participants
|
8.72 mm^2
STANDARD_DEVIATION 6.14 • n=7 Participants
|
8.17 mm^2
STANDARD_DEVIATION 5.51 • n=5 Participants
|
8.22 mm^2
STANDARD_DEVIATION 5.87 • n=4 Participants
|
8.28 mm^2
STANDARD_DEVIATION 5.82 • n=21 Participants
|
|
Best Corrected Visual Acuity (BCVA), assessed by ETDRS chart
|
53.8 Letters correctly read
STANDARD_DEVIATION 13.5 • n=5 Participants
|
52.8 Letters correctly read
STANDARD_DEVIATION 13.9 • n=7 Participants
|
51.6 Letters correctly read
STANDARD_DEVIATION 14.2 • n=5 Participants
|
51.6 Letters correctly read
STANDARD_DEVIATION 13.9 • n=4 Participants
|
52.4 Letters correctly read
STANDARD_DEVIATION 13.9 • n=21 Participants
|
PRIMARY outcome
Timeframe: At week 52Population: Per-Protocol Set (PPS); imputation technique: LOCF
Maintenance of vision was defined as a loss of \< 15 letters in the ETDRS (Early Treatment Diabetic Retinopathy Study) letter score (defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 25 (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision \* 100); Denominator = Number of participants analyzed.
Outcome measures
| Measure |
Ranibizumab 0.5mg Q4
n=269 Participants
Participants received a dose of 0.5 mg Ranibizumab every 4 weeks for the first year (intravitreal \[IVT\] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
|
Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4
n=274 Participants
Participants received a dose of 2.0 mg Aflibercept Injection every 4 weeks for the first year (intravitreal \[IVT\] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
|
Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4
n=268 Participants
Participants received a dose of 0.5 mg Aflibercept Injection every 4 weeks for the first year (intravitreal \[IVT\] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
|
Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8
n=270 Participants
Participants received a dose of 2.0 mg Aflibercept Injection every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year (IVT injection) and were to receive sham injections at interim monthly visits. During the second year, participants received 2.0 mg aflibercept as frequently as every 4 weeks, but no less frequently than every 12 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Who Maintained Vision at Week 52 - Last Observation Carried Forward (LOCF)
|
94.42 Percentage of participants
|
95.62 Percentage of participants
|
96.27 Percentage of participants
|
95.56 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and at week 52Population: Full-Analysis Set (FAS); imputation technique: LOCF
Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 25 (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning.
Outcome measures
| Measure |
Ranibizumab 0.5mg Q4
n=291 Participants
Participants received a dose of 0.5 mg Ranibizumab every 4 weeks for the first year (intravitreal \[IVT\] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
|
Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4
n=309 Participants
Participants received a dose of 2.0 mg Aflibercept Injection every 4 weeks for the first year (intravitreal \[IVT\] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
|
Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4
n=296 Participants
Participants received a dose of 0.5 mg Aflibercept Injection every 4 weeks for the first year (intravitreal \[IVT\] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
|
Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8
n=306 Participants
Participants received a dose of 2.0 mg Aflibercept Injection every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year (IVT injection) and were to receive sham injections at interim monthly visits. During the second year, participants received 2.0 mg aflibercept as frequently as every 4 weeks, but no less frequently than every 12 weeks.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by ETDRS Letter Score at Week 52 - LOCF
|
9.4 Letters correctly read
Standard Deviation 13.5
|
7.6 Letters correctly read
Standard Deviation 12.6
|
9.7 Letters correctly read
Standard Deviation 14.1
|
8.9 Letters correctly read
Standard Deviation 14.4
|
SECONDARY outcome
Timeframe: At week 52Population: Full-Analysis Set; imputation technique: LOCF
Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 25 (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision \* 100); Denominator = Number of participants analyzed.
Outcome measures
| Measure |
Ranibizumab 0.5mg Q4
n=291 Participants
Participants received a dose of 0.5 mg Ranibizumab every 4 weeks for the first year (intravitreal \[IVT\] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
|
Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4
n=309 Participants
Participants received a dose of 2.0 mg Aflibercept Injection every 4 weeks for the first year (intravitreal \[IVT\] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
|
Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4
n=296 Participants
Participants received a dose of 0.5 mg Aflibercept Injection every 4 weeks for the first year (intravitreal \[IVT\] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
|
Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8
n=306 Participants
Participants received a dose of 2.0 mg Aflibercept Injection every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year (IVT injection) and were to receive sham injections at interim monthly visits. During the second year, participants received 2.0 mg aflibercept as frequently as every 4 weeks, but no less frequently than every 12 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Who Gained at Least 15 Letters of Vision in the ETDRS Letter Score in the Study Eye at Week 52 - LOCF
|
34.02 Percentage of participants
|
29.45 Percentage of participants
|
34.80 Percentage of participants
|
31.37 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and at week 52Population: Full-Analysis Set with assessment for this outcome measure; imputation technique: LOCF
The possible range of the NEI VFQ-25 total score is between 0 (worst possible) and 100 (best possible).
Outcome measures
| Measure |
Ranibizumab 0.5mg Q4
n=287 Participants
Participants received a dose of 0.5 mg Ranibizumab every 4 weeks for the first year (intravitreal \[IVT\] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
|
Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4
n=304 Participants
Participants received a dose of 2.0 mg Aflibercept Injection every 4 weeks for the first year (intravitreal \[IVT\] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
|
Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4
n=290 Participants
Participants received a dose of 0.5 mg Aflibercept Injection every 4 weeks for the first year (intravitreal \[IVT\] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
|
Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8
n=299 Participants
Participants received a dose of 2.0 mg Aflibercept Injection every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year (IVT injection) and were to receive sham injections at interim monthly visits. During the second year, participants received 2.0 mg aflibercept as frequently as every 4 weeks, but no less frequently than every 12 weeks.
|
|---|---|---|---|---|
|
Mean Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Total Score at Week 52 - LOCF
|
6.3 Scores on a scale
Standard Deviation 14.8
|
4.5 Scores on a scale
Standard Deviation 15.0
|
5.1 Scores on a scale
Standard Deviation 13.7
|
4.9 Scores on a scale
Standard Deviation 14.7
|
SECONDARY outcome
Timeframe: Baseline and at week 52Population: Full-Analysis Set with assessment for this outcome measure; imputation technique: LOCF
CNV area values measured in square millimeters; lower values represent better outcomes.
Outcome measures
| Measure |
Ranibizumab 0.5mg Q4
n=278 Participants
Participants received a dose of 0.5 mg Ranibizumab every 4 weeks for the first year (intravitreal \[IVT\] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
|
Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4
n=294 Participants
Participants received a dose of 2.0 mg Aflibercept Injection every 4 weeks for the first year (intravitreal \[IVT\] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
|
Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4
n=287 Participants
Participants received a dose of 0.5 mg Aflibercept Injection every 4 weeks for the first year (intravitreal \[IVT\] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
|
Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8
n=289 Participants
Participants received a dose of 2.0 mg Aflibercept Injection every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year (IVT injection) and were to receive sham injections at interim monthly visits. During the second year, participants received 2.0 mg aflibercept as frequently as every 4 weeks, but no less frequently than every 12 weeks.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Choroidal Neovascularization (CNV) Area at Week 52 - LOCF
|
-4.16 mm^2
Standard Deviation 5.90
|
-5.95 mm^2
Standard Deviation 6.12
|
-4.24 mm^2
Standard Deviation 6.13
|
-5.16 mm^2
Standard Deviation 5.87
|
Adverse Events
Ranibizumab 0.5mg Q4
Serious events: 65 serious events
Other events: 254 other events
Deaths: 0 deaths
Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4
Serious events: 81 serious events
Other events: 259 other events
Deaths: 0 deaths
Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4
Serious events: 72 serious events
Other events: 251 other events
Deaths: 0 deaths
Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8
Serious events: 81 serious events
Other events: 260 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ranibizumab 0.5mg Q4
n=291 participants at risk
Participants received a dose of 0.5 mg Ranibizumab every 4 weeks for the first year (intravitreal \[IVT\] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
|
Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4
n=309 participants at risk
Participants received a dose of 2.0 mg Aflibercept Injection every 4 weeks for the first year (intravitreal \[IVT\] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
|
Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4
n=297 participants at risk
Participants received a dose of 0.5 mg Aflibercept Injection every 4 weeks for the first year (intravitreal \[IVT\] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
|
Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8
n=307 participants at risk
Participants received a dose of 2.0 mg Aflibercept Injection every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year (IVT injection) and were to receive sham injections at interim monthly visits. During the second year, participants received 2.0 mg aflibercept as frequently as every 4 weeks, but no less frequently than every 12 weeks.
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.34%
1/291
|
0.00%
0/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/291
|
0.00%
0/309
|
0.34%
1/297
|
0.33%
1/307
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/291
|
0.00%
0/309
|
0.34%
1/297
|
0.00%
0/307
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/291
|
0.00%
0/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.34%
1/291
|
0.00%
0/309
|
0.67%
2/297
|
0.00%
0/307
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign salivary gland neoplasm
|
0.00%
0/291
|
0.32%
1/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/291
|
0.00%
0/309
|
0.34%
1/297
|
0.00%
0/307
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
|
0.00%
0/291
|
0.00%
0/309
|
0.34%
1/297
|
0.00%
0/307
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer stage 0, with cancer in situ
|
0.00%
0/291
|
0.00%
0/309
|
0.34%
1/297
|
0.00%
0/307
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.00%
0/291
|
0.00%
0/309
|
0.34%
1/297
|
0.00%
0/307
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.34%
1/291
|
0.00%
0/309
|
1.0%
3/297
|
0.33%
1/307
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/291
|
0.00%
0/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/291
|
0.65%
2/309
|
0.34%
1/297
|
0.00%
0/307
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/291
|
0.00%
0/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Cardiac disorders
Acute myocardial infarction
|
0.34%
1/291
|
0.00%
0/309
|
0.00%
0/297
|
0.65%
2/307
|
|
Cardiac disorders
Angina pectoris
|
0.34%
1/291
|
0.32%
1/309
|
0.34%
1/297
|
0.00%
0/307
|
|
Cardiac disorders
Angina unstable
|
0.34%
1/291
|
0.00%
0/309
|
0.34%
1/297
|
0.00%
0/307
|
|
Cardiac disorders
Aortic valve stenosis
|
0.34%
1/291
|
0.32%
1/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/291
|
0.00%
0/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/291
|
0.00%
0/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Cardiac disorders
Atrial fibrillation
|
0.69%
2/291
|
0.65%
2/309
|
0.67%
2/297
|
0.98%
3/307
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/291
|
0.65%
2/309
|
0.34%
1/297
|
0.33%
1/307
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/291
|
0.00%
0/309
|
0.34%
1/297
|
0.00%
0/307
|
|
Cardiac disorders
Bradycardia
|
0.34%
1/291
|
0.00%
0/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/291
|
0.00%
0/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Cardiac disorders
Cardiac failure
|
0.34%
1/291
|
0.00%
0/309
|
0.34%
1/297
|
0.33%
1/307
|
|
Cardiac disorders
Cardiac failure congestive
|
0.34%
1/291
|
0.32%
1/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.34%
1/291
|
0.00%
0/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Cardiac disorders
Cardiogenic shock
|
0.34%
1/291
|
0.00%
0/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/291
|
0.32%
1/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Cardiac disorders
Coronary artery thrombosis
|
0.34%
1/291
|
0.00%
0/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Cardiac disorders
Mitral valve incompetence
|
0.34%
1/291
|
0.00%
0/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Cardiac disorders
Myocardial infarction
|
1.4%
4/291
|
0.97%
3/309
|
1.0%
3/297
|
1.3%
4/307
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/291
|
0.00%
0/309
|
0.00%
0/297
|
0.65%
2/307
|
|
Cardiac disorders
Palpitations
|
0.00%
0/291
|
0.32%
1/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/291
|
0.32%
1/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/291
|
0.00%
0/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/291
|
0.32%
1/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/291
|
0.00%
0/309
|
0.34%
1/297
|
0.00%
0/307
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/291
|
0.32%
1/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/291
|
0.00%
0/309
|
0.34%
1/297
|
0.00%
0/307
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/291
|
0.32%
1/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Cardiac disorders
Acute coronary syndrome
|
0.34%
1/291
|
0.65%
2/309
|
0.67%
2/297
|
0.65%
2/307
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/291
|
0.00%
0/309
|
0.34%
1/297
|
0.00%
0/307
|
|
Cardiac disorders
Mitral valve disease
|
0.34%
1/291
|
0.00%
0/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Cardiac disorders
Cardiovascular insufficiency
|
0.00%
0/291
|
0.00%
0/309
|
0.00%
0/297
|
0.65%
2/307
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/291
|
0.00%
0/309
|
0.34%
1/297
|
0.00%
0/307
|
|
Ear and labyrinth disorders
Tympanic membrane disorder
|
0.34%
1/291
|
0.00%
0/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Eye disorders
Blindness
|
0.00%
0/291
|
0.00%
0/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Eye disorders
Cataract
|
1.7%
5/291
|
1.3%
4/309
|
1.3%
4/297
|
1.3%
4/307
|
|
Eye disorders
Cataract cortical
|
0.34%
1/291
|
0.00%
0/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Eye disorders
Cataract nuclear
|
0.00%
0/291
|
0.32%
1/309
|
0.34%
1/297
|
0.00%
0/307
|
|
Eye disorders
Cataract subcapsular
|
0.00%
0/291
|
0.32%
1/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Eye disorders
Choroidal detachment
|
0.00%
0/291
|
0.00%
0/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Eye disorders
Hyphaema
|
0.34%
1/291
|
0.00%
0/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Eye disorders
Iridocyclitis
|
0.00%
0/291
|
0.00%
0/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Eye disorders
Macular cyst
|
0.00%
0/291
|
0.00%
0/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Eye disorders
Macular degeneration
|
0.00%
0/291
|
0.32%
1/309
|
0.00%
0/297
|
0.98%
3/307
|
|
Eye disorders
Maculopathy
|
0.00%
0/291
|
0.00%
0/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Eye disorders
Posterior capsule opacification
|
0.69%
2/291
|
0.00%
0/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Eye disorders
Retinal degeneration
|
0.34%
1/291
|
0.00%
0/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Eye disorders
Retinal detachment
|
1.0%
3/291
|
0.00%
0/309
|
0.34%
1/297
|
0.00%
0/307
|
|
Eye disorders
Retinal haemorrhage
|
1.4%
4/291
|
0.97%
3/309
|
1.3%
4/297
|
0.65%
2/307
|
|
Eye disorders
Retinal pigment epitheliopathy
|
0.00%
0/291
|
0.32%
1/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Eye disorders
Retinal vein occlusion
|
0.00%
0/291
|
0.32%
1/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Eye disorders
Visual acuity reduced
|
1.0%
3/291
|
1.6%
5/309
|
0.34%
1/297
|
2.3%
7/307
|
|
Eye disorders
Vitreous detachment
|
0.00%
0/291
|
0.00%
0/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Eye disorders
Vitreous haemorrhage
|
0.34%
1/291
|
0.32%
1/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Eye disorders
Macular hole
|
0.00%
0/291
|
0.00%
0/309
|
0.34%
1/297
|
0.00%
0/307
|
|
Eye disorders
Ocular retrobulbar haemorrhage
|
0.00%
0/291
|
0.00%
0/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Eye disorders
Choroidal neovascularisation
|
0.34%
1/291
|
0.32%
1/309
|
0.00%
0/297
|
0.65%
2/307
|
|
Eye disorders
Retinal pigment epithelial tear
|
0.34%
1/291
|
0.00%
0/309
|
0.34%
1/297
|
0.65%
2/307
|
|
Eye disorders
Macular scar
|
0.00%
0/291
|
0.32%
1/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Eye disorders
Age-related macular degeneration
|
0.00%
0/291
|
0.97%
3/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Gastrointestinal disorders
Abdominal mass
|
0.00%
0/291
|
0.00%
0/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/291
|
0.32%
1/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/291
|
0.00%
0/309
|
0.34%
1/297
|
0.00%
0/307
|
|
Gastrointestinal disorders
Abnormal faeces
|
0.00%
0/291
|
0.00%
0/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/291
|
0.00%
0/309
|
0.34%
1/297
|
0.00%
0/307
|
|
Gastrointestinal disorders
Colitis
|
0.34%
1/291
|
0.32%
1/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Gastrointestinal disorders
Colonic polyp
|
0.69%
2/291
|
0.00%
0/309
|
0.34%
1/297
|
0.33%
1/307
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/291
|
0.00%
0/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/291
|
0.32%
1/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/291
|
0.00%
0/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Gastrointestinal disorders
Femoral hernia
|
0.00%
0/291
|
0.32%
1/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Gastrointestinal disorders
Femoral hernia, obstructive
|
0.34%
1/291
|
0.00%
0/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/291
|
0.00%
0/309
|
0.34%
1/297
|
0.00%
0/307
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/291
|
0.32%
1/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/291
|
0.00%
0/309
|
0.34%
1/297
|
0.33%
1/307
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/291
|
0.32%
1/309
|
0.34%
1/297
|
0.33%
1/307
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/291
|
0.00%
0/309
|
0.34%
1/297
|
0.00%
0/307
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/291
|
0.00%
0/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Gastrointestinal disorders
Nausea
|
0.34%
1/291
|
0.00%
0/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/291
|
0.00%
0/309
|
0.34%
1/297
|
0.00%
0/307
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/291
|
0.00%
0/309
|
0.34%
1/297
|
0.33%
1/307
|
|
Gastrointestinal disorders
Rectal polyp
|
0.00%
0/291
|
0.00%
0/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.00%
0/291
|
0.00%
0/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/291
|
0.00%
0/309
|
0.34%
1/297
|
0.00%
0/307
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/291
|
0.32%
1/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.00%
0/291
|
0.00%
0/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Gastrointestinal disorders
Bowel movement irregularity
|
0.00%
0/291
|
0.00%
0/309
|
0.00%
0/297
|
0.33%
1/307
|
|
General disorders
Asthenia
|
0.00%
0/291
|
0.00%
0/309
|
0.00%
0/297
|
0.33%
1/307
|
|
General disorders
Chest pain
|
1.0%
3/291
|
0.32%
1/309
|
0.34%
1/297
|
0.33%
1/307
|
|
General disorders
Chills
|
0.00%
0/291
|
0.00%
0/309
|
0.00%
0/297
|
0.33%
1/307
|
|
General disorders
Death
|
0.00%
0/291
|
0.00%
0/309
|
0.34%
1/297
|
0.00%
0/307
|
|
General disorders
Hernia
|
0.00%
0/291
|
0.00%
0/309
|
0.34%
1/297
|
0.00%
0/307
|
|
General disorders
Malaise
|
0.34%
1/291
|
0.00%
0/309
|
0.00%
0/297
|
0.00%
0/307
|
|
General disorders
Multi-organ failure
|
0.34%
1/291
|
0.00%
0/309
|
0.00%
0/297
|
0.00%
0/307
|
|
General disorders
Oedema peripheral
|
0.34%
1/291
|
0.00%
0/309
|
0.00%
0/297
|
0.33%
1/307
|
|
General disorders
Pyrexia
|
0.00%
0/291
|
0.65%
2/309
|
0.00%
0/297
|
0.33%
1/307
|
|
General disorders
Disease progression
|
0.00%
0/291
|
0.32%
1/309
|
0.00%
0/297
|
0.00%
0/307
|
|
General disorders
Device malfunction
|
0.00%
0/291
|
0.32%
1/309
|
0.00%
0/297
|
0.00%
0/307
|
|
General disorders
Device dislocation
|
0.34%
1/291
|
0.32%
1/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/291
|
0.00%
0/309
|
0.34%
1/297
|
0.00%
0/307
|
|
Hepatobiliary disorders
Cholecystitis
|
0.34%
1/291
|
0.65%
2/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/291
|
0.32%
1/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/291
|
0.65%
2/309
|
0.67%
2/297
|
0.00%
0/307
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/291
|
0.00%
0/309
|
0.34%
1/297
|
0.00%
0/307
|
|
Infections and infestations
Appendicitis
|
0.34%
1/291
|
0.00%
0/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Infections and infestations
Bronchitis
|
0.34%
1/291
|
0.32%
1/309
|
0.34%
1/297
|
0.33%
1/307
|
|
Infections and infestations
Diverticulitis
|
0.34%
1/291
|
0.00%
0/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Infections and infestations
Endophthalmitis
|
0.00%
0/291
|
0.32%
1/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/291
|
0.00%
0/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Infections and infestations
Gastroenteritis
|
0.34%
1/291
|
0.00%
0/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.00%
0/291
|
0.00%
0/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Infections and infestations
Herpes zoster
|
0.34%
1/291
|
0.00%
0/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Infections and infestations
Herpes zoster ophthalmic
|
0.00%
0/291
|
0.00%
0/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Infections and infestations
Liver abscess
|
0.00%
0/291
|
0.32%
1/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Infections and infestations
Peridiverticular abscess
|
0.34%
1/291
|
0.00%
0/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Infections and infestations
Pneumonia
|
0.34%
1/291
|
1.3%
4/309
|
0.67%
2/297
|
2.0%
6/307
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/291
|
0.32%
1/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/291
|
0.00%
0/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/291
|
0.00%
0/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Infections and infestations
Septic shock
|
0.00%
0/291
|
0.00%
0/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Infections and infestations
Urinary tract infection
|
0.69%
2/291
|
0.65%
2/309
|
0.34%
1/297
|
0.00%
0/307
|
|
Infections and infestations
Urosepsis
|
0.00%
0/291
|
0.00%
0/309
|
0.34%
1/297
|
0.00%
0/307
|
|
Infections and infestations
Dysentery
|
0.34%
1/291
|
0.00%
0/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Infections and infestations
Respiratory tract infection
|
0.34%
1/291
|
0.00%
0/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.34%
1/291
|
0.00%
0/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Injury, poisoning and procedural complications
Accident
|
0.00%
0/291
|
0.32%
1/309
|
0.34%
1/297
|
0.00%
0/307
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/291
|
0.32%
1/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.00%
0/291
|
0.00%
0/309
|
0.34%
1/297
|
0.00%
0/307
|
|
Injury, poisoning and procedural complications
Cerebral haemorrhage traumatic
|
0.00%
0/291
|
0.00%
0/309
|
0.34%
1/297
|
0.00%
0/307
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/291
|
0.00%
0/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/291
|
0.00%
0/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Injury, poisoning and procedural complications
Fall
|
0.69%
2/291
|
0.32%
1/309
|
0.34%
1/297
|
0.98%
3/307
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/291
|
0.00%
0/309
|
0.34%
1/297
|
0.00%
0/307
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/291
|
0.00%
0/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/291
|
0.32%
1/309
|
0.34%
1/297
|
0.00%
0/307
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.69%
2/291
|
0.32%
1/309
|
0.34%
1/297
|
0.00%
0/307
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/291
|
0.00%
0/309
|
0.34%
1/297
|
0.00%
0/307
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.34%
1/291
|
0.00%
0/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.34%
1/291
|
0.00%
0/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/291
|
0.00%
0/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/291
|
0.32%
1/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/291
|
0.32%
1/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/291
|
0.32%
1/309
|
0.34%
1/297
|
0.33%
1/307
|
|
Injury, poisoning and procedural complications
Skull fractured base
|
0.00%
0/291
|
0.32%
1/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/291
|
0.32%
1/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/291
|
0.00%
0/309
|
0.34%
1/297
|
0.00%
0/307
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/291
|
0.00%
0/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.34%
1/291
|
0.00%
0/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.34%
1/291
|
0.00%
0/309
|
0.00%
0/297
|
0.65%
2/307
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/291
|
0.00%
0/309
|
0.34%
1/297
|
0.00%
0/307
|
|
Injury, poisoning and procedural complications
Graft thrombosis
|
0.00%
0/291
|
0.00%
0/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
0.00%
0/291
|
0.00%
0/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.00%
0/291
|
0.00%
0/309
|
0.00%
0/297
|
0.65%
2/307
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/291
|
0.00%
0/309
|
0.34%
1/297
|
0.00%
0/307
|
|
Injury, poisoning and procedural complications
Traumatic brain injury
|
0.00%
0/291
|
0.32%
1/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.34%
1/291
|
0.00%
0/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.00%
0/291
|
0.00%
0/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.69%
2/291
|
0.32%
1/309
|
1.0%
3/297
|
0.00%
0/307
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/291
|
0.00%
0/309
|
0.67%
2/297
|
0.00%
0/307
|
|
Injury, poisoning and procedural complications
Spinal column injury
|
0.00%
0/291
|
0.32%
1/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Investigations
Blood osmolarity decreased
|
0.00%
0/291
|
0.32%
1/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/291
|
0.32%
1/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Investigations
Haematocrit decreased
|
0.00%
0/291
|
0.32%
1/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/291
|
0.32%
1/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Investigations
Intraocular pressure increased
|
0.00%
0/291
|
0.00%
0/309
|
0.34%
1/297
|
0.65%
2/307
|
|
Investigations
Mean cell haemoglobin decreased
|
0.00%
0/291
|
0.32%
1/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Investigations
Mean cell volume decreased
|
0.00%
0/291
|
0.32%
1/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Investigations
Red blood cell count decreased
|
0.00%
0/291
|
0.32%
1/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Investigations
Investigation
|
0.00%
0/291
|
0.00%
0/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Metabolism and nutrition disorders
Dehydration
|
0.69%
2/291
|
0.32%
1/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.34%
1/291
|
0.00%
0/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/291
|
0.32%
1/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.34%
1/291
|
0.00%
0/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/291
|
0.00%
0/309
|
0.34%
1/297
|
0.00%
0/307
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/291
|
0.00%
0/309
|
0.67%
2/297
|
0.00%
0/307
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/291
|
0.32%
1/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/291
|
0.00%
0/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.34%
1/291
|
0.32%
1/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's contracture
|
0.34%
1/291
|
0.00%
0/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/291
|
0.32%
1/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/291
|
0.32%
1/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/291
|
0.00%
0/309
|
1.0%
3/297
|
0.33%
1/307
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/291
|
0.32%
1/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/291
|
0.00%
0/309
|
0.34%
1/297
|
0.00%
0/307
|
|
Musculoskeletal and connective tissue disorders
Sjogren's syndrome
|
0.00%
0/291
|
0.00%
0/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/291
|
0.00%
0/309
|
0.34%
1/297
|
0.00%
0/307
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour
|
0.00%
0/291
|
0.32%
1/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/291
|
0.32%
1/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer recurrent
|
0.34%
1/291
|
0.00%
0/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/291
|
0.00%
0/309
|
0.34%
1/297
|
0.33%
1/307
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma multiforme
|
0.00%
0/291
|
0.00%
0/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified stage IV
|
0.00%
0/291
|
0.00%
0/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.34%
1/291
|
0.00%
0/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/291
|
0.00%
0/309
|
0.34%
1/297
|
0.00%
0/307
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/291
|
0.00%
0/309
|
0.34%
1/297
|
0.00%
0/307
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to ovary
|
0.00%
0/291
|
0.00%
0/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/291
|
0.00%
0/309
|
0.34%
1/297
|
0.00%
0/307
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.34%
1/291
|
0.00%
0/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.00%
0/291
|
0.32%
1/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/291
|
0.00%
0/309
|
0.34%
1/297
|
0.00%
0/307
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.00%
0/291
|
0.00%
0/309
|
0.34%
1/297
|
0.00%
0/307
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/291
|
0.00%
0/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/291
|
0.32%
1/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.00%
0/291
|
0.00%
0/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.00%
0/291
|
0.32%
1/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/291
|
0.00%
0/309
|
0.67%
2/297
|
0.33%
1/307
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/291
|
0.00%
0/309
|
0.34%
1/297
|
0.00%
0/307
|
|
Nervous system disorders
Cerebrovascular accident
|
0.69%
2/291
|
0.65%
2/309
|
0.34%
1/297
|
0.65%
2/307
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.00%
0/291
|
0.00%
0/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/291
|
0.32%
1/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Nervous system disorders
Headache
|
0.00%
0/291
|
0.32%
1/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Nervous system disorders
Hypertensive encephalopathy
|
0.00%
0/291
|
0.00%
0/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Nervous system disorders
Normal pressure hydrocephalus
|
0.00%
0/291
|
0.32%
1/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Nervous system disorders
Petit mal epilepsy
|
0.00%
0/291
|
0.00%
0/309
|
0.34%
1/297
|
0.00%
0/307
|
|
Nervous system disorders
Presyncope
|
0.34%
1/291
|
0.00%
0/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Nervous system disorders
Sciatica
|
0.00%
0/291
|
0.00%
0/309
|
0.34%
1/297
|
0.00%
0/307
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.34%
1/291
|
0.32%
1/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Nervous system disorders
Syncope
|
0.34%
1/291
|
0.32%
1/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Nervous system disorders
Transient ischaemic attack
|
0.34%
1/291
|
0.65%
2/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/291
|
0.32%
1/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.00%
0/291
|
0.32%
1/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/291
|
0.32%
1/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/291
|
0.32%
1/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/291
|
0.00%
0/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Nervous system disorders
Nerve root compression
|
0.34%
1/291
|
0.00%
0/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/291
|
0.00%
0/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Psychiatric disorders
Depression
|
0.00%
0/291
|
0.00%
0/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/291
|
0.00%
0/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/291
|
0.97%
3/309
|
0.00%
0/297
|
0.65%
2/307
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/291
|
0.00%
0/309
|
0.34%
1/297
|
0.00%
0/307
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/291
|
0.32%
1/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/291
|
0.00%
0/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/291
|
0.32%
1/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/291
|
0.00%
0/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/291
|
0.00%
0/309
|
0.34%
1/297
|
0.00%
0/307
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.00%
0/291
|
0.32%
1/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.00%
0/291
|
0.00%
0/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.69%
2/291
|
0.00%
0/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/291
|
0.32%
1/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/291
|
0.32%
1/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/291
|
0.32%
1/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.34%
1/291
|
0.32%
1/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.34%
1/291
|
0.00%
0/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/291
|
0.00%
0/309
|
0.34%
1/297
|
0.00%
0/307
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/291
|
0.32%
1/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.34%
1/291
|
0.00%
0/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/291
|
0.32%
1/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/291
|
0.00%
0/309
|
0.34%
1/297
|
0.00%
0/307
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/291
|
0.00%
0/309
|
0.34%
1/297
|
0.00%
0/307
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/291
|
0.00%
0/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/291
|
0.00%
0/309
|
0.34%
1/297
|
0.00%
0/307
|
|
Skin and subcutaneous tissue disorders
Pemphigus
|
0.00%
0/291
|
0.00%
0/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/291
|
0.65%
2/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.34%
1/291
|
0.00%
0/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.34%
1/291
|
0.00%
0/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.34%
1/291
|
0.00%
0/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Surgical and medical procedures
Blepharoplasty
|
0.00%
0/291
|
0.32%
1/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Surgical and medical procedures
Strangulated hernia repair
|
0.00%
0/291
|
0.00%
0/309
|
0.34%
1/297
|
0.00%
0/307
|
|
Surgical and medical procedures
Surgery
|
0.00%
0/291
|
0.32%
1/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Surgical and medical procedures
Hip surgery
|
0.00%
0/291
|
0.00%
0/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Surgical and medical procedures
Haematoma evacuation
|
0.34%
1/291
|
0.00%
0/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Surgical and medical procedures
Vaginal operation
|
0.34%
1/291
|
0.00%
0/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/291
|
0.32%
1/309
|
0.34%
1/297
|
0.33%
1/307
|
|
Vascular disorders
Haematoma
|
0.34%
1/291
|
0.00%
0/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Vascular disorders
Hypertension
|
0.00%
0/291
|
0.00%
0/309
|
0.34%
1/297
|
0.33%
1/307
|
|
Vascular disorders
Hypertensive crisis
|
0.34%
1/291
|
0.32%
1/309
|
0.00%
0/297
|
0.65%
2/307
|
|
Vascular disorders
Varicose vein
|
0.34%
1/291
|
0.00%
0/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/291
|
0.00%
0/309
|
0.34%
1/297
|
0.00%
0/307
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.00%
0/291
|
0.00%
0/309
|
0.00%
0/297
|
0.33%
1/307
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/291
|
0.32%
1/309
|
0.00%
0/297
|
0.00%
0/307
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.34%
1/291
|
0.00%
0/309
|
0.00%
0/297
|
0.00%
0/307
|
Other adverse events
| Measure |
Ranibizumab 0.5mg Q4
n=291 participants at risk
Participants received a dose of 0.5 mg Ranibizumab every 4 weeks for the first year (intravitreal \[IVT\] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
|
Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4
n=309 participants at risk
Participants received a dose of 2.0 mg Aflibercept Injection every 4 weeks for the first year (intravitreal \[IVT\] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
|
Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4
n=297 participants at risk
Participants received a dose of 0.5 mg Aflibercept Injection every 4 weeks for the first year (intravitreal \[IVT\] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
|
Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8
n=307 participants at risk
Participants received a dose of 2.0 mg Aflibercept Injection every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year (IVT injection) and were to receive sham injections at interim monthly visits. During the second year, participants received 2.0 mg aflibercept as frequently as every 4 weeks, but no less frequently than every 12 weeks.
|
|---|---|---|---|---|
|
Cardiac disorders
Atrioventricular block first degree
|
5.5%
16/291
|
8.1%
25/309
|
7.7%
23/297
|
7.2%
22/307
|
|
Eye disorders
Cataract
|
10.0%
29/291
|
11.7%
36/309
|
11.4%
34/297
|
10.4%
32/307
|
|
Eye disorders
Conjunctival haemorrhage
|
11.7%
34/291
|
10.7%
33/309
|
15.5%
46/297
|
11.4%
35/307
|
|
Eye disorders
Conjunctivitis
|
6.5%
19/291
|
4.5%
14/309
|
2.7%
8/297
|
6.8%
21/307
|
|
Eye disorders
Dry eye
|
4.8%
14/291
|
3.9%
12/309
|
5.1%
15/297
|
5.2%
16/307
|
|
Eye disorders
Eye pain
|
9.6%
28/291
|
11.7%
36/309
|
8.4%
25/297
|
7.8%
24/307
|
|
Eye disorders
Macular cyst
|
6.2%
18/291
|
2.6%
8/309
|
3.0%
9/297
|
2.9%
9/307
|
|
Eye disorders
Macular degeneration
|
12.7%
37/291
|
11.3%
35/309
|
14.1%
42/297
|
16.6%
51/307
|
|
Eye disorders
Macular oedema
|
5.8%
17/291
|
5.2%
16/309
|
7.7%
23/297
|
7.2%
22/307
|
|
Eye disorders
Maculopathy
|
4.5%
13/291
|
5.2%
16/309
|
6.1%
18/297
|
3.3%
10/307
|
|
Eye disorders
Ocular hyperaemia
|
6.9%
20/291
|
5.8%
18/309
|
5.7%
17/297
|
3.3%
10/307
|
|
Eye disorders
Retinal cyst
|
4.5%
13/291
|
6.5%
20/309
|
5.7%
17/297
|
4.2%
13/307
|
|
Eye disorders
Retinal degeneration
|
11.3%
33/291
|
12.0%
37/309
|
9.1%
27/297
|
7.5%
23/307
|
|
Eye disorders
Retinal haemorrhage
|
28.2%
82/291
|
27.2%
84/309
|
23.6%
70/297
|
26.7%
82/307
|
|
Eye disorders
Retinal oedema
|
11.7%
34/291
|
10.4%
32/309
|
10.4%
31/297
|
13.0%
40/307
|
|
Eye disorders
Retinal pigment epitheliopathy
|
9.6%
28/291
|
7.4%
23/309
|
6.7%
20/297
|
9.1%
28/307
|
|
Eye disorders
Visual acuity reduced
|
15.8%
46/291
|
14.2%
44/309
|
18.5%
55/297
|
19.5%
60/307
|
|
Eye disorders
Vitreous detachment
|
7.6%
22/291
|
9.7%
30/309
|
5.7%
17/297
|
7.8%
24/307
|
|
Eye disorders
Conjunctival hyperaemia
|
6.2%
18/291
|
2.6%
8/309
|
3.7%
11/297
|
1.6%
5/307
|
|
Eye disorders
Detachment of retinal pigment epithelium
|
13.1%
38/291
|
12.0%
37/309
|
11.1%
33/297
|
10.1%
31/307
|
|
Eye disorders
Choroidal neovascularisation
|
9.6%
28/291
|
8.1%
25/309
|
9.4%
28/297
|
7.5%
23/307
|
|
Eye disorders
Age-related macular degeneration
|
8.9%
26/291
|
9.1%
28/309
|
8.8%
26/297
|
12.4%
38/307
|
|
Gastrointestinal disorders
Diarrhoea
|
4.8%
14/291
|
2.9%
9/309
|
5.4%
16/297
|
5.2%
16/307
|
|
General disorders
Pyrexia
|
6.5%
19/291
|
3.9%
12/309
|
6.4%
19/297
|
2.6%
8/307
|
|
Infections and infestations
Bronchitis
|
4.5%
13/291
|
5.5%
17/309
|
6.7%
20/297
|
3.9%
12/307
|
|
Infections and infestations
Influenza
|
4.8%
14/291
|
6.1%
19/309
|
4.0%
12/297
|
7.5%
23/307
|
|
Infections and infestations
Nasopharyngitis
|
13.4%
39/291
|
8.1%
25/309
|
10.8%
32/297
|
8.5%
26/307
|
|
Investigations
Blood glucose increased
|
3.1%
9/291
|
5.5%
17/309
|
4.7%
14/297
|
5.9%
18/307
|
|
Investigations
Intraocular pressure increased
|
12.7%
37/291
|
12.3%
38/309
|
8.1%
24/297
|
9.4%
29/307
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.8%
11/291
|
2.6%
8/309
|
5.1%
15/297
|
2.3%
7/307
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.8%
17/291
|
6.1%
19/309
|
4.0%
12/297
|
5.2%
16/307
|
|
Nervous system disorders
Dizziness
|
5.2%
15/291
|
2.6%
8/309
|
1.3%
4/297
|
1.6%
5/307
|
|
Nervous system disorders
Headache
|
4.8%
14/291
|
3.9%
12/309
|
5.4%
16/297
|
6.5%
20/307
|
|
Vascular disorders
Hypertension
|
14.4%
42/291
|
13.3%
41/309
|
11.1%
33/297
|
11.1%
34/307
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Confidentiality agreement with sponsor, contract with the sponsor via the CRO (Clinical research organization), set up based on local legal requirements, changes addressed+confirmed with local responsible persons; PIs interested in presenting the study on meetings, contacted the sponsor and received slides and approval to do so either by the Clinical Lead or the Medical Affairs department
- Publication restrictions are in place
Restriction type: OTHER