Trial Outcomes & Findings for Prompt Panretinal Photocoagulation Versus Ranibizumab+Deferred Panretinal Photocoagulation for Proliferative Diabetic Retinopathy (NCT NCT01489189)
NCT ID: NCT01489189
Last Updated: 2021-10-29
Results Overview
Visual acuity is measured as a continuous integer letter score from 0 to 100, with higher numbers indicating better visual acuity. A letter score of 85 is approximately 20/20 and a letter score of 70 is approximately 20/40, the legal unrestricted driving limit in most states. A 5-letter change for an individual is approximately equal to a 1-line change on a vision chart.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
305 participants
Primary outcome timeframe
2-years
Results posted on
2021-10-29
Participant Flow
Participants with 2 eyes in the study had 1 eye randomly assigned to receive ranibizumab and 1 eye to receive panretinal photocoagulation. Two-year completed visits include those that occurred between 644 and 812 days (between 92 and 116 weeks).
Participant milestones
| Measure |
Anti-VEGF+Deferred PRP
Anti vascular endothelial growth factor (Anti-VEGF). Panretinal photocoagulation (PRP). Intravitreal anti-VEGF with PRP only if indicated.
0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met.
|
Prompt PRP
Panretinal Photocoagulation (PRP). PRP alone.
Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days).
|
|---|---|---|
|
Overall Study
STARTED
|
191
|
203
|
|
Overall Study
COMPLETED
|
160
|
168
|
|
Overall Study
NOT COMPLETED
|
31
|
35
|
Reasons for withdrawal
| Measure |
Anti-VEGF+Deferred PRP
Anti vascular endothelial growth factor (Anti-VEGF). Panretinal photocoagulation (PRP). Intravitreal anti-VEGF with PRP only if indicated.
0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met.
|
Prompt PRP
Panretinal Photocoagulation (PRP). PRP alone.
Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days).
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
20
|
23
|
|
Overall Study
Death
|
10
|
8
|
|
Overall Study
Missed Visit
|
1
|
4
|
Baseline Characteristics
Prompt Panretinal Photocoagulation Versus Ranibizumab+Deferred Panretinal Photocoagulation for Proliferative Diabetic Retinopathy
Baseline characteristics by cohort
| Measure |
Anti-VEGF+Deferred PRP
n=191 Participants
Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.
0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met.
|
Prompt PRP
n=203 Participants
PRP= Panretinal Photocoagulation. PRP alone.
Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days).
|
Total
n=394 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
52 years
n=5 Participants
|
51 years
n=7 Participants
|
51 years
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
83 eyes
n=5 Participants
|
92 eyes
n=7 Participants
|
175 eyes
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
108 eyes
n=5 Participants
|
111 eyes
n=7 Participants
|
219 eyes
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
100 eyes
n=5 Participants
|
101 eyes
n=7 Participants
|
201 eyes
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
48 eyes
n=5 Participants
|
51 eyes
n=7 Participants
|
99 eyes
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
38 eyes
n=5 Participants
|
43 eyes
n=7 Participants
|
81 eyes
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 eyes
n=5 Participants
|
3 eyes
n=7 Participants
|
5 eyes
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaskan Native
|
1 eyes
n=5 Participants
|
0 eyes
n=7 Participants
|
1 eyes
n=5 Participants
|
|
Race/Ethnicity, Customized
More than 1 race
|
0 eyes
n=5 Participants
|
2 eyes
n=7 Participants
|
2 eyes
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown/not reported
|
2 eyes
n=5 Participants
|
3 eyes
n=7 Participants
|
5 eyes
n=5 Participants
|
|
Number of study eyes
One
|
102 eyes
n=5 Participants
|
114 eyes
n=7 Participants
|
216 eyes
n=5 Participants
|
|
Number of study eyes
Two (one in each group)
|
89 eyes
n=5 Participants
|
89 eyes
n=7 Participants
|
178 eyes
n=5 Participants
|
|
Diabetes Type
Type 1
|
43 eyes
n=5 Participants
|
41 eyes
n=7 Participants
|
84 eyes
n=5 Participants
|
|
Diabetes Type
Type 2
|
140 eyes
n=5 Participants
|
155 eyes
n=7 Participants
|
295 eyes
n=5 Participants
|
|
Diabetes Type
Uncertain
|
8 eyes
n=5 Participants
|
7 eyes
n=7 Participants
|
15 eyes
n=5 Participants
|
|
Duration of Diabetes
|
18 years
n=5 Participants
|
17 years
n=7 Participants
|
18 years
n=5 Participants
|
|
Hemoglobin A1c
|
8.6 percent
n=5 Participants
|
8.9 percent
n=7 Participants
|
8.7 percent
n=5 Participants
|
|
Prior Myocardial Infarction
|
3 eyes
n=5 Participants
|
4 eyes
n=7 Participants
|
7 eyes
n=5 Participants
|
|
Prior Stroke
|
4 eyes
n=5 Participants
|
3 eyes
n=7 Participants
|
7 eyes
n=5 Participants
|
|
Arterial Blood Pressure
|
99 mmHg
n=5 Participants
|
99 mmHg
n=7 Participants
|
99 mmHg
n=5 Participants
|
|
Visual Acuity
|
75 letters
STANDARD_DEVIATION 12.8 • n=5 Participants
|
75.2 letters
STANDARD_DEVIATION 12.5 • n=7 Participants
|
75.1 letters
STANDARD_DEVIATION 12.6 • n=5 Participants
|
|
Optical Coherence Tomography Central Subfield Thickness
|
223 µm
n=5 Participants
|
230 µm
n=7 Participants
|
229 µm
n=5 Participants
|
|
Presence of Center-Involved Diabetic Macular Edema with Visual Acuity Impairment
|
42 eyes
n=5 Participants
|
46 eyes
n=7 Participants
|
88 eyes
n=5 Participants
|
|
Presence of Center-Involved Diabetic Macular Edema Regardless of Visual Acuity
|
55 eyes
n=5 Participants
|
62 eyes
n=7 Participants
|
117 eyes
n=5 Participants
|
|
Neovascularization on Clinical Examination
Of the disc
|
96 eyes
n=5 Participants
|
103 eyes
n=7 Participants
|
199 eyes
n=5 Participants
|
|
Neovascularization on Clinical Examination
Elsewhere
|
166 eyes
n=5 Participants
|
174 eyes
n=7 Participants
|
340 eyes
n=5 Participants
|
|
Phakic Lens Status on Clinical Exam
|
170 eyes
n=5 Participants
|
187 eyes
n=7 Participants
|
357 eyes
n=5 Participants
|
|
Diabetic Retinopathy Severity
Microaneurysms only (level 20)
|
0 eyes
n=5 Participants
|
1 eyes
n=7 Participants
|
1 eyes
n=5 Participants
|
|
Diabetic Retinopathy Severity
Mild NPDR (level 35)
|
6 eyes
n=5 Participants
|
4 eyes
n=7 Participants
|
10 eyes
n=5 Participants
|
|
Diabetic Retinopathy Severity
Moderate NPDR (level 43)
|
2 eyes
n=5 Participants
|
5 eyes
n=7 Participants
|
7 eyes
n=5 Participants
|
|
Diabetic Retinopathy Severity
Moderately severe NPDR (level 47)
|
10 eyes
n=5 Participants
|
15 eyes
n=7 Participants
|
25 eyes
n=5 Participants
|
|
Diabetic Retinopathy Severity
Severe NPDR (level 53)
|
1 eyes
n=5 Participants
|
1 eyes
n=7 Participants
|
2 eyes
n=5 Participants
|
|
Diabetic Retinopathy Severity
Prior PRP without active PDR (level 60)
|
0 eyes
n=5 Participants
|
1 eyes
n=7 Participants
|
1 eyes
n=5 Participants
|
|
Diabetic Retinopathy Severity
Mild PDR (level 61)
|
30 eyes
n=5 Participants
|
31 eyes
n=7 Participants
|
61 eyes
n=5 Participants
|
|
Diabetic Retinopathy Severity
Moderate PDR (level 65)
|
68 eyes
n=5 Participants
|
67 eyes
n=7 Participants
|
135 eyes
n=5 Participants
|
|
Diabetic Retinopathy Severity
High-risk PDR (levels 71 and 75)
|
69 eyes
n=5 Participants
|
73 eyes
n=7 Participants
|
142 eyes
n=5 Participants
|
|
Diabetic Retinopathy Severity
Advanced PDR, macular center attached (level 81)
|
2 eyes
n=5 Participants
|
0 eyes
n=7 Participants
|
2 eyes
n=5 Participants
|
|
Diabetic Retinopathy Severity
Advanced PDR, macular center detached (level 85)
|
1 eyes
n=5 Participants
|
1 eyes
n=7 Participants
|
2 eyes
n=5 Participants
|
|
Prior treatment for diabetic macular edema (DME)
|
43 eyes
n=5 Participants
|
36 eyes
n=7 Participants
|
79 eyes
n=5 Participants
|
|
Prior focal/grid laser treatment for DME
|
30 eyes
n=5 Participants
|
29 eyes
n=7 Participants
|
59 eyes
n=5 Participants
|
|
Prior anti-VEGF treatment for DME
|
21 eyes
n=5 Participants
|
13 eyes
n=7 Participants
|
34 eyes
n=5 Participants
|
PRIMARY outcome
Timeframe: 2-yearsPopulation: Participants that completed the 2-year visit.
Visual acuity is measured as a continuous integer letter score from 0 to 100, with higher numbers indicating better visual acuity. A letter score of 85 is approximately 20/20 and a letter score of 70 is approximately 20/40, the legal unrestricted driving limit in most states. A 5-letter change for an individual is approximately equal to a 1-line change on a vision chart.
Outcome measures
| Measure |
Anti-VEGF+Deferred PRP
n=160 Eyes
Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.
0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met.
|
Prompt PRP
n=168 Eyes
PRP= Panretinal Photocoagulation. PRP alone.
Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days).
|
|---|---|---|
|
Mean Change in Visual Acuity From Baseline
|
2.8 letters
Interval 0.4 to 5.2
|
0.2 letters
Interval -1.9 to 2.3
|
SECONDARY outcome
Timeframe: 2-yearsPopulation: Participants that completed the 2-year visit.
Visual acuity is measured as a continuous integer letter score from 0 to 100, with higher numbers indicating better visual acuity. A letter score of 85 is approximately 20/20 and a letter score of 70 is approximately 20/40, the legal unrestricted driving limit in most states. A 5-letter change for an individual is approximately equal to a 1-line change on a vision chart.
Outcome measures
| Measure |
Anti-VEGF+Deferred PRP
n=160 Eyes
Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.
0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met.
|
Prompt PRP
n=168 Eyes
PRP= Panretinal Photocoagulation. PRP alone.
Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days).
|
|---|---|---|
|
Mean Visual Acuity
|
78.7 letters
Standard Deviation 16.3
|
76.2 letters
Standard Deviation 14.1
|
SECONDARY outcome
Timeframe: 2-yearsPopulation: Eyes with a baseline letter score of 78 or less (approximate Snellen equivalent 20/32 or worse) from participants that completed the 2-year visit.
Outcome measures
| Measure |
Anti-VEGF+Deferred PRP
n=81 Eyes
Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.
0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met.
|
Prompt PRP
n=86 Eyes
PRP= Panretinal Photocoagulation. PRP alone.
Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days).
|
|---|---|---|
|
Number of Eyes With Greater Than or Equal to 10 Letter Vision Gain
|
35 eyes
|
31 eyes
|
SECONDARY outcome
Timeframe: 2-yearsPopulation: Humphrey visual fields were obtained at a subset of sites. Fields with excessive false positive response, excessive false negative response, or excessive fixation loss were excluded from analysis. Twenty-two eyes in the anti-VEGF+deferred PRP group and 25 eyes in the prompt PRP group were excluded.
Visual fields, collected using the Humphrey Visual Field analyzer, measured the total point score (sum of retinal sensitivities of all points) tested on 30-2 and 60-4 patterns, which included the mid-peripheral and peripheral visual fields. A lower score indicates greater visual field loss.The cumulative score is the sum of all visual field sensitivity values for each of the four individual quadrants of the visual field (the quadrants are divided by the horizontal and vertical lines). The range can be from 0 to about 600 for the 30-2 test \[for each quadrant\], and from 0 to about 400 or 450 for the peripheral test.
Outcome measures
| Measure |
Anti-VEGF+Deferred PRP
n=58 Eyes
Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.
0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met.
|
Prompt PRP
n=57 Eyes
PRP= Panretinal Photocoagulation. PRP alone.
Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days).
|
|---|---|---|
|
Humphrey Visual Field Test Cumulative Score Change From Baseline
|
-25 decibels
Interval -232.0 to 223.0
|
-379 decibels
Interval -723.0 to -75.0
|
SECONDARY outcome
Timeframe: 2-yearsOutcome measures
| Measure |
Anti-VEGF+Deferred PRP
n=191 Eyes
Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.
0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met.
|
Prompt PRP
n=203 Eyes
PRP= Panretinal Photocoagulation. PRP alone.
Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days).
|
|---|---|---|
|
Frequency of Vitrectomy
|
8 eyes
|
30 eyes
|
SECONDARY outcome
Timeframe: 2-yearsPopulation: Eyes with optical coherence tomography (OCT) data at baseline and 2-years.
All baseline and 2-year optical coherence tomography (OCT) scans were evaluated by the OCT reading center.
Outcome measures
| Measure |
Anti-VEGF+Deferred PRP
n=149 Eyes
Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.
0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met.
|
Prompt PRP
n=161 Eyes
PRP= Panretinal Photocoagulation. PRP alone.
Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days).
|
|---|---|---|
|
Mean Change in OCT Central Subfield Thickness From Baseline
|
-47 µm
Interval -61.0 to -33.0
|
-3 µm
Interval -15.0 to 9.0
|
SECONDARY outcome
Timeframe: 2-yearsPopulation: Excludes that did not have central DME with vision impairment (20/32 or worse) at baseline.
Outcome measures
| Measure |
Anti-VEGF+Deferred PRP
n=147 Eyes
Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.
0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met.
|
Prompt PRP
n=155 Eyes
PRP= Panretinal Photocoagulation. PRP alone.
Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days).
|
|---|---|---|
|
Development of Central DME With Vision Impairment by 2-years
|
15 eyes
|
42 eyes
|
SECONDARY outcome
Timeframe: 2-yearsOutcome measures
| Measure |
Anti-VEGF+Deferred PRP
n=191 Eyes
Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.
0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met.
|
Prompt PRP
n=203 Eyes
PRP= Panretinal Photocoagulation. PRP alone.
Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days).
|
|---|---|---|
|
Number of Eyes With Vitreous Hemorrhage
|
52 Eyes
|
69 Eyes
|
SECONDARY outcome
Timeframe: 2-yearsPopulation: Eyes with baseline diabetic retinopathy level 61B or worse (active neovascularization). Last-observation-carried-forward was used for 23 eyes in the anti-VEGF+Deferred PRP group and 25 eyes in the Prompt PRP group missing photographs at 2 years if 1-year fundus photographs were available.
Outcome measures
| Measure |
Anti-VEGF+Deferred PRP
n=142 Eyes
Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.
0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met.
|
Prompt PRP
n=148 Eyes
PRP= Panretinal Photocoagulation. PRP alone.
Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days).
|
|---|---|---|
|
Number of Eyes Without Active or Regressed Neovascularization on Fundus Photography at 2-years
|
49 eyes
|
44 eyes
|
SECONDARY outcome
Timeframe: 2-yearPopulation: Participants that completed the 2-year visit.
Outcome measures
| Measure |
Anti-VEGF+Deferred PRP
n=160 Eyes
Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.
0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met.
|
Prompt PRP
n=168 Eyes
PRP= Panretinal Photocoagulation. PRP alone.
Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days).
|
|---|---|---|
|
Number of Eyes With Greater Than or Equal to 10 Letter Vision Loss
|
15 eyes
|
23 eyes
|
Adverse Events
Bilateral Participants
Serious events: 36 serious events
Other events: 85 other events
Deaths: 0 deaths
Anti-VEGF+Deferred PRP
Serious events: 50 serious events
Other events: 96 other events
Deaths: 0 deaths
Prompt PRP
Serious events: 43 serious events
Other events: 105 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bilateral Participants
n=89 participants at risk
Participants with one eye enrolled in each arm of the study.
|
Anti-VEGF+Deferred PRP
n=102 participants at risk
Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.
0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met.
|
Prompt PRP
n=114 participants at risk
PRP= Panretinal Photocoagulation. PRP alone.
Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days).
|
|---|---|---|---|
|
Renal and urinary disorders
Renal failure chronic
|
1.1%
1/89
|
3.9%
4/102
|
2.6%
3/114
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/89
|
2.9%
3/102
|
0.00%
0/114
|
|
Renal and urinary disorders
Urinary retention
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Renal and urinary disorders
Urinary tract infection
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/89
|
2.0%
2/102
|
0.00%
0/114
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
4.5%
4/89
|
3.9%
4/102
|
1.8%
2/114
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Blood and lymphatic system disorders
Leukaemia
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/89
|
2.0%
2/102
|
0.00%
0/114
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/89
|
0.98%
1/102
|
0.88%
1/114
|
|
Cardiac disorders
Cardiac failure congestive
|
2.2%
2/89
|
5.9%
6/102
|
1.8%
2/114
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Cardiac disorders
Coronary artery disease
|
2.2%
2/89
|
0.98%
1/102
|
0.88%
1/114
|
|
Cardiac disorders
Coronary artery restenosis
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Cardiac disorders
Coronary artery stenosis
|
1.1%
1/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Cardiac disorders
Diastolic dysfunction
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Cardiac disorders
Myocardial infarction
|
3.4%
3/89
|
2.9%
3/102
|
1.8%
2/114
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Ear and labyrinth disorders
Inner ear disorder
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Endocrine disorders
Diabetes mellitus
|
0.00%
0/89
|
2.0%
2/102
|
0.00%
0/114
|
|
Endocrine disorders
Diabetes mellitus inadequate control
|
1.1%
1/89
|
2.0%
2/102
|
0.88%
1/114
|
|
Endocrine disorders
Diabetic ketoacidosis
|
0.00%
0/89
|
3.9%
4/102
|
2.6%
3/114
|
|
Endocrine disorders
Hyperglycaemia
|
2.2%
2/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Endocrine disorders
Hypoglycaemia
|
1.1%
1/89
|
0.98%
1/102
|
0.88%
1/114
|
|
Eye disorders
Angle closure glaucoma
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Eye disorders
Endophthalmitis
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Eye disorders
Ocular hypertension
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/89
|
0.98%
1/102
|
0.88%
1/114
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/89
|
2.0%
2/102
|
0.00%
0/114
|
|
Gastrointestinal disorders
Diabetic gastroparesis
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Gastrointestinal disorders
Gastritis
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/89
|
0.98%
1/102
|
0.88%
1/114
|
|
Gastrointestinal disorders
Gastroenteritis viral
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/89
|
0.00%
0/102
|
1.8%
2/114
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
1/89
|
0.98%
1/102
|
0.00%
0/114
|
|
General disorders
Chest pain
|
2.2%
2/89
|
4.9%
5/102
|
2.6%
3/114
|
|
General disorders
Death
|
1.1%
1/89
|
2.9%
3/102
|
1.8%
2/114
|
|
General disorders
Hernia
|
1.1%
1/89
|
0.00%
0/102
|
0.88%
1/114
|
|
General disorders
Local swelling
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
General disorders
Oedema peripheral
|
0.00%
0/89
|
0.98%
1/102
|
0.88%
1/114
|
|
General disorders
Pain
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Hepatobiliary disorders
Cholecystitis acute
|
1.1%
1/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/89
|
0.98%
1/102
|
0.88%
1/114
|
|
Infections and infestations
Abscess
|
1.1%
1/89
|
0.98%
1/102
|
0.88%
1/114
|
|
Infections and infestations
Beta haemolytic streptococcal infection
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Infections and infestations
Diverticulitis
|
1.1%
1/89
|
2.0%
2/102
|
0.00%
0/114
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Infections and infestations
Infection
|
0.00%
0/89
|
0.98%
1/102
|
0.88%
1/114
|
|
Infections and infestations
Influenza
|
1.1%
1/89
|
0.98%
1/102
|
0.88%
1/114
|
|
Infections and infestations
Localised infection
|
4.5%
4/89
|
2.9%
3/102
|
0.88%
1/114
|
|
Infections and infestations
Postoperative wound infection
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Infections and infestations
Sepsis
|
2.2%
2/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Investigations
Blood creatinine abnormal
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Investigations
Blood glucose decreased
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Investigations
Colonoscopy
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Metabolism and nutrition disorders
Dehydration
|
1.1%
1/89
|
0.98%
1/102
|
0.88%
1/114
|
|
Metabolism and nutrition disorders
Fluid overload
|
2.2%
2/89
|
2.0%
2/102
|
0.00%
0/114
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Musculoskeletal and connective tissue disorders
Ankle fracture
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Musculoskeletal and connective tissue disorders
Foot fracture
|
0.00%
0/89
|
2.0%
2/102
|
0.88%
1/114
|
|
Musculoskeletal and connective tissue disorders
Fractured coccyx
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Musculoskeletal and connective tissue disorders
Gout
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Musculoskeletal and connective tissue disorders
Multiple fractures
|
0.00%
0/89
|
0.98%
1/102
|
0.88%
1/114
|
|
Musculoskeletal and connective tissue disorders
Osteomyelitis
|
2.2%
2/89
|
2.0%
2/102
|
0.88%
1/114
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/89
|
0.00%
0/102
|
1.8%
2/114
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Musculoskeletal and connective tissue disorders
Wrist fracture
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Nervous system disorders
Autonomic nervous system imbalance
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Nervous system disorders
Brain neoplasm
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Nervous system disorders
Convulsion
|
1.1%
1/89
|
0.98%
1/102
|
0.88%
1/114
|
|
Nervous system disorders
Encephalopathy
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Nervous system disorders
Headache
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Nervous system disorders
Syncope
|
0.00%
0/89
|
2.9%
3/102
|
0.88%
1/114
|
|
Nervous system disorders
Tremor
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Nervous system disorders
Vertigo
|
0.00%
0/89
|
0.00%
0/102
|
1.8%
2/114
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Renal and urinary disorders
Cystitis
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Renal and urinary disorders
Haematuria
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Renal and urinary disorders
Nephrolithiasis
|
2.2%
2/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Renal and urinary disorders
Nephrotic Syndrome
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Renal and urinary disorders
Pyelonephritis
|
2.2%
2/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Renal and urinary disorders
Renal failure
|
1.1%
1/89
|
6.9%
7/102
|
1.8%
2/114
|
|
Renal and urinary disorders
Renal failure acute
|
2.2%
2/89
|
2.0%
2/102
|
0.00%
0/114
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract oedema
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
1.1%
1/89
|
2.0%
2/102
|
1.8%
2/114
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
2.2%
2/89
|
2.0%
2/102
|
0.00%
0/114
|
|
Skin and subcutaneous tissue disorders
Gangrene
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Skin and subcutaneous tissue disorders
Herpes zoster
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Skin and subcutaneous tissue disorders
Skin infection
|
1.1%
1/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Surgical and medical procedures
Cardiac operation
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Surgical and medical procedures
Coronary angioplasty
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Surgical and medical procedures
Coronary artery bypass
|
0.00%
0/89
|
0.98%
1/102
|
0.88%
1/114
|
|
Surgical and medical procedures
Knee operation
|
0.00%
0/89
|
0.00%
0/102
|
1.8%
2/114
|
|
Surgical and medical procedures
Leg amputation
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Surgical and medical procedures
Stent placement
|
1.1%
1/89
|
0.98%
1/102
|
0.88%
1/114
|
|
Surgical and medical procedures
Surgery
|
1.1%
1/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Surgical and medical procedures
Toe amputation
|
0.00%
0/89
|
2.9%
3/102
|
0.00%
0/114
|
|
Surgical and medical procedures
Tonsillectomy
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Vascular disorders
Carotid artery disease
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Vascular disorders
Cerebrovascular accident
|
1.1%
1/89
|
2.0%
2/102
|
2.6%
3/114
|
|
Vascular disorders
Embolism
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Vascular disorders
Hypertension
|
1.1%
1/89
|
2.0%
2/102
|
2.6%
3/114
|
|
Vascular disorders
Hypotension
|
1.1%
1/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Vascular disorders
Ischaemic stroke
|
0.00%
0/89
|
0.00%
0/102
|
1.8%
2/114
|
|
Vascular disorders
Peripheral ischaemia
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Vascular disorders
Peripheral vascular disorder
|
1.1%
1/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Vascular disorders
Thrombosis
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Vascular disorders
Transient ischaemic attack
|
0.00%
0/89
|
2.0%
2/102
|
0.88%
1/114
|
Other adverse events
| Measure |
Bilateral Participants
n=89 participants at risk
Participants with one eye enrolled in each arm of the study.
|
Anti-VEGF+Deferred PRP
n=102 participants at risk
Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.
0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met.
|
Prompt PRP
n=114 participants at risk
PRP= Panretinal Photocoagulation. PRP alone.
Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days).
|
|---|---|---|---|
|
Eye disorders
Eye swelling
|
1.1%
1/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Eye disorders
Eye pruritus
|
7.9%
7/89
|
7.8%
8/102
|
9.6%
11/114
|
|
Blood and lymphatic system disorders
Anaemia
|
7.9%
7/89
|
8.8%
9/102
|
5.3%
6/114
|
|
Blood and lymphatic system disorders
Anaemia of chronic disease
|
2.2%
2/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Blood and lymphatic system disorders
Leukocytosis
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Blood and lymphatic system disorders
Lymphoedema
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/89
|
2.0%
2/102
|
0.00%
0/114
|
|
Cardiac disorders
Atrial flutter
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Cardiac disorders
Cardiac failure
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Cardiac disorders
Cardiac failure congestive
|
2.2%
2/89
|
2.0%
2/102
|
0.00%
0/114
|
|
Cardiac disorders
Coronary artery disease
|
2.2%
2/89
|
4.9%
5/102
|
0.88%
1/114
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Cardiac disorders
Ventricular hypokinesia
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Ear and labyrinth disorders
Deafness
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/89
|
0.98%
1/102
|
0.88%
1/114
|
|
Ear and labyrinth disorders
Ear infection
|
1.1%
1/89
|
3.9%
4/102
|
1.8%
2/114
|
|
Ear and labyrinth disorders
Ear pain
|
3.4%
3/89
|
2.0%
2/102
|
0.88%
1/114
|
|
Ear and labyrinth disorders
Eustachian tube dysfunction
|
0.00%
0/89
|
0.98%
1/102
|
0.88%
1/114
|
|
Ear and labyrinth disorders
Middle ear effusion
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Ear and labyrinth disorders
Otitis media
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Ear and labyrinth disorders
Otitis media acute
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Ear and labyrinth disorders
Tinnitus
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Endocrine disorders
Cushing's syndrome
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Endocrine disorders
Diabetes mellitus
|
3.4%
3/89
|
2.9%
3/102
|
1.8%
2/114
|
|
Endocrine disorders
Diabetes mellitus inadequate control
|
7.9%
7/89
|
4.9%
5/102
|
3.5%
4/114
|
|
Endocrine disorders
Diabetic ketoacidosis
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Endocrine disorders
Hyperglycaemia
|
3.4%
3/89
|
5.9%
6/102
|
2.6%
3/114
|
|
Endocrine disorders
Hyperthyroidism
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Endocrine disorders
Hypoglycaemia
|
1.1%
1/89
|
7.8%
8/102
|
0.00%
0/114
|
|
Endocrine disorders
Hypothyroidism
|
3.4%
3/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Endocrine disorders
Thyroid neoplasm
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Eye disorders
Abnormal sensation in eye
|
1.1%
1/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Eye disorders
Accommodation disorder
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Eye disorders
Altered visual depth perception
|
0.00%
0/89
|
0.00%
0/102
|
1.8%
2/114
|
|
Eye disorders
Angle closure glaucoma
|
2.2%
2/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Eye disorders
Anterior chamber cell
|
3.4%
3/89
|
0.98%
1/102
|
0.88%
1/114
|
|
Eye disorders
Anterior chamber flare
|
0.00%
0/89
|
0.00%
0/102
|
1.8%
2/114
|
|
Eye disorders
Aphakia
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Eye disorders
Asthenopia
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Eye disorders
Blepharal papilloma
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Eye disorders
Blepharitis
|
3.4%
3/89
|
2.0%
2/102
|
0.00%
0/114
|
|
Eye disorders
Blepharospasm
|
0.00%
0/89
|
2.0%
2/102
|
0.00%
0/114
|
|
Eye disorders
Cataract
|
9.0%
8/89
|
14.7%
15/102
|
14.9%
17/114
|
|
Eye disorders
Cataract cortical
|
3.4%
3/89
|
2.9%
3/102
|
3.5%
4/114
|
|
Eye disorders
Cataract nuclear
|
0.00%
0/89
|
4.9%
5/102
|
5.3%
6/114
|
|
Eye disorders
Cataract subcapsular
|
7.9%
7/89
|
7.8%
8/102
|
4.4%
5/114
|
|
Eye disorders
Chalazion
|
0.00%
0/89
|
2.0%
2/102
|
0.88%
1/114
|
|
Eye disorders
Chemical eye injury
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Eye disorders
Chorioretinal disorder
|
0.00%
0/89
|
0.98%
1/102
|
0.88%
1/114
|
|
Eye disorders
Choroidal detachment
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Eye disorders
Choroiditis
|
2.2%
2/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Eye disorders
Colour blindness acquired
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Eye disorders
Conjunctival cyst
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Eye disorders
Conjunctival haemorrhage
|
11.2%
10/89
|
15.7%
16/102
|
7.9%
9/114
|
|
Eye disorders
Conjunctival hyperaemia
|
1.1%
1/89
|
0.00%
0/102
|
1.8%
2/114
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/89
|
2.0%
2/102
|
1.8%
2/114
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/89
|
0.98%
1/102
|
0.88%
1/114
|
|
Eye disorders
Conjunctivitis viral
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Eye disorders
Corneal abrasion
|
3.4%
3/89
|
0.98%
1/102
|
1.8%
2/114
|
|
Eye disorders
Corneal defect
|
1.1%
1/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Eye disorders
Corneal disorder
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Eye disorders
Corneal epithelium defect
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Eye disorders
Corneal erosion
|
1.1%
1/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Eye disorders
Corneal oedema
|
2.2%
2/89
|
2.0%
2/102
|
4.4%
5/114
|
|
Eye disorders
Corneal pigmentation
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Eye disorders
Corneal scar
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Eye disorders
Cystoid macular oedema
|
1.1%
1/89
|
2.0%
2/102
|
1.8%
2/114
|
|
Eye disorders
Diabetic retinal oedema
|
10.1%
9/89
|
5.9%
6/102
|
7.0%
8/114
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/89
|
3.9%
4/102
|
4.4%
5/114
|
|
Eye disorders
Diplopia
|
5.6%
5/89
|
2.0%
2/102
|
0.00%
0/114
|
|
Eye disorders
Dry eye
|
13.5%
12/89
|
9.8%
10/102
|
7.0%
8/114
|
|
Eye disorders
Episcleritis
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Eye disorders
Eye discharge
|
0.00%
0/89
|
2.9%
3/102
|
0.00%
0/114
|
|
Eye disorders
Eye infection
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Eye disorders
Eye irritation
|
9.0%
8/89
|
8.8%
9/102
|
2.6%
3/114
|
|
Eye disorders
Eye pain
|
24.7%
22/89
|
13.7%
14/102
|
18.4%
21/114
|
|
Eye disorders
Eye penetration
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Eye disorders
Eyelid disorder
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Eye disorders
Eyelid oedema
|
3.4%
3/89
|
2.9%
3/102
|
2.6%
3/114
|
|
Eye disorders
Eyelid ptosis
|
1.1%
1/89
|
2.0%
2/102
|
0.00%
0/114
|
|
Eye disorders
Foreign body sensation in eyes
|
1.1%
1/89
|
0.98%
1/102
|
3.5%
4/114
|
|
Eye disorders
Giant papillary conjunctivitis
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Eye disorders
Glare
|
1.1%
1/89
|
3.9%
4/102
|
0.00%
0/114
|
|
Eye disorders
Glaucoma
|
7.9%
7/89
|
3.9%
4/102
|
2.6%
3/114
|
|
Eye disorders
Halo vision
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Eye disorders
Hyphaema
|
3.4%
3/89
|
2.0%
2/102
|
0.88%
1/114
|
|
Eye disorders
Hypotony of eye
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Eye disorders
Iris adhesions
|
1.1%
1/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Eye disorders
Iris neovascularisation
|
3.4%
3/89
|
2.9%
3/102
|
1.8%
2/114
|
|
Eye disorders
Iritis
|
1.1%
1/89
|
0.00%
0/102
|
2.6%
3/114
|
|
Eye disorders
Keratitis
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Eye disorders
Keratopathy
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Eye disorders
Lacrimation increased
|
6.7%
6/89
|
2.9%
3/102
|
7.9%
9/114
|
|
Eye disorders
Lenticular pigmentation
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Eye disorders
Macular degeneration
|
1.1%
1/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Eye disorders
Macular fibrosis
|
14.6%
13/89
|
9.8%
10/102
|
7.9%
9/114
|
|
Eye disorders
Macular hole
|
0.00%
0/89
|
0.00%
0/102
|
1.8%
2/114
|
|
Eye disorders
Macular ischaemia
|
5.6%
5/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Eye disorders
Macular oedema
|
2.2%
2/89
|
4.9%
5/102
|
6.1%
7/114
|
|
Eye disorders
Metamorphopsia
|
5.6%
5/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Eye disorders
Ocular discomfort
|
2.2%
2/89
|
3.9%
4/102
|
3.5%
4/114
|
|
Eye disorders
Ocular hyperaemia
|
4.5%
4/89
|
0.98%
1/102
|
6.1%
7/114
|
|
Eye disorders
Ocular hypertension
|
2.2%
2/89
|
0.98%
1/102
|
2.6%
3/114
|
|
Eye disorders
Optic atrophy
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Eye disorders
Optic nerve cupping
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Eye disorders
Photophobia
|
7.9%
7/89
|
4.9%
5/102
|
2.6%
3/114
|
|
Eye disorders
Photopsia
|
11.2%
10/89
|
6.9%
7/102
|
4.4%
5/114
|
|
Eye disorders
Posterior capsule opacification
|
1.1%
1/89
|
3.9%
4/102
|
1.8%
2/114
|
|
Eye disorders
Punctate keratitis
|
2.2%
2/89
|
2.0%
2/102
|
3.5%
4/114
|
|
Eye disorders
Pupillary block
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Eye disorders
Pupillary reflex impaired
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Eye disorders
Retinal aneurysm
|
2.2%
2/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Eye disorders
Retinal artery embolism
|
0.00%
0/89
|
2.0%
2/102
|
0.00%
0/114
|
|
Eye disorders
Retinal artery occlusion
|
0.00%
0/89
|
0.98%
1/102
|
0.88%
1/114
|
|
Eye disorders
Retinal detachment
|
13.5%
12/89
|
12.7%
13/102
|
16.7%
19/114
|
|
Eye disorders
Retinal disorder
|
1.1%
1/89
|
2.0%
2/102
|
0.00%
0/114
|
|
Eye disorders
Retinal exudates
|
4.5%
4/89
|
7.8%
8/102
|
0.00%
0/114
|
|
Eye disorders
Retinal haemorrhage
|
11.2%
10/89
|
11.8%
12/102
|
7.0%
8/114
|
|
Eye disorders
Retinal ischaemia
|
0.00%
0/89
|
2.0%
2/102
|
1.8%
2/114
|
|
Eye disorders
Retinal neovascularisation
|
10.1%
9/89
|
14.7%
15/102
|
12.3%
14/114
|
|
Eye disorders
Retinal oedema
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Eye disorders
Retinal tear
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Eye disorders
Retinal vascular disorder
|
1.1%
1/89
|
2.0%
2/102
|
0.00%
0/114
|
|
Eye disorders
Retinopathy hypertensive
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Eye disorders
Scleritis
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Eye disorders
Vision blurred
|
37.1%
33/89
|
24.5%
25/102
|
22.8%
26/114
|
|
Eye disorders
Visual acuity reduced
|
19.1%
17/89
|
19.6%
20/102
|
17.5%
20/114
|
|
Eye disorders
Visual field defect
|
1.1%
1/89
|
0.98%
1/102
|
1.8%
2/114
|
|
Eye disorders
Visual impairment
|
10.1%
9/89
|
7.8%
8/102
|
3.5%
4/114
|
|
Eye disorders
Vitreal cells
|
1.1%
1/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Eye disorders
Vitreous adhesions
|
3.4%
3/89
|
2.9%
3/102
|
0.00%
0/114
|
|
Eye disorders
Vitreous detachment
|
6.7%
6/89
|
3.9%
4/102
|
7.9%
9/114
|
|
Eye disorders
Vitreous disorder
|
2.2%
2/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Eye disorders
Vitreous floaters
|
42.7%
38/89
|
31.4%
32/102
|
30.7%
35/114
|
|
Eye disorders
Vitreous haemorrhage
|
41.6%
37/89
|
45.1%
46/102
|
43.0%
49/114
|
|
Eye disorders
Vitreous opacities
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/89
|
4.9%
5/102
|
0.00%
0/114
|
|
Gastrointestinal disorders
Abdominal pain
|
4.5%
4/89
|
0.00%
0/102
|
2.6%
3/114
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.4%
3/89
|
2.0%
2/102
|
0.88%
1/114
|
|
Gastrointestinal disorders
Colitis ischaemic
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Gastrointestinal disorders
Colon cancer
|
1.1%
1/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Gastrointestinal disorders
Constipation
|
1.1%
1/89
|
2.0%
2/102
|
0.88%
1/114
|
|
Gastrointestinal disorders
Dental caries
|
1.1%
1/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Gastrointestinal disorders
Diabetic gastroparesis
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Gastrointestinal disorders
Diarrhoea
|
3.4%
3/89
|
0.98%
1/102
|
2.6%
3/114
|
|
Gastrointestinal disorders
Dyspepsia
|
2.2%
2/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Gastrointestinal disorders
Gastroenteritis
|
1.1%
1/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Gastrointestinal disorders
Gastroenteritis viral
|
3.4%
3/89
|
2.9%
3/102
|
1.8%
2/114
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.2%
2/89
|
5.9%
6/102
|
1.8%
2/114
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/89
|
0.98%
1/102
|
0.88%
1/114
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/89
|
0.00%
0/102
|
1.8%
2/114
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Gastrointestinal disorders
Lactose intolerance
|
0.00%
0/89
|
0.00%
0/102
|
1.8%
2/114
|
|
Gastrointestinal disorders
Nausea
|
7.9%
7/89
|
8.8%
9/102
|
5.3%
6/114
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Gastrointestinal disorders
Pancreatitis
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Gastrointestinal disorders
Tooth abscess
|
2.2%
2/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Gastrointestinal disorders
Tooth infection
|
1.1%
1/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Gastrointestinal disorders
Toothache
|
2.2%
2/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Gastrointestinal disorders
Vomiting
|
4.5%
4/89
|
4.9%
5/102
|
1.8%
2/114
|
|
General disorders
Chest discomfort
|
1.1%
1/89
|
0.00%
0/102
|
0.88%
1/114
|
|
General disorders
Chest pain
|
3.4%
3/89
|
2.9%
3/102
|
1.8%
2/114
|
|
General disorders
Chills
|
0.00%
0/89
|
0.98%
1/102
|
0.88%
1/114
|
|
General disorders
Device related infection
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
General disorders
Facial pain
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
General disorders
Fatigue
|
2.2%
2/89
|
0.98%
1/102
|
0.88%
1/114
|
|
General disorders
Flank pain
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
General disorders
Injection site irritation
|
0.00%
0/89
|
0.98%
1/102
|
0.88%
1/114
|
|
General disorders
Local swelling
|
2.2%
2/89
|
0.00%
0/102
|
0.00%
0/114
|
|
General disorders
Oedema peripheral
|
5.6%
5/89
|
3.9%
4/102
|
5.3%
6/114
|
|
General disorders
Pain
|
1.1%
1/89
|
2.0%
2/102
|
2.6%
3/114
|
|
General disorders
Pyrexia
|
1.1%
1/89
|
2.0%
2/102
|
0.00%
0/114
|
|
General disorders
Swelling
|
2.2%
2/89
|
0.98%
1/102
|
0.88%
1/114
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/89
|
0.98%
1/102
|
0.88%
1/114
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/89
|
0.00%
0/102
|
1.8%
2/114
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Surgical and medical procedures
Dental implantation
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/89
|
0.98%
1/102
|
0.88%
1/114
|
|
Immune system disorders
Seasonal allergy
|
5.6%
5/89
|
3.9%
4/102
|
4.4%
5/114
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.1%
1/89
|
0.98%
1/102
|
0.88%
1/114
|
|
Infections and infestations
Abscess
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Infections and infestations
Bronchopneumonia
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Infections and infestations
Candidiasis
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Infections and infestations
Fungal infection
|
0.00%
0/89
|
2.0%
2/102
|
0.00%
0/114
|
|
Infections and infestations
Gingival infection
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Infections and infestations
Helicobacter infection
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Infections and infestations
Infection
|
0.00%
0/89
|
2.9%
3/102
|
1.8%
2/114
|
|
Infections and infestations
Influenza
|
7.9%
7/89
|
10.8%
11/102
|
6.1%
7/114
|
|
Infections and infestations
Latent tuberculosis
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Infections and infestations
Localised infection
|
0.00%
0/89
|
4.9%
5/102
|
0.00%
0/114
|
|
Infections and infestations
Onychomycosis
|
2.2%
2/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Infections and infestations
Respiratory tract infection fungal
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Infections and infestations
Staphylococcal infection
|
1.1%
1/89
|
0.98%
1/102
|
0.88%
1/114
|
|
Injury, poisoning and procedural complications
Animal scratch
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
1.1%
1/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Injury, poisoning and procedural complications
Burns second degree
|
1.1%
1/89
|
0.98%
1/102
|
0.88%
1/114
|
|
Injury, poisoning and procedural complications
Fall
|
3.4%
3/89
|
2.0%
2/102
|
2.6%
3/114
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Injury, poisoning and procedural complications
Wound
|
2.2%
2/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Investigations
Biopsy skin
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Investigations
Blood creatinine abnormal
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Investigations
Blood glucose decreased
|
2.2%
2/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Investigations
Blood glucose increased
|
2.2%
2/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Investigations
Blood testosterone decreased
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Investigations
Cardiac murmur
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Investigations
Glycosylated haemoglobin increased
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Investigations
Intraocular pressure increased
|
6.7%
6/89
|
3.9%
4/102
|
3.5%
4/114
|
|
Investigations
Laboratory test abnormal
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Investigations
Low density lipoprotein increased
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Investigations
Red blood cell count decreased
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Investigations
Troponin increased
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/89
|
0.98%
1/102
|
0.88%
1/114
|
|
Metabolism and nutrition disorders
Fluid overload
|
3.4%
3/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/89
|
0.98%
1/102
|
0.88%
1/114
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
5.6%
5/89
|
3.9%
4/102
|
5.3%
6/114
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.2%
2/89
|
2.9%
3/102
|
0.00%
0/114
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
1.1%
1/89
|
2.0%
2/102
|
1.8%
2/114
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
4.5%
4/89
|
0.98%
1/102
|
0.88%
1/114
|
|
Musculoskeletal and connective tissue disorders
Ankle fracture
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.2%
2/89
|
2.0%
2/102
|
1.8%
2/114
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.2%
2/89
|
3.9%
4/102
|
4.4%
5/114
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Musculoskeletal and connective tissue disorders
Foot fracture
|
2.2%
2/89
|
2.9%
3/102
|
1.8%
2/114
|
|
Musculoskeletal and connective tissue disorders
Gout
|
1.1%
1/89
|
0.98%
1/102
|
0.88%
1/114
|
|
Musculoskeletal and connective tissue disorders
Hand fracture
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Musculoskeletal and connective tissue disorders
Ligament sprain
|
0.00%
0/89
|
4.9%
5/102
|
2.6%
3/114
|
|
Musculoskeletal and connective tissue disorders
Lower limb fracture
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Musculoskeletal and connective tissue disorders
Medial tibial stress syndrome
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Musculoskeletal and connective tissue disorders
Meniscus injury
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Musculoskeletal and connective tissue disorders
Multiple fractures
|
2.2%
2/89
|
2.0%
2/102
|
0.88%
1/114
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.1%
1/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Musculoskeletal and connective tissue disorders
Muscle strain
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/89
|
2.9%
3/102
|
1.8%
2/114
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.1%
1/89
|
0.98%
1/102
|
0.88%
1/114
|
|
Musculoskeletal and connective tissue disorders
Neuropathic arthropathy
|
0.00%
0/89
|
0.98%
1/102
|
0.88%
1/114
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
3.4%
3/89
|
0.98%
1/102
|
3.5%
4/114
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.2%
2/89
|
5.9%
6/102
|
1.8%
2/114
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.00%
0/89
|
0.98%
1/102
|
0.88%
1/114
|
|
Musculoskeletal and connective tissue disorders
Wrist fracture
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Abdominal neoplasm
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acoustic neuroma
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Nervous system disorders
Balance disorder
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Nervous system disorders
Concussion
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Nervous system disorders
Dementia
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Nervous system disorders
Diabetic neuropathy
|
3.4%
3/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Nervous system disorders
Dizziness
|
6.7%
6/89
|
4.9%
5/102
|
3.5%
4/114
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Nervous system disorders
Encephalopathy
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Nervous system disorders
Headache
|
16.9%
15/89
|
9.8%
10/102
|
15.8%
18/114
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Nervous system disorders
Hypoaesthesia
|
2.2%
2/89
|
0.00%
0/102
|
1.8%
2/114
|
|
Nervous system disorders
IIIrd nerve paralysis
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Nervous system disorders
IVth nerve paralysis
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Nervous system disorders
Migraine
|
1.1%
1/89
|
2.0%
2/102
|
0.88%
1/114
|
|
Nervous system disorders
Nerve injury
|
1.1%
1/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Nervous system disorders
Neuropathy peripheral
|
1.1%
1/89
|
2.0%
2/102
|
0.00%
0/114
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Nervous system disorders
Presyncope
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Nervous system disorders
Sciatica
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Nervous system disorders
Syncope
|
1.1%
1/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Nervous system disorders
Temporal arteritis
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Nervous system disorders
Vertigo
|
0.00%
0/89
|
2.0%
2/102
|
0.88%
1/114
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/89
|
2.0%
2/102
|
2.6%
3/114
|
|
Psychiatric disorders
Depression
|
2.2%
2/89
|
0.98%
1/102
|
7.0%
8/114
|
|
Psychiatric disorders
Drug abuse
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/89
|
2.0%
2/102
|
1.8%
2/114
|
|
Psychiatric disorders
Stress
|
0.00%
0/89
|
0.98%
1/102
|
0.88%
1/114
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/89
|
2.0%
2/102
|
0.00%
0/114
|
|
Renal and urinary disorders
Bladder cancer
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Renal and urinary disorders
Cystitis
|
1.1%
1/89
|
0.98%
1/102
|
0.88%
1/114
|
|
Renal and urinary disorders
Dysuria
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Renal and urinary disorders
Hydronephrosis
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Renal and urinary disorders
Kidney infection
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/89
|
2.0%
2/102
|
0.88%
1/114
|
|
Renal and urinary disorders
Nephropathy
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Renal and urinary disorders
Proteinuria
|
1.1%
1/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Renal and urinary disorders
Pyelonephritis
|
1.1%
1/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Renal and urinary disorders
Renal failure
|
5.6%
5/89
|
2.0%
2/102
|
2.6%
3/114
|
|
Renal and urinary disorders
Renal failure acute
|
1.1%
1/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Renal and urinary disorders
Renal failure chronic
|
3.4%
3/89
|
0.00%
0/102
|
4.4%
5/114
|
|
Renal and urinary disorders
Renal impairment
|
1.1%
1/89
|
0.98%
1/102
|
0.88%
1/114
|
|
Renal and urinary disorders
Renal osteodystrophy
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Renal and urinary disorders
Urinary tract disorder
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Renal and urinary disorders
Urinary tract infection
|
4.5%
4/89
|
5.9%
6/102
|
3.5%
4/114
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/89
|
0.98%
1/102
|
0.88%
1/114
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Reproductive system and breast disorders
Prostate cancer
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Reproductive system and breast disorders
Prostatitis
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Reproductive system and breast disorders
Testicular swelling
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Reproductive system and breast disorders
Uterine leiomyoma
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/89
|
0.00%
0/102
|
1.8%
2/114
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
3.4%
3/89
|
4.9%
5/102
|
1.8%
2/114
|
|
Respiratory, thoracic and mediastinal disorders
Chronic sinusitis
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.0%
8/89
|
5.9%
6/102
|
4.4%
5/114
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.7%
6/89
|
2.9%
3/102
|
1.8%
2/114
|
|
Respiratory, thoracic and mediastinal disorders
Lung neoplasm
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.4%
3/89
|
0.98%
1/102
|
2.6%
3/114
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
16.9%
15/89
|
16.7%
17/102
|
8.8%
10/114
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.6%
5/89
|
4.9%
5/102
|
0.00%
0/114
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis streptococcal
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/89
|
0.98%
1/102
|
1.8%
2/114
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
1.1%
1/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
1.1%
1/89
|
0.98%
1/102
|
0.88%
1/114
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract infection
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
2.2%
2/89
|
9.8%
10/102
|
6.1%
7/114
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/89
|
0.98%
1/102
|
0.88%
1/114
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
2.2%
2/89
|
3.9%
4/102
|
1.8%
2/114
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Skin and subcutaneous tissue disorders
Basal cell carcinoma
|
1.1%
1/89
|
0.00%
0/102
|
1.8%
2/114
|
|
Skin and subcutaneous tissue disorders
Blister
|
2.2%
2/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
3.4%
3/89
|
3.9%
4/102
|
0.88%
1/114
|
|
Skin and subcutaneous tissue disorders
Contusion
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
1.1%
1/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
3.4%
3/89
|
0.98%
1/102
|
1.8%
2/114
|
|
Skin and subcutaneous tissue disorders
Diabetic ulcer
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Skin and subcutaneous tissue disorders
Excoriation
|
1.1%
1/89
|
2.0%
2/102
|
0.00%
0/114
|
|
Skin and subcutaneous tissue disorders
Furuncle
|
1.1%
1/89
|
0.98%
1/102
|
0.88%
1/114
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
2.2%
2/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
1.1%
1/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Skin and subcutaneous tissue disorders
Onychomycosis
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/89
|
2.0%
2/102
|
0.00%
0/114
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.1%
1/89
|
2.0%
2/102
|
2.6%
3/114
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Skin and subcutaneous tissue disorders
Skin infection
|
0.00%
0/89
|
2.0%
2/102
|
0.00%
0/114
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Skin and subcutaneous tissue disorders
Skin papilloma
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
1.1%
1/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Social circumstances
Menopause
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Surgical and medical procedures
Abdominal panniculectomy
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Surgical and medical procedures
Benign tumour excision
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Surgical and medical procedures
Cataract operation
|
0.00%
0/89
|
3.9%
4/102
|
1.8%
2/114
|
|
Surgical and medical procedures
Cholecystectomy
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Surgical and medical procedures
Gastric banding
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Surgical and medical procedures
Glaucoma surgery
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Surgical and medical procedures
Retinal laser coagulation
|
1.1%
1/89
|
2.9%
3/102
|
0.88%
1/114
|
|
Surgical and medical procedures
Skin lesion excision
|
0.00%
0/89
|
0.98%
1/102
|
0.00%
0/114
|
|
Surgical and medical procedures
Surgery
|
0.00%
0/89
|
2.9%
3/102
|
0.88%
1/114
|
|
Surgical and medical procedures
Tooth extraction
|
1.1%
1/89
|
2.9%
3/102
|
0.00%
0/114
|
|
Surgical and medical procedures
Vitrectomy
|
0.00%
0/89
|
5.9%
6/102
|
7.0%
8/114
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Vascular disorders
Arteriovenous fistula
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Vascular disorders
Cerebrovascular accident
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Vascular disorders
Hypertension
|
14.6%
13/89
|
23.5%
24/102
|
15.8%
18/114
|
|
Vascular disorders
Hypotension
|
2.2%
2/89
|
0.98%
1/102
|
0.88%
1/114
|
|
Vascular disorders
Iliac artery occlusion
|
0.00%
0/89
|
0.00%
0/102
|
0.88%
1/114
|
|
Vascular disorders
Peripheral artery stenosis
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Vascular disorders
Transient ischaemic attack
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
|
Vascular disorders
Varicose vein
|
1.1%
1/89
|
0.00%
0/102
|
0.00%
0/114
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Trial results can not be discussed until they have been made available to the public.
- Publication restrictions are in place
Restriction type: OTHER