Trial Outcomes & Findings for Treatment for CI-DME in Eyes With Very Good VA Study (NCT NCT01909791)
NCT ID: NCT01909791
Last Updated: 2020-07-31
Results Overview
Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/12) to 0 letters (Snellen equivalent of 20/800).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
702 participants
Primary outcome timeframe
2 years
Results posted on
2020-07-31
Participant Flow
Participant milestones
| Measure |
Initiation With Aflibercept
Intravitreal aflibercept at baseline and every 4 weeks as needed (deferred laser may be added to intravitreal aflibercept if certain criteria are met)
Prompt aflibercept: Intravitreal injection of 2.0mg aflibercept performed on the day of randomization and up to every 4 weeks using defined treatment criteria
Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met
|
Initiation With Laser Photocoagulation
Focal/grid laser followed by intravitreal aflibercept if vision worsens
Prompt Laser: Focal/grid laser performed at baseline and as needed during follow-up
Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria
|
Initiation With Observation
No treatment to start followed by intravitreal aflibercept if vision worsens (deferred laser may be added to intravitreal aflibercept if certain criteria are met)
Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met
Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria
|
|---|---|---|---|
|
Overall Study
STARTED
|
226
|
240
|
236
|
|
Overall Study
COMPLETED
|
205
|
212
|
208
|
|
Overall Study
NOT COMPLETED
|
21
|
28
|
28
|
Reasons for withdrawal
| Measure |
Initiation With Aflibercept
Intravitreal aflibercept at baseline and every 4 weeks as needed (deferred laser may be added to intravitreal aflibercept if certain criteria are met)
Prompt aflibercept: Intravitreal injection of 2.0mg aflibercept performed on the day of randomization and up to every 4 weeks using defined treatment criteria
Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met
|
Initiation With Laser Photocoagulation
Focal/grid laser followed by intravitreal aflibercept if vision worsens
Prompt Laser: Focal/grid laser performed at baseline and as needed during follow-up
Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria
|
Initiation With Observation
No treatment to start followed by intravitreal aflibercept if vision worsens (deferred laser may be added to intravitreal aflibercept if certain criteria are met)
Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met
Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria
|
|---|---|---|---|
|
Overall Study
Death
|
9
|
8
|
4
|
|
Overall Study
Withdrawal by Subject
|
5
|
9
|
13
|
|
Overall Study
Lost to Follow-up
|
5
|
11
|
10
|
|
Overall Study
Missed Visit
|
2
|
0
|
1
|
Baseline Characteristics
Hemoglobin A1c was missing for 9,8, and 10 eyes in the initiation with aflibercept, initiation with laser photocoagulation, and initiation with observation groups, respectively.
Baseline characteristics by cohort
| Measure |
Initiation With Aflibercept
n=226 Eyes
Intravitreal aflibercept at baseline and every 4 weeks as needed (deferred laser may be added to intravitreal aflibercept if certain criteria are met)
Prompt aflibercept: Intravitreal injection of 2.0mg aflibercept performed on the day of randomization and up to every 4 weeks using defined treatment criteria
Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met
|
Initiation With Laser Photocoagulation
n=240 Eyes
Focal/grid laser followed by intravitreal aflibercept if vision worsens
Prompt Laser: Focal/grid laser performed at baseline and as needed during follow-up
Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria
|
Initiation With Observation
n=236 Eyes
No treatment to start followed by intravitreal aflibercept if vision worsens (deferred laser may be added to intravitreal aflibercept if certain criteria are met)
Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met
Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria
|
Total
n=702 Eyes
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
59 years
n=226 Participants
|
60 years
n=240 Participants
|
60 years
n=236 Participants
|
60 years
n=702 Participants
|
|
Sex: Female, Male
Female
|
95 Participants
n=226 Participants
|
82 Participants
n=240 Participants
|
87 Participants
n=236 Participants
|
264 Participants
n=702 Participants
|
|
Sex: Female, Male
Male
|
131 Participants
n=226 Participants
|
158 Participants
n=240 Participants
|
149 Participants
n=236 Participants
|
438 Participants
n=702 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Non-Hispanic White
|
145 Participants
n=226 Participants
|
160 Participants
n=240 Participants
|
161 Participants
n=236 Participants
|
466 Participants
n=702 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Non-Hispanic Black/African American
|
37 Participants
n=226 Participants
|
36 Participants
n=240 Participants
|
41 Participants
n=236 Participants
|
114 Participants
n=702 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Hispanic or Latino
|
31 Participants
n=226 Participants
|
35 Participants
n=240 Participants
|
25 Participants
n=236 Participants
|
91 Participants
n=702 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Asian
|
6 Participants
n=226 Participants
|
1 Participants
n=240 Participants
|
5 Participants
n=236 Participants
|
12 Participants
n=702 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · American Indian or Alaskan Native
|
1 Participants
n=226 Participants
|
1 Participants
n=240 Participants
|
0 Participants
n=236 Participants
|
2 Participants
n=702 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Native Hawaiian or other Pacific Islander
|
0 Participants
n=226 Participants
|
3 Participants
n=240 Participants
|
1 Participants
n=236 Participants
|
4 Participants
n=702 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · More than one race
|
4 Participants
n=226 Participants
|
2 Participants
n=240 Participants
|
1 Participants
n=236 Participants
|
7 Participants
n=702 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Unknown or not reported
|
2 Participants
n=226 Participants
|
2 Participants
n=240 Participants
|
2 Participants
n=236 Participants
|
6 Participants
n=702 Participants
|
|
Region of Enrollment
Canada
|
1 Participants
n=226 Participants
|
2 Participants
n=240 Participants
|
4 Participants
n=236 Participants
|
7 Participants
n=702 Participants
|
|
Region of Enrollment
United States
|
225 Participants
n=226 Participants
|
238 Participants
n=240 Participants
|
232 Participants
n=236 Participants
|
695 Participants
n=702 Participants
|
|
Diabetes type
Type 2
|
211 Participants
n=226 Participants
|
221 Participants
n=240 Participants
|
210 Participants
n=236 Participants
|
642 Participants
n=702 Participants
|
|
Diabetes type
Type 1
|
13 Participants
n=226 Participants
|
18 Participants
n=240 Participants
|
18 Participants
n=236 Participants
|
49 Participants
n=702 Participants
|
|
Diabetes type
Uncertain
|
2 Participants
n=226 Participants
|
1 Participants
n=240 Participants
|
8 Participants
n=236 Participants
|
11 Participants
n=702 Participants
|
|
Duration of diabetes
|
15 years
n=226 Participants
|
15 years
n=240 Participants
|
16 years
n=236 Participants
|
15 years
n=702 Participants
|
|
Insulin used
|
161 Participants
n=226 Participants
|
145 Participants
n=240 Participants
|
160 Participants
n=236 Participants
|
466 Participants
n=702 Participants
|
|
Hemoglobin A1c
|
7.6 Hemoglobin A1c percentage
n=217 Participants • Hemoglobin A1c was missing for 9,8, and 10 eyes in the initiation with aflibercept, initiation with laser photocoagulation, and initiation with observation groups, respectively.
|
7.6 Hemoglobin A1c percentage
n=232 Participants • Hemoglobin A1c was missing for 9,8, and 10 eyes in the initiation with aflibercept, initiation with laser photocoagulation, and initiation with observation groups, respectively.
|
7.6 Hemoglobin A1c percentage
n=226 Participants • Hemoglobin A1c was missing for 9,8, and 10 eyes in the initiation with aflibercept, initiation with laser photocoagulation, and initiation with observation groups, respectively.
|
7.6 Hemoglobin A1c percentage
n=675 Participants • Hemoglobin A1c was missing for 9,8, and 10 eyes in the initiation with aflibercept, initiation with laser photocoagulation, and initiation with observation groups, respectively.
|
|
Arterial blood pressure
|
99 mmHg
n=226 Participants
|
98 mmHg
n=240 Participants
|
98 mmHg
n=236 Participants
|
98 mmHg
n=702 Participants
|
|
Prior myocardial infarction
|
11 Participants
n=226 Participants
|
21 Participants
n=240 Participants
|
19 Participants
n=236 Participants
|
51 Participants
n=702 Participants
|
|
Prior stroke
|
16 Participants
n=226 Participants
|
6 Participants
n=240 Participants
|
9 Participants
n=236 Participants
|
31 Participants
n=702 Participants
|
|
Body mass index
|
32.3 kg/m^2
n=184 Participants • Missing for 42, 33, and 37 participants in the aflibercept, laser and observation groups, respectively.
|
32.1 kg/m^2
n=207 Participants • Missing for 42, 33, and 37 participants in the aflibercept, laser and observation groups, respectively.
|
32.3 kg/m^2
n=199 Participants • Missing for 42, 33, and 37 participants in the aflibercept, laser and observation groups, respectively.
|
32.2 kg/m^2
n=590 Participants • Missing for 42, 33, and 37 participants in the aflibercept, laser and observation groups, respectively.
|
|
Daily cigarette smoking
Never
|
165 Participants
n=226 Participants
|
157 Participants
n=240 Participants
|
141 Participants
n=236 Participants
|
463 Participants
n=702 Participants
|
|
Daily cigarette smoking
Prior
|
46 Participants
n=226 Participants
|
67 Participants
n=240 Participants
|
75 Participants
n=236 Participants
|
188 Participants
n=702 Participants
|
|
Daily cigarette smoking
Current
|
15 Participants
n=226 Participants
|
16 Participants
n=240 Participants
|
20 Participants
n=236 Participants
|
51 Participants
n=702 Participants
|
|
Recent or planned diabetic macular edema treatment in non-study eye
|
86 Eyes
n=226 Eyes
|
90 Eyes
n=240 Eyes
|
92 Eyes
n=236 Eyes
|
268 Eyes
n=702 Eyes
|
|
Prior treatment for diabetic macular edema
|
34 Eyes
n=226 Eyes
|
31 Eyes
n=240 Eyes
|
34 Eyes
n=236 Eyes
|
99 Eyes
n=702 Eyes
|
|
Prior anti-VEGF for diabetic macular edema
|
11 Eyes
n=226 Eyes
|
14 Eyes
n=240 Eyes
|
13 Eyes
n=236 Eyes
|
38 Eyes
n=702 Eyes
|
|
Prior focal/grid laser photocoagulation for diabetic macular edema
|
26 Eyes
n=226 Eyes
|
24 Eyes
n=240 Eyes
|
24 Eyes
n=236 Eyes
|
74 Eyes
n=702 Eyes
|
|
Prior panretinal photocoagulation
|
15 Eyes
n=226 Eyes
|
12 Eyes
n=240 Eyes
|
9 Eyes
n=236 Eyes
|
36 Eyes
n=702 Eyes
|
|
Lens status at clinical examination
Phakic (natural lens)
|
180 Eyes
n=226 Eyes
|
188 Eyes
n=240 Eyes
|
182 Eyes
n=236 Eyes
|
550 Eyes
n=702 Eyes
|
|
Lens status at clinical examination
Prosthetic intraocular lens
|
46 Eyes
n=226 Eyes
|
52 Eyes
n=240 Eyes
|
54 Eyes
n=236 Eyes
|
152 Eyes
n=702 Eyes
|
|
E-ETDRS visual acuity letter score
|
85.2 units on a scale
STANDARD_DEVIATION 3.5 • n=226 Eyes
|
85.2 units on a scale
STANDARD_DEVIATION 3.8 • n=240 Eyes
|
85.2 units on a scale
STANDARD_DEVIATION 3.8 • n=236 Eyes
|
85.2 units on a scale
STANDARD_DEVIATION 3.7 • n=702 Eyes
|
|
Intraocular pressure
|
15 mmHg
n=226 Eyes
|
15 mmHg
n=240 Eyes
|
15 mmHg
n=236 Eyes
|
15 mmHg
n=702 Eyes
|
|
Patient-reported visual complaints presumed to be from diabetic macular edema
|
99 Eyes
n=226 Eyes
|
116 Eyes
n=240 Eyes
|
118 Eyes
n=236 Eyes
|
333 Eyes
n=702 Eyes
|
|
Optical coherence tomography machine used to measure central subfield thickness
Heidelberg Spectralis
|
148 Eyes
n=226 Eyes
|
151 Eyes
n=240 Eyes
|
151 Eyes
n=236 Eyes
|
450 Eyes
n=702 Eyes
|
|
Optical coherence tomography machine used to measure central subfield thickness
Zeiss Cirrus
|
78 Eyes
n=226 Eyes
|
89 Eyes
n=240 Eyes
|
85 Eyes
n=236 Eyes
|
252 Eyes
n=702 Eyes
|
|
Central subfield thickness (time-domain equivalent)
|
306 Microns
STANDARD_DEVIATION 55 • n=226 Eyes
|
314 Microns
STANDARD_DEVIATION 52 • n=240 Eyes
|
314 Microns
STANDARD_DEVIATION 64 • n=236 Eyes
|
311 Microns
STANDARD_DEVIATION 57 • n=702 Eyes
|
|
Macular volume (time-domain equivalent)
|
7.9 mm^3
STANDARD_DEVIATION 1.1 • n=226 Eyes • missing for one participant in the observation group
|
8.0 mm^3
STANDARD_DEVIATION 1.2 • n=240 Eyes • missing for one participant in the observation group
|
8.0 mm^3
STANDARD_DEVIATION 1.1 • n=235 Eyes • missing for one participant in the observation group
|
8.0 mm^3
STANDARD_DEVIATION 1.0 • n=701 Eyes • missing for one participant in the observation group
|
|
Diabetic retinopathy severity level
Diabetic Retinopathy absent or questionable
|
2 Eyes
n=216 Eyes • Missing for 10, 13, and 7 eyes in the aflibercept, laser, and observation groups, respectively.
|
4 Eyes
n=227 Eyes • Missing for 10, 13, and 7 eyes in the aflibercept, laser, and observation groups, respectively.
|
1 Eyes
n=229 Eyes • Missing for 10, 13, and 7 eyes in the aflibercept, laser, and observation groups, respectively.
|
7 Eyes
n=672 Eyes • Missing for 10, 13, and 7 eyes in the aflibercept, laser, and observation groups, respectively.
|
|
Diabetic retinopathy severity level
Microaneurysms only
|
13 Eyes
n=216 Eyes • Missing for 10, 13, and 7 eyes in the aflibercept, laser, and observation groups, respectively.
|
8 Eyes
n=227 Eyes • Missing for 10, 13, and 7 eyes in the aflibercept, laser, and observation groups, respectively.
|
6 Eyes
n=229 Eyes • Missing for 10, 13, and 7 eyes in the aflibercept, laser, and observation groups, respectively.
|
27 Eyes
n=672 Eyes • Missing for 10, 13, and 7 eyes in the aflibercept, laser, and observation groups, respectively.
|
|
Diabetic retinopathy severity level
Mild to moderate NPDR
|
119 Eyes
n=216 Eyes • Missing for 10, 13, and 7 eyes in the aflibercept, laser, and observation groups, respectively.
|
132 Eyes
n=227 Eyes • Missing for 10, 13, and 7 eyes in the aflibercept, laser, and observation groups, respectively.
|
142 Eyes
n=229 Eyes • Missing for 10, 13, and 7 eyes in the aflibercept, laser, and observation groups, respectively.
|
393 Eyes
n=672 Eyes • Missing for 10, 13, and 7 eyes in the aflibercept, laser, and observation groups, respectively.
|
|
Diabetic retinopathy severity level
Moderately severe to severe NPDR
|
58 Eyes
n=216 Eyes • Missing for 10, 13, and 7 eyes in the aflibercept, laser, and observation groups, respectively.
|
64 Eyes
n=227 Eyes • Missing for 10, 13, and 7 eyes in the aflibercept, laser, and observation groups, respectively.
|
62 Eyes
n=229 Eyes • Missing for 10, 13, and 7 eyes in the aflibercept, laser, and observation groups, respectively.
|
184 Eyes
n=672 Eyes • Missing for 10, 13, and 7 eyes in the aflibercept, laser, and observation groups, respectively.
|
|
Diabetic retinopathy severity level
Inactive PDR
|
6 Eyes
n=216 Eyes • Missing for 10, 13, and 7 eyes in the aflibercept, laser, and observation groups, respectively.
|
7 Eyes
n=227 Eyes • Missing for 10, 13, and 7 eyes in the aflibercept, laser, and observation groups, respectively.
|
7 Eyes
n=229 Eyes • Missing for 10, 13, and 7 eyes in the aflibercept, laser, and observation groups, respectively.
|
20 Eyes
n=672 Eyes • Missing for 10, 13, and 7 eyes in the aflibercept, laser, and observation groups, respectively.
|
|
Diabetic retinopathy severity level
Mild to moderate PDR
|
14 Eyes
n=216 Eyes • Missing for 10, 13, and 7 eyes in the aflibercept, laser, and observation groups, respectively.
|
12 Eyes
n=227 Eyes • Missing for 10, 13, and 7 eyes in the aflibercept, laser, and observation groups, respectively.
|
9 Eyes
n=229 Eyes • Missing for 10, 13, and 7 eyes in the aflibercept, laser, and observation groups, respectively.
|
35 Eyes
n=672 Eyes • Missing for 10, 13, and 7 eyes in the aflibercept, laser, and observation groups, respectively.
|
PRIMARY outcome
Timeframe: 2 yearsBest-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/12) to 0 letters (Snellen equivalent of 20/800).
Outcome measures
| Measure |
Initiation With Aflibercept
n=205 Eyes
Intravitreal aflibercept at baseline and every 4 weeks as needed (deferred laser may be added to intravitreal aflibercept if certain criteria are met)
Prompt aflibercept: Intravitreal injection of 2.0mg aflibercept performed on the day of randomization and up to every 4 weeks using defined treatment criteria
Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met
|
Initiation With Laser Photocoagulation
n=212 Eyes
Focal/grid laser followed by intravitreal aflibercept if vision worsens
Prompt Laser: Focal/grid laser performed at baseline and as needed during follow-up
Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria
|
Initiation With Observation
n=208 Eyes
No treatment to start followed by intravitreal aflibercept if vision worsens (deferred laser may be added to intravitreal aflibercept if certain criteria are met)
Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met
Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria
|
|---|---|---|---|
|
Number of Eyes With at Least 5-letter Decrease in E-ETDRS Visual Acuity Letter Score From Baseline
|
33 Eyes
|
36 Eyes
|
39 Eyes
|
SECONDARY outcome
Timeframe: 1 yearBest-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/12) to 0 letters (Snellen equivalent of 20/800).
Outcome measures
| Measure |
Initiation With Aflibercept
n=210 Eyes
Intravitreal aflibercept at baseline and every 4 weeks as needed (deferred laser may be added to intravitreal aflibercept if certain criteria are met)
Prompt aflibercept: Intravitreal injection of 2.0mg aflibercept performed on the day of randomization and up to every 4 weeks using defined treatment criteria
Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met
|
Initiation With Laser Photocoagulation
n=226 Eyes
Focal/grid laser followed by intravitreal aflibercept if vision worsens
Prompt Laser: Focal/grid laser performed at baseline and as needed during follow-up
Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria
|
Initiation With Observation
n=220 Eyes
No treatment to start followed by intravitreal aflibercept if vision worsens (deferred laser may be added to intravitreal aflibercept if certain criteria are met)
Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met
Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria
|
|---|---|---|---|
|
Number of Eyes With at Least 5-letter Increase or at Least 5-, 10-, or 15-letter Decrease in E-ETDRS Visual Acuity Letter Score From Baseline
≥ 5-Letter Increase
|
61 Eyes
|
44 Eyes
|
33 Eyes
|
|
Number of Eyes With at Least 5-letter Increase or at Least 5-, 10-, or 15-letter Decrease in E-ETDRS Visual Acuity Letter Score From Baseline
≥ 5-Letter Decrease
|
19 Eyes
|
36 Eyes
|
25 Eyes
|
|
Number of Eyes With at Least 5-letter Increase or at Least 5-, 10-, or 15-letter Decrease in E-ETDRS Visual Acuity Letter Score From Baseline
≥ 10-Letter Decrease
|
6 Eyes
|
9 Eyes
|
7 Eyes
|
|
Number of Eyes With at Least 5-letter Increase or at Least 5-, 10-, or 15-letter Decrease in E-ETDRS Visual Acuity Letter Score From Baseline
≥ 15-Letter Decrease
|
3 Eyes
|
4 Eyes
|
6 Eyes
|
SECONDARY outcome
Timeframe: 1 yearBest-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/12) to 0 letters (Snellen equivalent of 20/800).
Outcome measures
| Measure |
Initiation With Aflibercept
n=210 Eyes
Intravitreal aflibercept at baseline and every 4 weeks as needed (deferred laser may be added to intravitreal aflibercept if certain criteria are met)
Prompt aflibercept: Intravitreal injection of 2.0mg aflibercept performed on the day of randomization and up to every 4 weeks using defined treatment criteria
Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met
|
Initiation With Laser Photocoagulation
n=226 Eyes
Focal/grid laser followed by intravitreal aflibercept if vision worsens
Prompt Laser: Focal/grid laser performed at baseline and as needed during follow-up
Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria
|
Initiation With Observation
n=220 Eyes
No treatment to start followed by intravitreal aflibercept if vision worsens (deferred laser may be added to intravitreal aflibercept if certain criteria are met)
Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met
Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria
|
|---|---|---|---|
|
Change in E-ETDRS Visual Acuity Letter Score From Baseline
|
2.1 units on a scale
Standard Deviation 5.0
|
0.1 units on a scale
Standard Deviation 5.5
|
0.0 units on a scale
Standard Deviation 5.4
|
SECONDARY outcome
Timeframe: 2 yearPopulation: Best-corrected visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the early treatment diabetic retinopathy study method . Best value on the scale 100, worst 0.
Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/12) to 0 letters (Snellen equivalent of 20/800). The area under the curve (units = letters·years) was divided by 2 years (units = years) to obtain an average change in letter score (units = letters) over the 2-year follow-up.
Outcome measures
| Measure |
Initiation With Aflibercept
n=205 Eyes
Intravitreal aflibercept at baseline and every 4 weeks as needed (deferred laser may be added to intravitreal aflibercept if certain criteria are met)
Prompt aflibercept: Intravitreal injection of 2.0mg aflibercept performed on the day of randomization and up to every 4 weeks using defined treatment criteria
Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met
|
Initiation With Laser Photocoagulation
n=212 Eyes
Focal/grid laser followed by intravitreal aflibercept if vision worsens
Prompt Laser: Focal/grid laser performed at baseline and as needed during follow-up
Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria
|
Initiation With Observation
n=208 Eyes
No treatment to start followed by intravitreal aflibercept if vision worsens (deferred laser may be added to intravitreal aflibercept if certain criteria are met)
Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met
Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria
|
|---|---|---|---|
|
Change in E-ETDRS Visual Acuity Letter Score From Baseline Over 2 Years (Area Under the Curve)
|
1.5 units on a scale
Standard Deviation 4.0
|
0.0 units on a scale
Standard Deviation 3.9
|
-0.4 units on a scale
Standard Deviation 4.2
|
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
| Measure |
Initiation With Aflibercept
n=205 Eyes
Intravitreal aflibercept at baseline and every 4 weeks as needed (deferred laser may be added to intravitreal aflibercept if certain criteria are met)
Prompt aflibercept: Intravitreal injection of 2.0mg aflibercept performed on the day of randomization and up to every 4 weeks using defined treatment criteria
Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met
|
Initiation With Laser Photocoagulation
n=212 Eyes
Focal/grid laser followed by intravitreal aflibercept if vision worsens
Prompt Laser: Focal/grid laser performed at baseline and as needed during follow-up
Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria
|
Initiation With Observation
n=207 Eyes
No treatment to start followed by intravitreal aflibercept if vision worsens (deferred laser may be added to intravitreal aflibercept if certain criteria are met)
Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met
Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria
|
|---|---|---|---|
|
Change in OCT Central Subfield Thickness From Baseline
|
-48 microns
Standard Deviation 65
|
-41 microns
Standard Deviation 75
|
-42 microns
Standard Deviation 75
|
SECONDARY outcome
Timeframe: 1 yearLogarithmic transformation of optical coherence tomography central subfield thickness (CST) is calculated by taking the log base 10 of the ratio of the central subfield thickness divided by 200 and rounding to the nearest hundredth. The change is the change in the log values.
Outcome measures
| Measure |
Initiation With Aflibercept
n=210 Eyes
Intravitreal aflibercept at baseline and every 4 weeks as needed (deferred laser may be added to intravitreal aflibercept if certain criteria are met)
Prompt aflibercept: Intravitreal injection of 2.0mg aflibercept performed on the day of randomization and up to every 4 weeks using defined treatment criteria
Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met
|
Initiation With Laser Photocoagulation
n=223 Eyes
Focal/grid laser followed by intravitreal aflibercept if vision worsens
Prompt Laser: Focal/grid laser performed at baseline and as needed during follow-up
Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria
|
Initiation With Observation
n=220 Eyes
No treatment to start followed by intravitreal aflibercept if vision worsens (deferred laser may be added to intravitreal aflibercept if certain criteria are met)
Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met
Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria
|
|---|---|---|---|
|
Number of Eyes With at Least 1 or 2 Logarithmic-step Central Subfield Thickness Improvement and Worsening
≥ 2 log-step CST decrease (improvement)
|
7 Eyes
|
11 Eyes
|
8 Eyes
|
|
Number of Eyes With at Least 1 or 2 Logarithmic-step Central Subfield Thickness Improvement and Worsening
≥ 1 log-step CST decrease (improvement)
|
56 Eyes
|
45 Eyes
|
39 Eyes
|
|
Number of Eyes With at Least 1 or 2 Logarithmic-step Central Subfield Thickness Improvement and Worsening
≥ 1 log-step CST increase (worsening)
|
1 Eyes
|
12 Eyes
|
14 Eyes
|
|
Number of Eyes With at Least 1 or 2 Logarithmic-step Central Subfield Thickness Improvement and Worsening
≥ 2 log-step CST increase (worsening)
|
0 Eyes
|
3 Eyes
|
3 Eyes
|
SECONDARY outcome
Timeframe: 1 yearCenter-involved diabetic macular edema defined as follows by central subfield thickness according to optical coherence tomography machine and sex: Heidelberg Spectralis ≥ 305 µm in women and ≥ 320 µm in men, and Zeiss Cirrus ≥ 290 µm in women and ≥ 305 µm in men.
Outcome measures
| Measure |
Initiation With Aflibercept
n=210 Eyes
Intravitreal aflibercept at baseline and every 4 weeks as needed (deferred laser may be added to intravitreal aflibercept if certain criteria are met)
Prompt aflibercept: Intravitreal injection of 2.0mg aflibercept performed on the day of randomization and up to every 4 weeks using defined treatment criteria
Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met
|
Initiation With Laser Photocoagulation
n=223 Eyes
Focal/grid laser followed by intravitreal aflibercept if vision worsens
Prompt Laser: Focal/grid laser performed at baseline and as needed during follow-up
Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria
|
Initiation With Observation
n=220 Eyes
No treatment to start followed by intravitreal aflibercept if vision worsens (deferred laser may be added to intravitreal aflibercept if certain criteria are met)
Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met
Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria
|
|---|---|---|---|
|
Number of Eyes With no Center-involved Diabetic Macular Edema and at Least 10% Central Subfield Thickness Decrease
|
93 Eyes
|
58 Eyes
|
67 Eyes
|
SECONDARY outcome
Timeframe: 1 yearOutcome measures
| Measure |
Initiation With Aflibercept
n=210 Eyes
Intravitreal aflibercept at baseline and every 4 weeks as needed (deferred laser may be added to intravitreal aflibercept if certain criteria are met)
Prompt aflibercept: Intravitreal injection of 2.0mg aflibercept performed on the day of randomization and up to every 4 weeks using defined treatment criteria
Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met
|
Initiation With Laser Photocoagulation
n=226 Eyes
Focal/grid laser followed by intravitreal aflibercept if vision worsens
Prompt Laser: Focal/grid laser performed at baseline and as needed during follow-up
Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria
|
Initiation With Observation
n=220 Eyes
No treatment to start followed by intravitreal aflibercept if vision worsens (deferred laser may be added to intravitreal aflibercept if certain criteria are met)
Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met
Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria
|
|---|---|---|---|
|
Cumulative Number of Intraocular Injections of 2.0-mg Aflibercept Received Per Participant
|
6.0 Injections
Standard Deviation 2.5
|
0.7 Injections
Standard Deviation 2.1
|
1.4 Injections
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: 2 yearsIncludes eyes with baseline severity level of 75 (high-risk proliferative diabetic retinopathy) or less based on reading center grading of color fundus photographs using the Early Treatment Diabetic Retinopathy Study severity scale.
Outcome measures
| Measure |
Initiation With Aflibercept
n=185 Eyes
Intravitreal aflibercept at baseline and every 4 weeks as needed (deferred laser may be added to intravitreal aflibercept if certain criteria are met)
Prompt aflibercept: Intravitreal injection of 2.0mg aflibercept performed on the day of randomization and up to every 4 weeks using defined treatment criteria
Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met
|
Initiation With Laser Photocoagulation
n=187 Eyes
Focal/grid laser followed by intravitreal aflibercept if vision worsens
Prompt Laser: Focal/grid laser performed at baseline and as needed during follow-up
Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria
|
Initiation With Observation
n=188 Eyes
No treatment to start followed by intravitreal aflibercept if vision worsens (deferred laser may be added to intravitreal aflibercept if certain criteria are met)
Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met
Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria
|
|---|---|---|---|
|
Number of Eyes With ≥ 2-step Worsening of Diabetic Retinopathy
|
7 Eyes
|
18 Eyes
|
20 Eyes
|
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
| Measure |
Initiation With Aflibercept
n=240 Eyes
Intravitreal aflibercept at baseline and every 4 weeks as needed (deferred laser may be added to intravitreal aflibercept if certain criteria are met)
Prompt aflibercept: Intravitreal injection of 2.0mg aflibercept performed on the day of randomization and up to every 4 weeks using defined treatment criteria
Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met
|
Initiation With Laser Photocoagulation
n=236 Eyes
Focal/grid laser followed by intravitreal aflibercept if vision worsens
Prompt Laser: Focal/grid laser performed at baseline and as needed during follow-up
Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria
|
Initiation With Observation
No treatment to start followed by intravitreal aflibercept if vision worsens (deferred laser may be added to intravitreal aflibercept if certain criteria are met)
Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met
Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria
|
|---|---|---|---|
|
For Eyes Randomized to Initial Laser Photocoagulation and Initial Observation Groups, the Percentage Receiving Aflibercept Treatment
|
60 Eyes
|
80 Eyes
|
—
|
SECONDARY outcome
Timeframe: 2 yearsBest-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/12) to 0 letters (Snellen equivalent of 20/800).
Outcome measures
| Measure |
Initiation With Aflibercept
n=205 Eyes
Intravitreal aflibercept at baseline and every 4 weeks as needed (deferred laser may be added to intravitreal aflibercept if certain criteria are met)
Prompt aflibercept: Intravitreal injection of 2.0mg aflibercept performed on the day of randomization and up to every 4 weeks using defined treatment criteria
Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met
|
Initiation With Laser Photocoagulation
n=212 Eyes
Focal/grid laser followed by intravitreal aflibercept if vision worsens
Prompt Laser: Focal/grid laser performed at baseline and as needed during follow-up
Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria
|
Initiation With Observation
n=208 Eyes
No treatment to start followed by intravitreal aflibercept if vision worsens (deferred laser may be added to intravitreal aflibercept if certain criteria are met)
Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met
Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria
|
|---|---|---|---|
|
Number of Eyes With at Least 5-, 10-, or 15-letter Decrease in E-ETDRS Visual Acuity Letter Score From Baseline
≥ 5-Letter Improvement
|
55 Eyes
|
53 Eyes
|
43 Eyes
|
|
Number of Eyes With at Least 5-, 10-, or 15-letter Decrease in E-ETDRS Visual Acuity Letter Score From Baseline
≥ 10-Letter Worsening
|
18 Eyes
|
14 Eyes
|
14 Eyes
|
|
Number of Eyes With at Least 5-, 10-, or 15-letter Decrease in E-ETDRS Visual Acuity Letter Score From Baseline
≥ 15-Letter Worsening
|
5 Eyes
|
8 Eyes
|
8 Eyes
|
SECONDARY outcome
Timeframe: 2 yearsBest-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/12) to 0 letters (Snellen equivalent of 20/800).
Outcome measures
| Measure |
Initiation With Aflibercept
n=205 Eyes
Intravitreal aflibercept at baseline and every 4 weeks as needed (deferred laser may be added to intravitreal aflibercept if certain criteria are met)
Prompt aflibercept: Intravitreal injection of 2.0mg aflibercept performed on the day of randomization and up to every 4 weeks using defined treatment criteria
Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met
|
Initiation With Laser Photocoagulation
n=212 Eyes
Focal/grid laser followed by intravitreal aflibercept if vision worsens
Prompt Laser: Focal/grid laser performed at baseline and as needed during follow-up
Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria
|
Initiation With Observation
n=208 Eyes
No treatment to start followed by intravitreal aflibercept if vision worsens (deferred laser may be added to intravitreal aflibercept if certain criteria are met)
Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met
Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria
|
|---|---|---|---|
|
Change in E-ETDRS Visual Acuity Letter Score From Baseline
|
0.9 units on a scale
Standard Deviation 6.4
|
0.1 units on a scale
Standard Deviation 6.3
|
-0.4 units on a scale
Standard Deviation 6.4
|
SECONDARY outcome
Timeframe: 1 yearMeasured using spectral-domain optical coherence tomography (OCT).
Outcome measures
| Measure |
Initiation With Aflibercept
n=210 Eyes
Intravitreal aflibercept at baseline and every 4 weeks as needed (deferred laser may be added to intravitreal aflibercept if certain criteria are met)
Prompt aflibercept: Intravitreal injection of 2.0mg aflibercept performed on the day of randomization and up to every 4 weeks using defined treatment criteria
Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met
|
Initiation With Laser Photocoagulation
n=223 Eyes
Focal/grid laser followed by intravitreal aflibercept if vision worsens
Prompt Laser: Focal/grid laser performed at baseline and as needed during follow-up
Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria
|
Initiation With Observation
n=220 Eyes
No treatment to start followed by intravitreal aflibercept if vision worsens (deferred laser may be added to intravitreal aflibercept if certain criteria are met)
Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met
Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria
|
|---|---|---|---|
|
Change in OCT Central Subfield Thickness From Baseline
|
-50 microns
Standard Deviation 55
|
-30 microns
Standard Deviation 69
|
-25 microns
Standard Deviation 73
|
SECONDARY outcome
Timeframe: 2 yearsLogarithmic transformation of optical coherence tomography central subfield thickness is calculated by taking the log base 10 of the ratio of the central subfield thickness divided by 200 and rounding to the nearest hundredth. The change is the change in the log values.
Outcome measures
| Measure |
Initiation With Aflibercept
n=205 Eyes
Intravitreal aflibercept at baseline and every 4 weeks as needed (deferred laser may be added to intravitreal aflibercept if certain criteria are met)
Prompt aflibercept: Intravitreal injection of 2.0mg aflibercept performed on the day of randomization and up to every 4 weeks using defined treatment criteria
Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met
|
Initiation With Laser Photocoagulation
n=212 Eyes
Focal/grid laser followed by intravitreal aflibercept if vision worsens
Prompt Laser: Focal/grid laser performed at baseline and as needed during follow-up
Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria
|
Initiation With Observation
n=207 Eyes
No treatment to start followed by intravitreal aflibercept if vision worsens (deferred laser may be added to intravitreal aflibercept if certain criteria are met)
Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met
Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria
|
|---|---|---|---|
|
Number of Eyes With at Least 1 or 2 Logarithmic-step Central Subfield Thickness Improvement and Worsening
≥ 2 log-step CST decrease (improvement)
|
12 Eyes
|
18 Eyes
|
13 Eyes
|
|
Number of Eyes With at Least 1 or 2 Logarithmic-step Central Subfield Thickness Improvement and Worsening
≥ 1 log-step CST decrease (improvement)
|
57 Eyes
|
56 Eyes
|
61 Eyes
|
|
Number of Eyes With at Least 1 or 2 Logarithmic-step Central Subfield Thickness Improvement and Worsening
≥ 1 log-step CST increase (worsening)
|
6 Eyes
|
10 Eyes
|
11 Eyes
|
|
Number of Eyes With at Least 1 or 2 Logarithmic-step Central Subfield Thickness Improvement and Worsening
≥ 2 log-step CST increase (worsening)
|
1 Eyes
|
1 Eyes
|
2 Eyes
|
SECONDARY outcome
Timeframe: 2 yearsCenter-involved diabetic macular edema defined as follows by central subfield thickness according to optical coherence tomography machine and sex: Heidelberg Spectralis ≥ 305 µm in women and ≥ 320 µm in men, and Zeiss Cirrus ≥ 290 µm in women and ≥ 305 µm in men.
Outcome measures
| Measure |
Initiation With Aflibercept
n=205 Eyes
Intravitreal aflibercept at baseline and every 4 weeks as needed (deferred laser may be added to intravitreal aflibercept if certain criteria are met)
Prompt aflibercept: Intravitreal injection of 2.0mg aflibercept performed on the day of randomization and up to every 4 weeks using defined treatment criteria
Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met
|
Initiation With Laser Photocoagulation
n=212 Eyes
Focal/grid laser followed by intravitreal aflibercept if vision worsens
Prompt Laser: Focal/grid laser performed at baseline and as needed during follow-up
Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria
|
Initiation With Observation
n=207 Eyes
No treatment to start followed by intravitreal aflibercept if vision worsens (deferred laser may be added to intravitreal aflibercept if certain criteria are met)
Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met
Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria
|
|---|---|---|---|
|
Number of Eyes With no Center-involved Diabetic Macular Edema and at Least 10% Central Subfield Thickness Decrease
|
95 Eyes
|
90 Eyes
|
74 Eyes
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: The initial laser session was completed for all eyes in the initial laser group.
Outcome measures
| Measure |
Initiation With Aflibercept
n=205 Eyes
Intravitreal aflibercept at baseline and every 4 weeks as needed (deferred laser may be added to intravitreal aflibercept if certain criteria are met)
Prompt aflibercept: Intravitreal injection of 2.0mg aflibercept performed on the day of randomization and up to every 4 weeks using defined treatment criteria
Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met
|
Initiation With Laser Photocoagulation
n=212 Eyes
Focal/grid laser followed by intravitreal aflibercept if vision worsens
Prompt Laser: Focal/grid laser performed at baseline and as needed during follow-up
Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria
|
Initiation With Observation
n=208 Eyes
No treatment to start followed by intravitreal aflibercept if vision worsens (deferred laser may be added to intravitreal aflibercept if certain criteria are met)
Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met
Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria
|
|---|---|---|---|
|
Cumulative Number of Focal/Grid Photocoagulation Sessions Performed Per Participant
|
0.1 Focal/grid photocoagulation session
Standard Deviation 0.4
|
1.5 Focal/grid photocoagulation session
Standard Deviation 0.9
|
0.0 Focal/grid photocoagulation session
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: 2 yearsIncludes eyes with baseline severity level of 35 (mild non-proliferative diabetic retinopathy) or greater based on reading center grading of color fundus photographs using the Early Treatment Diabetic Retinopathy Study severity scale. Excludes eyes with severity level 60 at baseline since improvement is not possible in these eyes.
Outcome measures
| Measure |
Initiation With Aflibercept
n=165 Eyes
Intravitreal aflibercept at baseline and every 4 weeks as needed (deferred laser may be added to intravitreal aflibercept if certain criteria are met)
Prompt aflibercept: Intravitreal injection of 2.0mg aflibercept performed on the day of randomization and up to every 4 weeks using defined treatment criteria
Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met
|
Initiation With Laser Photocoagulation
n=170 Eyes
Focal/grid laser followed by intravitreal aflibercept if vision worsens
Prompt Laser: Focal/grid laser performed at baseline and as needed during follow-up
Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria
|
Initiation With Observation
n=177 Eyes
No treatment to start followed by intravitreal aflibercept if vision worsens (deferred laser may be added to intravitreal aflibercept if certain criteria are met)
Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met
Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria
|
|---|---|---|---|
|
Number of Eyes With ≥ 2-step Improvement of Diabetic Retinopathy
|
23 Eyes
|
21 Eyes
|
18 Eyes
|
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
| Measure |
Initiation With Aflibercept
n=205 Eyes
Intravitreal aflibercept at baseline and every 4 weeks as needed (deferred laser may be added to intravitreal aflibercept if certain criteria are met)
Prompt aflibercept: Intravitreal injection of 2.0mg aflibercept performed on the day of randomization and up to every 4 weeks using defined treatment criteria
Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met
|
Initiation With Laser Photocoagulation
n=212 Eyes
Focal/grid laser followed by intravitreal aflibercept if vision worsens
Prompt Laser: Focal/grid laser performed at baseline and as needed during follow-up
Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria
|
Initiation With Observation
n=208 Eyes
No treatment to start followed by intravitreal aflibercept if vision worsens (deferred laser may be added to intravitreal aflibercept if certain criteria are met)
Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met
Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria
|
|---|---|---|---|
|
Cumulative Number of Intraocular Injections of 2.0-mg Aflibercept Received Per Participant
|
8.3 Injections
Standard Deviation 4.2
|
2.1 Injections
Standard Deviation 4.0
|
3.1 Injections
Standard Deviation 4.9
|
Adverse Events
Initiation With Laser Photocoagulation
Serious events: 64 serious events
Other events: 194 other events
Deaths: 10 deaths
Initiation With Observation
Serious events: 77 serious events
Other events: 197 other events
Deaths: 9 deaths
Initiation With Aflibercept
Serious events: 69 serious events
Other events: 185 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Initiation With Laser Photocoagulation
n=240 participants at risk
Focal/grid laser followed by intravitreal aflibercept if vision worsens
Prompt Laser: Focal/grid laser performed at baseline and as needed during follow-up
Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria
|
Initiation With Observation
n=236 participants at risk
No treatment to start followed by intravitreal aflibercept if vision worsens (deferred laser may be added to intravitreal aflibercept if certain criteria are met)
Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met
Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria
|
Initiation With Aflibercept
n=226 participants at risk
Intravitreal aflibercept at baseline and every 4 weeks as needed (deferred laser may be added to intravitreal aflibercept if certain criteria are met)
Prompt aflibercept: Intravitreal injection of 2.0mg aflibercept performed on the day of randomization and up to every 4 weeks using defined treatment criteria
Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.83%
2/240 • Number of events 2 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Blood and lymphatic system disorders
Anaemia of chronic disease
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Blood and lymphatic system disorders
Lymphoma
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Blood and lymphatic system disorders
Plasma cell myeloma
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Cardiac disorders
Angina pectoris
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/240 • 2 Years
|
1.3%
3/236 • Number of events 3 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Cardiac disorders
Bicuspid aortic valve
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Cardiac disorders
Bradycardia
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Cardiac disorders
Cardiac arrest
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
Cardiac disorders
Cardiac failure
|
0.42%
1/240 • Number of events 3 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Cardiac disorders
Cardiac failure congestive
|
1.7%
4/240 • Number of events 6 • 2 Years
|
2.1%
5/236 • Number of events 5 • 2 Years
|
2.2%
5/226 • Number of events 5 • 2 Years
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Cardiac disorders
Coronary artery disease
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.85%
2/236 • Number of events 2 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Cardiac disorders
Hypertensive heart disease
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Cardiac disorders
Myocardial infarction
|
0.42%
1/240 • Number of events 1 • 2 Years
|
1.3%
3/236 • Number of events 3 • 2 Years
|
2.2%
5/226 • Number of events 5 • 2 Years
|
|
Endocrine disorders
Diabetes mellitus inadequate control
|
0.00%
0/240 • 2 Years
|
0.85%
2/236 • Number of events 3 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
Endocrine disorders
Diabetic coma
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Endocrine disorders
Diabetic ketoacidosis
|
0.42%
1/240 • Number of events 1 • 2 Years
|
1.3%
3/236 • Number of events 3 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Endocrine disorders
Hyperglycaemia
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
Endocrine disorders
Hypoglycaemia
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
Endocrine disorders
Thyroid cancer
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Eye disorders
Cataract traumatic
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Eye disorders
Rhegmatogenous retinal detachment
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Eye disorders
Vitreous haemorrhage
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Gastrointestinal disorders
Abdominal pain
|
1.2%
3/240 • Number of events 3 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Gastrointestinal disorders
Appendicitis
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Gastrointestinal disorders
Ascites
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
General disorders
Chest discomfort
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
General disorders
Chest pain
|
1.7%
4/240 • Number of events 4 • 2 Years
|
2.5%
6/236 • Number of events 7 • 2 Years
|
1.3%
3/226 • Number of events 3 • 2 Years
|
|
General disorders
Death
|
1.2%
3/240 • Number of events 3 • 2 Years
|
0.85%
2/236 • Number of events 2 • 2 Years
|
1.3%
3/226 • Number of events 3 • 2 Years
|
|
General disorders
Fatigue
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
General disorders
Flank pain
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
General disorders
Hernia
|
0.00%
0/240 • 2 Years
|
0.85%
2/236 • Number of events 2 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
General disorders
Multi-organ failure
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
General disorders
Oedema peripheral
|
1.2%
3/240 • Number of events 4 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
General disorders
Peripheral swelling
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.85%
2/236 • Number of events 2 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Hepatobiliary disorders
Liver abscess
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 2 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Infections and infestations
Abscess
|
0.83%
2/240 • Number of events 2 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Infections and infestations
Infection
|
1.7%
4/240 • Number of events 4 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
Infections and infestations
Influenza
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Infections and infestations
Localised infection
|
0.83%
2/240 • Number of events 2 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Infections and infestations
Sepsis
|
0.83%
2/240 • Number of events 2 • 2 Years
|
0.85%
2/236 • Number of events 2 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Injury, poisoning and procedural complications
Back injury
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Injury, poisoning and procedural complications
Fall
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Injury, poisoning and procedural complications
Heat exhaustion
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Investigations
Blood creatinine abnormal
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Investigations
Blood electrolytes decreased
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Investigations
Blood glucose decreased
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Investigations
Blood glucose increased
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Investigations
Blood potassium increased
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Investigations
Troponin increased
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
1.3%
3/226 • Number of events 3 • 2 Years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.42%
1/240 • Number of events 1 • 2 Years
|
1.3%
3/236 • Number of events 3 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Hip fracture
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Lower limb fracture
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Multiple fractures
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.7%
4/240 • Number of events 4 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Osteomyelitis
|
0.00%
0/240 • 2 Years
|
0.85%
2/236 • Number of events 2 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Rib fracture
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Vertebral foraminal stenosis
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Nervous system disorders
Aphasia
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Nervous system disorders
Carotid artery occlusion
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Nervous system disorders
Concussion
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Nervous system disorders
Convulsion
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Nervous system disorders
Hypoglycaemic encephalopathy
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Nervous system disorders
Seizure
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Nervous system disorders
Syncope
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 2 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Renal and urinary disorders
Acute kidney injury
|
0.83%
2/240 • Number of events 2 • 2 Years
|
1.3%
3/236 • Number of events 3 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Renal and urinary disorders
Cardiorenal syndrome
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.42%
1/240 • Number of events 2 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
Renal and urinary disorders
Cystitis
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Renal and urinary disorders
End stage renal disease
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Renal and urinary disorders
Kidney infection
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.83%
2/240 • Number of events 2 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Renal and urinary disorders
Nephropathy
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Renal and urinary disorders
Pyelonephritis
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Renal and urinary disorders
Renal failure
|
0.83%
2/240 • Number of events 2 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
1.3%
3/226 • Number of events 3 • 2 Years
|
|
Renal and urinary disorders
Renal failure acute
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.85%
2/236 • Number of events 2 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Renal and urinary disorders
Renal failure chronic
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Renal and urinary disorders
Renal impairment
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Renal and urinary disorders
Urinary tract infection
|
1.7%
4/240 • Number of events 4 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Reproductive system and breast disorders
Breast cancer
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.42%
1/240 • Number of events 1 • 2 Years
|
1.3%
3/236 • Number of events 3 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.83%
2/240 • Number of events 2 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Lung neoplasm malignant
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 2 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.7%
4/240 • Number of events 4 • 2 Years
|
1.3%
3/236 • Number of events 3 • 2 Years
|
1.8%
4/226 • Number of events 4 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.2%
3/240 • Number of events 3 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
2.7%
6/226 • Number of events 7 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
1.2%
3/240 • Number of events 3 • 2 Years
|
0.85%
2/236 • Number of events 2 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Diabetic ulcer
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Gangrene
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Herpes zoster
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Surgical and medical procedures
Abdominal hernia repair
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Surgical and medical procedures
Cardiac operation
|
0.83%
2/240 • Number of events 2 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Surgical and medical procedures
Cardiac pacemaker insertion
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Surgical and medical procedures
Carpal tunnel decompression
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Surgical and medical procedures
Cholecystectomy
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Surgical and medical procedures
Coronary arterial stent insertion
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Surgical and medical procedures
Coronary artery bypass
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
Surgical and medical procedures
Gastric banding
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Surgical and medical procedures
Gastric bypass
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Surgical and medical procedures
Hysterectomy
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Surgical and medical procedures
Implantable defibrillator insertion
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
1.3%
3/226 • Number of events 3 • 2 Years
|
|
Surgical and medical procedures
Knee operation
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
1.3%
3/226 • Number of events 3 • 2 Years
|
|
Surgical and medical procedures
Leg amputation
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Surgical and medical procedures
Stent placement
|
0.00%
0/240 • 2 Years
|
0.85%
2/236 • Number of events 2 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Surgical and medical procedures
Surgery
|
1.2%
3/240 • Number of events 3 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Surgical and medical procedures
Toe amputation
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Surgical and medical procedures
Vascular graft
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Vascular disorders
Arteriovenous fistula
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Vascular disorders
Carotid artery disease
|
1.2%
3/240 • Number of events 3 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Vascular disorders
Cerebral haemorrhage
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Vascular disorders
Cerebrovascular accident
|
2.1%
5/240 • Number of events 5 • 2 Years
|
1.3%
3/236 • Number of events 3 • 2 Years
|
1.3%
3/226 • Number of events 3 • 2 Years
|
|
Vascular disorders
Embolism
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Vascular disorders
Haematoma
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Vascular disorders
Haemorrhagic stroke
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Vascular disorders
Hypertension
|
0.83%
2/240 • Number of events 2 • 2 Years
|
1.3%
3/236 • Number of events 3 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Vascular disorders
Hypotension
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Vascular disorders
Ischaemic stroke
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Vascular disorders
Poor peripheral circulation
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Vascular disorders
Transient ischaemic attack
|
1.2%
3/240 • Number of events 3 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
Other adverse events
| Measure |
Initiation With Laser Photocoagulation
n=240 participants at risk
Focal/grid laser followed by intravitreal aflibercept if vision worsens
Prompt Laser: Focal/grid laser performed at baseline and as needed during follow-up
Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria
|
Initiation With Observation
n=236 participants at risk
No treatment to start followed by intravitreal aflibercept if vision worsens (deferred laser may be added to intravitreal aflibercept if certain criteria are met)
Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met
Deferred aflibercept: Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria
|
Initiation With Aflibercept
n=226 participants at risk
Intravitreal aflibercept at baseline and every 4 weeks as needed (deferred laser may be added to intravitreal aflibercept if certain criteria are met)
Prompt aflibercept: Intravitreal injection of 2.0mg aflibercept performed on the day of randomization and up to every 4 weeks using defined treatment criteria
Deferred laser: Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.5%
6/240 • Number of events 6 • 2 Years
|
3.8%
9/236 • Number of events 9 • 2 Years
|
1.8%
4/226 • Number of events 4 • 2 Years
|
|
Blood and lymphatic system disorders
Anaemia of chronic disease
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.83%
2/240 • Number of events 2 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Blood and lymphatic system disorders
Lymphoedema
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Cardiac disorders
Arrhythmia
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/240 • 2 Years
|
0.85%
2/236 • Number of events 2 • 2 Years
|
1.3%
3/226 • Number of events 3 • 2 Years
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
1.3%
3/226 • Number of events 3 • 2 Years
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.83%
2/240 • Number of events 3 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Cardiac disorders
Cardiac failure
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Cardiac disorders
Cardiac failure congestive
|
2.1%
5/240 • Number of events 6 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Cardiac disorders
Coronary artery disease
|
0.83%
2/240 • Number of events 2 • 2 Years
|
1.7%
4/236 • Number of events 4 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Cardiac disorders
Long QT syndrome
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Cardiac disorders
Palpitations
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
1.3%
3/226 • Number of events 3 • 2 Years
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Ear and labyrinth disorders
Deafness
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Ear and labyrinth disorders
Ear infection
|
1.7%
4/240 • Number of events 4 • 2 Years
|
2.1%
5/236 • Number of events 5 • 2 Years
|
1.8%
4/226 • Number of events 4 • 2 Years
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Ear and labyrinth disorders
Mastoiditis
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Ear and labyrinth disorders
Meniere's disease
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Ear and labyrinth disorders
Otitis externa
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Ear and labyrinth disorders
Tinnitus
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Endocrine disorders
Diabetes mellitus
|
3.8%
9/240 • Number of events 11 • 2 Years
|
3.4%
8/236 • Number of events 8 • 2 Years
|
1.8%
4/226 • Number of events 5 • 2 Years
|
|
Endocrine disorders
Diabetes mellitus inadequate control
|
3.8%
9/240 • Number of events 10 • 2 Years
|
3.0%
7/236 • Number of events 8 • 2 Years
|
3.1%
7/226 • Number of events 7 • 2 Years
|
|
Endocrine disorders
Diabetic ketoacidosis
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Endocrine disorders
Goitre
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Endocrine disorders
Hyperglycaemia
|
0.83%
2/240 • Number of events 2 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
Endocrine disorders
Hyperparathyroidism
|
0.00%
0/240 • 2 Years
|
0.85%
2/236 • Number of events 2 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Endocrine disorders
Hyperthyroidism
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Endocrine disorders
Hypoglycaemia
|
0.83%
2/240 • Number of events 2 • 2 Years
|
0.00%
0/236 • 2 Years
|
1.8%
4/226 • Number of events 6 • 2 Years
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/240 • 2 Years
|
2.5%
6/236 • Number of events 6 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
Endocrine disorders
Pituitary tumour benign
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Endocrine disorders
Thyroid neoplasm
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
1.3%
3/226 • Number of events 3 • 2 Years
|
|
Eye disorders
Age-related macular degeneration
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Eye disorders
Altered visual depth perception
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Eye disorders
Amaurosis fugax
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Eye disorders
Angle closure glaucoma
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Eye disorders
Asthenopia
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Eye disorders
Blepharitis
|
0.83%
2/240 • Number of events 3 • 2 Years
|
1.3%
3/236 • Number of events 3 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Eye disorders
Blepharospasm
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Eye disorders
Borderline glaucoma
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Eye disorders
Cataract
|
5.8%
14/240 • Number of events 14 • 2 Years
|
5.9%
14/236 • Number of events 15 • 2 Years
|
7.5%
17/226 • Number of events 17 • 2 Years
|
|
Eye disorders
Cataract cortical
|
2.5%
6/240 • Number of events 6 • 2 Years
|
2.5%
6/236 • Number of events 6 • 2 Years
|
4.9%
11/226 • Number of events 11 • 2 Years
|
|
Eye disorders
Cataract nuclear
|
1.7%
4/240 • Number of events 4 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
3.5%
8/226 • Number of events 8 • 2 Years
|
|
Eye disorders
Cataract subcapsular
|
1.7%
4/240 • Number of events 4 • 2 Years
|
1.7%
4/236 • Number of events 6 • 2 Years
|
4.9%
11/226 • Number of events 13 • 2 Years
|
|
Eye disorders
Chalazion
|
0.83%
2/240 • Number of events 2 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Eye disorders
Choroidal neovascularisation
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Eye disorders
Conjunctival haemorrhage
|
3.3%
8/240 • Number of events 11 • 2 Years
|
3.8%
9/236 • Number of events 13 • 2 Years
|
7.5%
17/226 • Number of events 23 • 2 Years
|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/240 • 2 Years
|
1.3%
3/236 • Number of events 3 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
Eye disorders
Conjunctivitis allergic
|
0.83%
2/240 • Number of events 2 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
Eye disorders
Conjunctivitis viral
|
0.83%
2/240 • Number of events 2 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Eye disorders
Corneal abrasion
|
0.83%
2/240 • Number of events 2 • 2 Years
|
0.85%
2/236 • Number of events 3 • 2 Years
|
1.3%
3/226 • Number of events 4 • 2 Years
|
|
Eye disorders
Corneal defect
|
0.42%
1/240 • Number of events 2 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Eye disorders
Corneal disorder
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Eye disorders
Corneal dystrophy
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
Eye disorders
Corneal erosion
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Eye disorders
Corneal oedema
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Eye disorders
Corneal opacity
|
0.42%
1/240 • Number of events 2 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Eye disorders
Corneal pigmentation
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Eye disorders
Corneal scar
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Eye disorders
Cystoid macular oedema
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Eye disorders
Diabetic retinal oedema
|
2.5%
6/240 • Number of events 6 • 2 Years
|
3.0%
7/236 • Number of events 7 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
Eye disorders
Diabetic retinopathy
|
2.5%
6/240 • Number of events 7 • 2 Years
|
0.85%
2/236 • Number of events 2 • 2 Years
|
2.2%
5/226 • Number of events 5 • 2 Years
|
|
Eye disorders
Diplopia
|
3.3%
8/240 • Number of events 8 • 2 Years
|
0.85%
2/236 • Number of events 2 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Eye disorders
Dry eye
|
4.6%
11/240 • Number of events 12 • 2 Years
|
3.4%
8/236 • Number of events 10 • 2 Years
|
7.5%
17/226 • Number of events 18 • 2 Years
|
|
Eye disorders
Eye discharge
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.85%
2/236 • Number of events 2 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Eye disorders
Eye irritation
|
2.5%
6/240 • Number of events 6 • 2 Years
|
3.0%
7/236 • Number of events 7 • 2 Years
|
5.3%
12/226 • Number of events 13 • 2 Years
|
|
Eye disorders
Eye pain
|
2.1%
5/240 • Number of events 8 • 2 Years
|
4.7%
11/236 • Number of events 14 • 2 Years
|
7.1%
16/226 • Number of events 19 • 2 Years
|
|
Eye disorders
Eye pruritus
|
3.8%
9/240 • Number of events 10 • 2 Years
|
1.3%
3/236 • Number of events 3 • 2 Years
|
2.7%
6/226 • Number of events 6 • 2 Years
|
|
Eye disorders
Eye swelling
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Eye disorders
Eyelid margin crusting
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Eye disorders
Eyelid oedema
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Eye disorders
Eyelid pain
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Eye disorders
Eyelid ptosis
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Eye disorders
Foreign body in eye
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Eye disorders
Foreign body sensation in eyes
|
0.83%
2/240 • Number of events 3 • 2 Years
|
1.3%
3/236 • Number of events 3 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
Eye disorders
Glare
|
2.5%
6/240 • Number of events 6 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Eye disorders
Hordeolum
|
2.1%
5/240 • Number of events 5 • 2 Years
|
0.85%
2/236 • Number of events 2 • 2 Years
|
0.44%
1/226 • Number of events 2 • 2 Years
|
|
Eye disorders
Hyalosis asteroid
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Eye disorders
Hyphaema
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Eye disorders
Iris adhesions
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Eye disorders
Iris neovascularisation
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Eye disorders
Iritis
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
Eye disorders
Keratitis
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Eye disorders
Keratopathy
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Eye disorders
Lacrimation increased
|
3.8%
9/240 • Number of events 9 • 2 Years
|
3.4%
8/236 • Number of events 10 • 2 Years
|
3.5%
8/226 • Number of events 8 • 2 Years
|
|
Eye disorders
Macular degeneration
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Eye disorders
Macular fibrosis
|
4.2%
10/240 • Number of events 10 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
2.7%
6/226 • Number of events 7 • 2 Years
|
|
Eye disorders
Macular ischaemia
|
0.00%
0/240 • 2 Years
|
1.3%
3/236 • Number of events 3 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Eye disorders
Macular oedema
|
0.83%
2/240 • Number of events 2 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Eye disorders
Meibomian gland dysfunction
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Eye disorders
Metamorphopsia
|
1.2%
3/240 • Number of events 3 • 2 Years
|
0.85%
2/236 • Number of events 2 • 2 Years
|
1.3%
3/226 • Number of events 4 • 2 Years
|
|
Eye disorders
Ocular discomfort
|
1.2%
3/240 • Number of events 3 • 2 Years
|
1.3%
3/236 • Number of events 4 • 2 Years
|
3.1%
7/226 • Number of events 7 • 2 Years
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/240 • 2 Years
|
1.3%
3/236 • Number of events 3 • 2 Years
|
2.7%
6/226 • Number of events 6 • 2 Years
|
|
Eye disorders
Ocular hypertension
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Eye disorders
Ophthalmic herpes simplex
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Eye disorders
Optic atrophy
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Eye disorders
Optic ischaemic neuropathy
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Eye disorders
Optic nerve cupping
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Eye disorders
Photophobia
|
1.7%
4/240 • Number of events 4 • 2 Years
|
3.0%
7/236 • Number of events 8 • 2 Years
|
3.5%
8/226 • Number of events 8 • 2 Years
|
|
Eye disorders
Photopsia
|
1.2%
3/240 • Number of events 3 • 2 Years
|
1.7%
4/236 • Number of events 4 • 2 Years
|
3.1%
7/226 • Number of events 7 • 2 Years
|
|
Eye disorders
Posterior capsule opacification
|
1.2%
3/240 • Number of events 3 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
Eye disorders
Punctate keratitis
|
1.2%
3/240 • Number of events 3 • 2 Years
|
0.85%
2/236 • Number of events 3 • 2 Years
|
1.8%
4/226 • Number of events 4 • 2 Years
|
|
Eye disorders
Retinal aneurysm
|
1.2%
3/240 • Number of events 3 • 2 Years
|
2.1%
5/236 • Number of events 5 • 2 Years
|
1.3%
3/226 • Number of events 3 • 2 Years
|
|
Eye disorders
Retinal artery embolism
|
0.83%
2/240 • Number of events 2 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Eye disorders
Retinal detachment
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Eye disorders
Retinal exudates
|
2.1%
5/240 • Number of events 6 • 2 Years
|
5.1%
12/236 • Number of events 12 • 2 Years
|
3.1%
7/226 • Number of events 7 • 2 Years
|
|
Eye disorders
Retinal haemorrhage
|
0.83%
2/240 • Number of events 2 • 2 Years
|
4.2%
10/236 • Number of events 11 • 2 Years
|
1.8%
4/226 • Number of events 4 • 2 Years
|
|
Eye disorders
Retinal ischaemia
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Eye disorders
Retinal neovascularisation
|
2.1%
5/240 • Number of events 5 • 2 Years
|
1.3%
3/236 • Number of events 3 • 2 Years
|
0.88%
2/226 • Number of events 3 • 2 Years
|
|
Eye disorders
Retinal oedema
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Eye disorders
Retinal pigment epitheliopathy
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Eye disorders
Retinal tear
|
0.83%
2/240 • Number of events 2 • 2 Years
|
0.85%
2/236 • Number of events 2 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Eye disorders
Retinal vein occlusion
|
0.83%
2/240 • Number of events 2 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Eye disorders
Retinopathy
|
0.00%
0/240 • 2 Years
|
0.85%
2/236 • Number of events 2 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Eye disorders
Retinopathy hypertensive
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Eye disorders
Rhegmatogenous retinal detachment
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Eye disorders
Subretinal fibrosis
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Eye disorders
Ulcerative keratitis
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Eye disorders
Vision blurred
|
12.9%
31/240 • Number of events 39 • 2 Years
|
14.4%
34/236 • Number of events 43 • 2 Years
|
17.7%
40/226 • Number of events 46 • 2 Years
|
|
Eye disorders
Visual acuity reduced
|
6.2%
15/240 • Number of events 16 • 2 Years
|
6.8%
16/236 • Number of events 16 • 2 Years
|
2.7%
6/226 • Number of events 6 • 2 Years
|
|
Eye disorders
Visual field defect
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Eye disorders
Visual impairment
|
4.6%
11/240 • Number of events 12 • 2 Years
|
4.7%
11/236 • Number of events 13 • 2 Years
|
4.0%
9/226 • Number of events 11 • 2 Years
|
|
Eye disorders
Vitreous adhesions
|
0.00%
0/240 • 2 Years
|
1.3%
3/236 • Number of events 3 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
Eye disorders
Vitreous detachment
|
1.2%
3/240 • Number of events 3 • 2 Years
|
1.7%
4/236 • Number of events 4 • 2 Years
|
5.3%
12/226 • Number of events 12 • 2 Years
|
|
Eye disorders
Vitreous disorder
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Eye disorders
Vitreous floaters
|
6.7%
16/240 • Number of events 16 • 2 Years
|
8.9%
21/236 • Number of events 22 • 2 Years
|
11.9%
27/226 • Number of events 34 • 2 Years
|
|
Eye disorders
Vitreous haemorrhage
|
2.5%
6/240 • Number of events 7 • 2 Years
|
2.1%
5/236 • Number of events 5 • 2 Years
|
3.5%
8/226 • Number of events 11 • 2 Years
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.83%
2/240 • Number of events 2 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
Gastrointestinal disorders
Abdominal distension
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Gastrointestinal disorders
Abdominal pain
|
0.42%
1/240 • Number of events 2 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/240 • 2 Years
|
1.3%
3/236 • Number of events 3 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
Gastrointestinal disorders
Appendicitis
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Gastrointestinal disorders
Colon adenoma
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Gastrointestinal disorders
Colon cancer
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Gastrointestinal disorders
Constipation
|
1.7%
4/240 • Number of events 4 • 2 Years
|
1.3%
3/236 • Number of events 4 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Gastrointestinal disorders
Dental caries
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Gastrointestinal disorders
Diabetic gastroparesis
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Gastrointestinal disorders
Diarrhoea
|
2.5%
6/240 • Number of events 6 • 2 Years
|
2.5%
6/236 • Number of events 6 • 2 Years
|
3.5%
8/226 • Number of events 9 • 2 Years
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Gastrointestinal disorders
Dyspepsia
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/240 • 2 Years
|
0.85%
2/236 • Number of events 2 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
Gastrointestinal disorders
Gastroenteritis viral
|
0.83%
2/240 • Number of events 2 • 2 Years
|
1.3%
3/236 • Number of events 3 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.1%
5/240 • Number of events 5 • 2 Years
|
2.5%
6/236 • Number of events 6 • 2 Years
|
3.1%
7/226 • Number of events 7 • 2 Years
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
1.3%
3/226 • Number of events 3 • 2 Years
|
|
Gastrointestinal disorders
Nausea
|
4.6%
11/240 • Number of events 12 • 2 Years
|
3.4%
8/236 • Number of events 9 • 2 Years
|
3.1%
7/226 • Number of events 8 • 2 Years
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Gastrointestinal disorders
Salivary gland disorder
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Gastrointestinal disorders
Tooth abscess
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
1.8%
4/226 • Number of events 4 • 2 Years
|
|
Gastrointestinal disorders
Tooth fracture
|
1.2%
3/240 • Number of events 3 • 2 Years
|
0.00%
0/236 • 2 Years
|
1.3%
3/226 • Number of events 3 • 2 Years
|
|
Gastrointestinal disorders
Tooth infection
|
1.2%
3/240 • Number of events 3 • 2 Years
|
0.85%
2/236 • Number of events 2 • 2 Years
|
1.8%
4/226 • Number of events 5 • 2 Years
|
|
Gastrointestinal disorders
Tooth loss
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Gastrointestinal disorders
Toothache
|
0.83%
2/240 • Number of events 3 • 2 Years
|
0.00%
0/236 • 2 Years
|
2.7%
6/226 • Number of events 7 • 2 Years
|
|
Gastrointestinal disorders
Vomiting
|
2.5%
6/240 • Number of events 6 • 2 Years
|
1.7%
4/236 • Number of events 4 • 2 Years
|
3.1%
7/226 • Number of events 8 • 2 Years
|
|
General disorders
Chest discomfort
|
0.83%
2/240 • Number of events 2 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
General disorders
Chest pain
|
1.7%
4/240 • Number of events 4 • 2 Years
|
3.0%
7/236 • Number of events 7 • 2 Years
|
1.3%
3/226 • Number of events 4 • 2 Years
|
|
General disorders
Chills
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
General disorders
Cyst
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
General disorders
Fatigue
|
1.2%
3/240 • Number of events 3 • 2 Years
|
1.7%
4/236 • Number of events 4 • 2 Years
|
2.2%
5/226 • Number of events 5 • 2 Years
|
|
General disorders
Flank pain
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
General disorders
Hernia
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
General disorders
Injection site discomfort
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
General disorders
Injection site irritation
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
General disorders
Lethargy
|
0.00%
0/240 • 2 Years
|
0.85%
2/236 • Number of events 2 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
General disorders
Local swelling
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 2 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
General disorders
Necrosis
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
General disorders
Oedema peripheral
|
3.3%
8/240 • Number of events 10 • 2 Years
|
3.4%
8/236 • Number of events 8 • 2 Years
|
1.3%
3/226 • Number of events 3 • 2 Years
|
|
General disorders
Pain
|
1.2%
3/240 • Number of events 3 • 2 Years
|
0.85%
2/236 • Number of events 2 • 2 Years
|
1.8%
4/226 • Number of events 5 • 2 Years
|
|
General disorders
Peripheral swelling
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.85%
2/236 • Number of events 2 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
General disorders
Pyrexia
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.85%
2/236 • Number of events 2 • 2 Years
|
2.7%
6/226 • Number of events 6 • 2 Years
|
|
General disorders
Swelling
|
0.83%
2/240 • Number of events 2 • 2 Years
|
1.3%
3/236 • Number of events 3 • 2 Years
|
1.8%
4/226 • Number of events 4 • 2 Years
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Hepatobiliary disorders
Cholangitis
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/240 • 2 Years
|
1.3%
3/236 • Number of events 3 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Hepatobiliary disorders
Non-alcoholic steatohepatitis
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/240 • 2 Years
|
0.85%
2/236 • Number of events 2 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
Immune system disorders
Seasonal allergy
|
2.9%
7/240 • Number of events 7 • 2 Years
|
0.85%
2/236 • Number of events 2 • 2 Years
|
2.7%
6/226 • Number of events 6 • 2 Years
|
|
Immune system disorders
Systemic lupus erythematosus
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
Immune system disorders
Urticaria
|
0.00%
0/240 • 2 Years
|
1.3%
3/236 • Number of events 3 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Infections and infestations
Abscess
|
0.00%
0/240 • 2 Years
|
1.3%
3/236 • Number of events 3 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
Infections and infestations
Candida infection
|
0.00%
0/240 • 2 Years
|
0.85%
2/236 • Number of events 2 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Infections and infestations
Fungal infection
|
0.83%
2/240 • Number of events 2 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/240 • 2 Years
|
0.85%
2/236 • Number of events 2 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Infections and infestations
Infection
|
1.7%
4/240 • Number of events 4 • 2 Years
|
0.85%
2/236 • Number of events 2 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
Infections and infestations
Influenza
|
2.9%
7/240 • Number of events 7 • 2 Years
|
3.8%
9/236 • Number of events 10 • 2 Years
|
4.4%
10/226 • Number of events 11 • 2 Years
|
|
Infections and infestations
Localised infection
|
1.2%
3/240 • Number of events 3 • 2 Years
|
0.85%
2/236 • Number of events 2 • 2 Years
|
3.5%
8/226 • Number of events 10 • 2 Years
|
|
Infections and infestations
Onychomycosis
|
0.42%
1/240 • Number of events 1 • 2 Years
|
1.3%
3/236 • Number of events 3 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Infections and infestations
Oral herpes
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Infections and infestations
Respiratory tract infection fungal
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Infections and infestations
Sepsis
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
1.3%
3/226 • Number of events 4 • 2 Years
|
|
Infections and infestations
Streptococcal infection
|
0.83%
2/240 • Number of events 2 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.85%
2/236 • Number of events 2 • 2 Years
|
2.2%
5/226 • Number of events 5 • 2 Years
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Injury, poisoning and procedural complications
Chemical injury
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Injury, poisoning and procedural complications
Fall
|
2.1%
5/240 • Number of events 5 • 2 Years
|
2.1%
5/236 • Number of events 8 • 2 Years
|
1.8%
4/226 • Number of events 4 • 2 Years
|
|
Injury, poisoning and procedural complications
Head injury
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Injury, poisoning and procedural complications
Injury
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.85%
2/236 • Number of events 2 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.42%
1/240 • Number of events 2 • 2 Years
|
0.85%
2/236 • Number of events 2 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Injury, poisoning and procedural complications
Laceration
|
1.2%
3/240 • Number of events 3 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
1.8%
4/226 • Number of events 4 • 2 Years
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Injury, poisoning and procedural complications
Limb injury
|
1.7%
4/240 • Number of events 4 • 2 Years
|
0.85%
2/236 • Number of events 2 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Injury, poisoning and procedural complications
Limb traumatic amputation
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.42%
1/240 • Number of events 1 • 2 Years
|
1.3%
3/236 • Number of events 3 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
1.3%
3/226 • Number of events 4 • 2 Years
|
|
Investigations
Biopsy skin
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Investigations
Blood creatine increased
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Investigations
Blood creatinine abnormal
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Investigations
Blood glucose decreased
|
0.00%
0/240 • 2 Years
|
0.85%
2/236 • Number of events 2 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Investigations
Blood glucose increased
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Investigations
Blood lactic acid increased
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Investigations
Blood potassium increased
|
0.00%
0/240 • 2 Years
|
0.85%
2/236 • Number of events 2 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Investigations
Blood testosterone decreased
|
0.83%
2/240 • Number of events 2 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Investigations
Carotid bruit
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Investigations
Echocardiogram abnormal
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Investigations
Free prostate-specific antigen increased
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Investigations
Glycosylated haemoglobin increased
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Investigations
Heart rate irregular
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Investigations
Intraocular pressure increased
|
0.83%
2/240 • Number of events 2 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
1.3%
3/226 • Number of events 3 • 2 Years
|
|
Investigations
Laboratory test abnormal
|
0.00%
0/240 • 2 Years
|
0.85%
2/236 • Number of events 9 • 2 Years
|
0.88%
2/226 • Number of events 3 • 2 Years
|
|
Investigations
Low density lipoprotein increased
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Investigations
Protein urine present
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Metabolism and nutrition disorders
Abnormal weight gain
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.85%
2/236 • Number of events 2 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
1.3%
3/226 • Number of events 3 • 2 Years
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
1.7%
4/240 • Number of events 5 • 2 Years
|
2.1%
5/236 • Number of events 5 • 2 Years
|
3.1%
7/226 • Number of events 7 • 2 Years
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
1.3%
3/226 • Number of events 3 • 2 Years
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.83%
2/240 • Number of events 2 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.42%
1/240 • Number of events 1 • 2 Years
|
1.7%
4/236 • Number of events 4 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.83%
2/240 • Number of events 2 • 2 Years
|
0.85%
2/236 • Number of events 2 • 2 Years
|
1.3%
3/226 • Number of events 3 • 2 Years
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/240 • 2 Years
|
1.3%
3/236 • Number of events 3 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
1.2%
3/240 • Number of events 3 • 2 Years
|
3.4%
8/236 • Number of events 8 • 2 Years
|
1.3%
3/226 • Number of events 3 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Ankle fracture
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Ankylosing spondylitis
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.6%
11/240 • Number of events 11 • 2 Years
|
4.2%
10/236 • Number of events 11 • 2 Years
|
3.1%
7/226 • Number of events 8 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
2.1%
5/240 • Number of events 6 • 2 Years
|
2.1%
5/236 • Number of events 5 • 2 Years
|
1.3%
3/226 • Number of events 3 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Arthritis bacterial
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
12/240 • Number of events 14 • 2 Years
|
3.4%
8/236 • Number of events 8 • 2 Years
|
4.0%
9/226 • Number of events 10 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/240 • 2 Years
|
0.85%
2/236 • Number of events 2 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's contracture
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Foot fracture
|
0.83%
2/240 • Number of events 2 • 2 Years
|
0.85%
2/236 • Number of events 2 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Gout
|
0.83%
2/240 • Number of events 2 • 2 Years
|
0.85%
2/236 • Number of events 2 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Hand fracture
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.83%
2/240 • Number of events 2 • 2 Years
|
1.3%
3/236 • Number of events 3 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Joint dislocation
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Ligament sprain
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.85%
2/236 • Number of events 2 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Lipoma
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Meniscus injury
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Multiple fractures
|
0.00%
0/240 • 2 Years
|
0.85%
2/236 • Number of events 2 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.5%
6/240 • Number of events 6 • 2 Years
|
1.3%
3/236 • Number of events 3 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Muscle strain
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/240 • 2 Years
|
0.85%
2/236 • Number of events 2 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.1%
5/240 • Number of events 6 • 2 Years
|
2.1%
5/236 • Number of events 6 • 2 Years
|
1.3%
3/226 • Number of events 3 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.83%
2/240 • Number of events 2 • 2 Years
|
1.3%
3/236 • Number of events 3 • 2 Years
|
1.3%
3/226 • Number of events 4 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Myokymia
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.83%
2/240 • Number of events 2 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Neuropathic arthropathy
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Osteomyelitis
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.88%
2/226 • Number of events 3 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
1.2%
3/240 • Number of events 3 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.5%
6/240 • Number of events 6 • 2 Years
|
4.7%
11/236 • Number of events 14 • 2 Years
|
4.4%
10/226 • Number of events 10 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/240 • 2 Years
|
0.85%
2/236 • Number of events 2 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Rib fracture
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Stiff person syndrome
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.83%
2/240 • Number of events 3 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
1.8%
4/226 • Number of events 8 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Wrist fracture
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Abdominal neoplasm
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papilloma
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland neoplasm
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/240 • 2 Years
|
1.7%
4/236 • Number of events 4 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Nervous system disorders
Apraxia
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Nervous system disorders
Autonomic neuropathy
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Nervous system disorders
Balance disorder
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.85%
2/236 • Number of events 2 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Nervous system disorders
Benign intracranial hypertension
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.83%
2/240 • Number of events 3 • 2 Years
|
0.85%
2/236 • Number of events 2 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Nervous system disorders
Cervical radiculopathy
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Nervous system disorders
Concussion
|
1.2%
3/240 • Number of events 3 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Nervous system disorders
Diabetic neuropathy
|
0.83%
2/240 • Number of events 2 • 2 Years
|
3.0%
7/236 • Number of events 7 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Nervous system disorders
Dizziness
|
2.1%
5/240 • Number of events 5 • 2 Years
|
3.0%
7/236 • Number of events 8 • 2 Years
|
3.1%
7/226 • Number of events 8 • 2 Years
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Nervous system disorders
Head discomfort
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Nervous system disorders
Headache
|
2.9%
7/240 • Number of events 8 • 2 Years
|
5.9%
14/236 • Number of events 16 • 2 Years
|
6.6%
15/226 • Number of events 17 • 2 Years
|
|
Nervous system disorders
Hemiplegia
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Nervous system disorders
Hypoaesthesia
|
1.2%
3/240 • Number of events 3 • 2 Years
|
1.3%
3/236 • Number of events 3 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Nervous system disorders
Lumbar spinal stenosis
|
0.00%
0/240 • 2 Years
|
1.3%
3/236 • Number of events 3 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
Nervous system disorders
Migraine
|
1.7%
4/240 • Number of events 5 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
2.2%
5/226 • Number of events 5 • 2 Years
|
|
Nervous system disorders
Migraine with aura
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Nervous system disorders
Myasthenia gravis
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Nervous system disorders
Nerve compression
|
0.42%
1/240 • Number of events 1 • 2 Years
|
1.3%
3/236 • Number of events 3 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Nervous system disorders
Nerve injury
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Nervous system disorders
Neuropathy peripheral
|
2.1%
5/240 • Number of events 5 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
Nervous system disorders
Paraesthesia
|
0.83%
2/240 • Number of events 2 • 2 Years
|
1.3%
3/236 • Number of events 3 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Nervous system disorders
Presyncope
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Nervous system disorders
Sciatica
|
1.7%
4/240 • Number of events 4 • 2 Years
|
1.3%
3/236 • Number of events 3 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
Nervous system disorders
Seizure
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
Nervous system disorders
Somnolence
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Nervous system disorders
Syncope
|
0.83%
2/240 • Number of events 2 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
Nervous system disorders
Tension headache
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Nervous system disorders
Tremor
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Nervous system disorders
Ulnar nerve injury
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Nervous system disorders
VIth nerve paralysis
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Nervous system disorders
Vertigo
|
2.9%
7/240 • Number of events 7 • 2 Years
|
2.5%
6/236 • Number of events 7 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Psychiatric disorders
Anxiety
|
1.2%
3/240 • Number of events 4 • 2 Years
|
2.5%
6/236 • Number of events 6 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Psychiatric disorders
Confusional state
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Psychiatric disorders
Depression
|
2.1%
5/240 • Number of events 5 • 2 Years
|
1.3%
3/236 • Number of events 4 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
Psychiatric disorders
Insomnia
|
1.2%
3/240 • Number of events 3 • 2 Years
|
1.3%
3/236 • Number of events 3 • 2 Years
|
1.3%
3/226 • Number of events 3 • 2 Years
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Psychiatric disorders
Panic attack
|
0.83%
2/240 • Number of events 2 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Psychiatric disorders
Stress
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Renal and urinary disorders
Acute kidney injury
|
1.2%
3/240 • Number of events 3 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Renal and urinary disorders
Acute prerenal failure
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Renal and urinary disorders
Anuria
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Renal and urinary disorders
Bladder cancer
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Renal and urinary disorders
Chronic kidney disease
|
2.1%
5/240 • Number of events 5 • 2 Years
|
2.1%
5/236 • Number of events 5 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Renal and urinary disorders
Cystitis
|
1.2%
3/240 • Number of events 3 • 2 Years
|
0.85%
2/236 • Number of events 2 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Renal and urinary disorders
Haematuria
|
0.83%
2/240 • Number of events 3 • 2 Years
|
0.85%
2/236 • Number of events 2 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 3 • 2 Years
|
|
Renal and urinary disorders
Kidney infection
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Renal and urinary disorders
Microalbuminuria
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Renal and urinary disorders
Nephritis
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.85%
2/236 • Number of events 2 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Renal and urinary disorders
Oliguria
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Renal and urinary disorders
Proteinuria
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.85%
2/236 • Number of events 3 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Renal and urinary disorders
Pyelonephritis
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Renal and urinary disorders
Renal failure
|
2.1%
5/240 • Number of events 5 • 2 Years
|
1.3%
3/236 • Number of events 3 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
Renal and urinary disorders
Renal failure chronic
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Renal and urinary disorders
Renal pain
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Renal and urinary disorders
Urinary incontinence
|
0.83%
2/240 • Number of events 2 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
Renal and urinary disorders
Urinary retention
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Renal and urinary disorders
Urinary tract infection
|
5.4%
13/240 • Number of events 17 • 2 Years
|
2.1%
5/236 • Number of events 6 • 2 Years
|
2.7%
6/226 • Number of events 8 • 2 Years
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Reproductive system and breast disorders
Breast cancer
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Reproductive system and breast disorders
Breast cyst
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Reproductive system and breast disorders
Epididymitis
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Reproductive system and breast disorders
Prostate cancer
|
0.83%
2/240 • Number of events 2 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Reproductive system and breast disorders
Testicular disorder
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Reproductive system and breast disorders
Uterine leiomyoma
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Acute sinusitis
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.7%
4/240 • Number of events 9 • 2 Years
|
0.00%
0/236 • 2 Years
|
1.8%
4/226 • Number of events 6 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiolitis
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
3.3%
8/240 • Number of events 8 • 2 Years
|
6.8%
16/236 • Number of events 19 • 2 Years
|
4.0%
9/226 • Number of events 10 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.2%
10/240 • Number of events 10 • 2 Years
|
3.0%
7/236 • Number of events 9 • 2 Years
|
3.5%
8/226 • Number of events 11 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.83%
2/240 • Number of events 3 • 2 Years
|
0.85%
2/236 • Number of events 2 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.83%
2/240 • Number of events 2 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Laryngitis
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.42%
1/240 • Number of events 1 • 2 Years
|
1.7%
4/236 • Number of events 5 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
4.6%
11/240 • Number of events 13 • 2 Years
|
6.4%
15/236 • Number of events 16 • 2 Years
|
10.2%
23/226 • Number of events 26 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.83%
2/240 • Number of events 2 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis streptococcal
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.85%
2/236 • Number of events 2 • 2 Years
|
1.3%
3/226 • Number of events 3 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.42%
1/240 • Number of events 1 • 2 Years
|
1.3%
3/236 • Number of events 3 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
4.2%
10/240 • Number of events 10 • 2 Years
|
2.1%
5/236 • Number of events 5 • 2 Years
|
1.8%
4/226 • Number of events 4 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/240 • 2 Years
|
0.85%
2/236 • Number of events 2 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract infection
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
1.3%
3/226 • Number of events 3 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
5.4%
13/240 • Number of events 20 • 2 Years
|
4.2%
10/236 • Number of events 10 • 2 Years
|
3.1%
7/226 • Number of events 7 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
1.2%
3/240 • Number of events 4 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
1.3%
3/226 • Number of events 3 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
5.4%
13/240 • Number of events 16 • 2 Years
|
5.1%
12/236 • Number of events 13 • 2 Years
|
3.5%
8/226 • Number of events 9 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/240 • 2 Years
|
0.85%
2/236 • Number of events 2 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Basal cell carcinoma
|
0.83%
2/240 • Number of events 4 • 2 Years
|
1.7%
4/236 • Number of events 4 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
1.3%
3/226 • Number of events 3 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
1.2%
3/240 • Number of events 3 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
2.7%
6/226 • Number of events 6 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Contusion
|
1.2%
3/240 • Number of events 3 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Cutis laxa
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
1.2%
3/240 • Number of events 3 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Dermatophytosis
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
1.7%
4/240 • Number of events 4 • 2 Years
|
1.3%
3/236 • Number of events 3 • 2 Years
|
2.2%
5/226 • Number of events 5 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Diabetic ulcer
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Folliculitis
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Furuncle
|
1.2%
3/240 • Number of events 3 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Herpes zoster
|
2.1%
5/240 • Number of events 5 • 2 Years
|
0.85%
2/236 • Number of events 2 • 2 Years
|
2.7%
6/226 • Number of events 6 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
1.2%
3/240 • Number of events 3 • 2 Years
|
0.85%
2/236 • Number of events 2 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Malignant melanoma
|
0.83%
2/240 • Number of events 2 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Nail avulsion
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Onychogryphosis
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.2%
3/240 • Number of events 3 • 2 Years
|
1.7%
4/236 • Number of events 4 • 2 Years
|
1.8%
4/226 • Number of events 4 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Skin abrasion
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Skin bacterial infection
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Skin cancer
|
0.83%
2/240 • Number of events 2 • 2 Years
|
0.42%
1/236 • Number of events 2 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Skin infection
|
1.7%
4/240 • Number of events 4 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/240 • 2 Years
|
1.7%
4/236 • Number of events 4 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.83%
2/240 • Number of events 2 • 2 Years
|
1.3%
3/236 • Number of events 3 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Surgical and medical procedures
Arterial bypass operation
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Surgical and medical procedures
Benign tumour excision
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Surgical and medical procedures
Bile duct stent insertion
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Surgical and medical procedures
Blepharoplasty
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Surgical and medical procedures
Carpal tunnel decompression
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.85%
2/236 • Number of events 2 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Surgical and medical procedures
Cataract operation
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Surgical and medical procedures
Cholecystectomy
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Surgical and medical procedures
Coronary arterial stent insertion
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Surgical and medical procedures
Dental implantation
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Surgical and medical procedures
Endodontic procedure
|
0.00%
0/240 • 2 Years
|
0.85%
2/236 • Number of events 2 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
Surgical and medical procedures
Hysterectomy
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Surgical and medical procedures
Knee operation
|
0.83%
2/240 • Number of events 3 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Surgical and medical procedures
Metatarsal excision
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Surgical and medical procedures
Retinal laser coagulation
|
0.83%
2/240 • Number of events 2 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Surgical and medical procedures
Shoulder operation
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Surgical and medical procedures
Skin graft
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Surgical and medical procedures
Skin lesion excision
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Surgical and medical procedures
Spinal decompression
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
Surgical and medical procedures
Stent placement
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
Surgical and medical procedures
Surgery
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
Surgical and medical procedures
Tooth extraction
|
0.83%
2/240 • Number of events 2 • 2 Years
|
0.85%
2/236 • Number of events 2 • 2 Years
|
1.3%
3/226 • Number of events 3 • 2 Years
|
|
Surgical and medical procedures
Transfusion
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Surgical and medical procedures
Wrist surgery
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Vascular disorders
Arteriovenous fistula
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.44%
1/226 • Number of events 2 • 2 Years
|
|
Vascular disorders
Carotid artery stenosis
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/240 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.44%
1/226 • Number of events 1 • 2 Years
|
|
Vascular disorders
Essential hypertension
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Vascular disorders
Haematoma
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Vascular disorders
Hypertension
|
8.3%
20/240 • Number of events 20 • 2 Years
|
7.6%
18/236 • Number of events 20 • 2 Years
|
5.8%
13/226 • Number of events 13 • 2 Years
|
|
Vascular disorders
Hypotension
|
1.2%
3/240 • Number of events 3 • 2 Years
|
0.85%
2/236 • Number of events 2 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Vascular disorders
Poor peripheral circulation
|
0.42%
1/240 • Number of events 1 • 2 Years
|
0.00%
0/236 • 2 Years
|
0.88%
2/226 • Number of events 2 • 2 Years
|
|
Vascular disorders
Transient ischaemic attack
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
|
Vascular disorders
Varicose vein
|
0.00%
0/240 • 2 Years
|
0.42%
1/236 • Number of events 1 • 2 Years
|
0.00%
0/226 • 2 Years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place