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Trial record 29 of 32 for:    retina associates of kentucky

Prompt Panretinal Photocoagulation Versus Ranibizumab+Deferred Panretinal Photocoagulation for Proliferative Diabetic Retinopathy (Protocol S)

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ClinicalTrials.gov Identifier: NCT01489189
Recruitment Status : Completed
First Posted : December 9, 2011
Results First Posted : June 1, 2016
Last Update Posted : July 10, 2018
Sponsor:
Collaborators:
National Eye Institute (NEI)
Genentech, Inc.
Information provided by (Responsible Party):
Jaeb Center for Health Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Proliferative Diabetic Retinopathy
Interventions Other: Prompt Panretinal Photocoagulation
Drug: 0.5-mg Ranibizumab
Other: Deferred panretinal photocoagulation
Enrollment 305
Recruitment Details

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).

Pre-assignment Details  
Arm/Group Title Anti-VEGF+Deferred PRP Prompt PRP
Hide Arm/Group Description

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.

Panretinal Photocoagulation (PRP). PRP alone.

Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days).

Period Title: Overall Study
Started 191 [1] 203 [1]
Completed 160 [1] 168 [1]
Not Completed 31 35
Reason Not Completed
Withdrawal by Subject             20             23
Death             10             8
Missed Visit             1             4
[1]
Number of Eyes
Arm/Group Title Anti-VEGF+Deferred PRP Prompt PRP Total
Hide Arm/Group Description

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.

PRP= Panretinal Photocoagulation. PRP alone.

Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days).

Total of all reporting groups
Overall Number of Baseline Participants 191 203 394
Hide Baseline Analysis Population Description
Units in Eyes
Age, Customized  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 191 participants 203 participants 394 participants
52
(44 to 59)
51
(44 to 59)
51
(44 to 59)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Eyes
Number Analyzed 191 participants 203 participants 394 participants
Female 83 92 175
Male 108 111 219
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Eyes
Number Analyzed 191 participants 203 participants 394 participants
White 100 101 201
Hispanic 48 51 99
Black/African American 38 43 81
Asian 2 3 5
American Indian/Alaskan Native 1 0 1
More than 1 race 0 2 2
Unknown/not reported 2 3 5
Number of study eyes  
Measure Type: Number
Unit of measure:  Eyes
Number Analyzed 191 participants 203 participants 394 participants
One 102 114 216
Two (one in each group) 89 89 178
Diabetes Type  
Measure Type: Number
Unit of measure:  Eyes
Number Analyzed 191 participants 203 participants 394 participants
Type 1 43 41 84
Type 2 140 155 295
Uncertain 8 7 15
Duration of Diabetes  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 191 participants 203 participants 394 participants
18
(12 to 24)
17
(11 to 23)
18
(11 to 24)
Hemoglobin A1c   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Percent
Number Analyzed 191 participants 203 participants 394 participants
8.6
(7.5 to 10.4)
8.9
(7.5 to 10.4)
8.7
(7.5 to 10.4)
[1]
Measure Description: Hemoglobin A1c data were missing for 7 in the anti-VEGF+Deferred PRP group and 5 in the prompt PRP group.
Prior Myocardial Infarction  
Measure Type: Number
Unit of measure:  Eyes
Number Analyzed 191 participants 203 participants 394 participants
3 4 7
Prior Stroke  
Measure Type: Number
Unit of measure:  Eyes
Number Analyzed 191 participants 203 participants 394 participants
4 3 7
Arterial Blood Pressure  
Median (Inter-Quartile Range)
Unit of measure:  mmHg
Number Analyzed 191 participants 203 participants 394 participants
99
(88 to 108)
99
(88 to 107)
99
(88 to 108)
Visual Acuity   [1] 
Mean (Standard Deviation)
Unit of measure:  Letters
Number Analyzed 191 participants 203 participants 394 participants
75  (12.8) 75.2  (12.5) 75.1  (12.6)
[1]
Measure Description: 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 (ETDRS) method. Best value on the scale 97, worst 0.
Optical Coherence Tomography Central Subfield Thickness   [1] 
Median (Inter-Quartile Range)
Unit of measure:  µm
Number Analyzed 191 participants 203 participants 394 participants
223
(196 to 271)
230
(203 to 265)
229
(199 to 266)
[1]
Measure Description:

OCT central subfield thickness measurements were missing for 2 in the anti-VEGF+deferred PRP group and 2 in the prompt PRP group.

Assessments from OCT machines other than Zeiss Stratus were converted to equivalent on Zeiss Stratus machines.

Presence of Center-Involved Diabetic Macular Edema with Visual Acuity Impairment   [1] 
Measure Type: Number
Unit of measure:  Eyes
Number Analyzed 191 participants 203 participants 394 participants
42 46 88
[1]
Measure Description: OCT central subfield thickness measurements were missing for 2 in the anti-VEGF+deferred PRP group and 2 in the Prompt PRP group.
Presence of Center-Involved Diabetic Macular Edema Regardless of Visual Acuity   [1] 
Measure Type: Number
Unit of measure:  Eyes
Number Analyzed 191 participants 203 participants 394 participants
55 62 117
[1]
Measure Description: OCT central subfield thickness measurements were missing for 2 in the anti-VEGF+deferred PRP group and 2 in the Prompt PRP group.
Neovascularization on Clinical Examination  
Measure Type: Number
Unit of measure:  Eyes
Number Analyzed 191 participants 203 participants 394 participants
Of the disc 96 103 199
Elsewhere 166 174 340
Phakic Lens Status on Clinical Exam  
Measure Type: Number
Unit of measure:  Eyes
Number Analyzed 191 participants 203 participants 394 participants
170 187 357
Diabetic Retinopathy Severity   [1] 
Measure Type: Number
Unit of measure:  Eyes
Number Analyzed 191 participants 203 participants 394 participants
Microaneurysms only (level 20) 0 1 1
Mild NPDR (level 35) 6 4 10
Moderate NPDR (level 43) 2 5 7
Moderately severe NPDR (level 47) 10 15 25
Severe NPDR (level 53) 1 1 2
Prior PRP without active PDR (level 60) 0 1 1
Mild PDR (level 61) 30 31 61
Moderate PDR (level 65) 68 67 135
High-risk PDR (levels 71 and 75) 69 73 142
Advanced PDR, macular center attached (level 81) 2 0 2
Advanced PDR, macular center detached (level 85) 1 1 2
[1]
Measure Description: Diabetic retinopathy level data were missing for 2 in the anti-VEGF+deferred PRP group and 4 in the prompt PRP group. Proliferative diabetic retinopathy (PDR) could not be identified by the reading center in 46 eyes (12%) but was subsequently confirmed by other imaging modes in 29 (63%) of the 46 eyes.
Prior treatment for diabetic macular edema (DME)  
Measure Type: Number
Unit of measure:  Eyes
Number Analyzed 191 participants 203 participants 394 participants
43 36 79
Prior focal/grid laser treatment for DME  
Measure Type: Number
Unit of measure:  Eyes
Number Analyzed 191 participants 203 participants 394 participants
30 29 59
Prior anti-VEGF treatment for DME  
Measure Type: Number
Unit of measure:  Eyes
Number Analyzed 191 participants 203 participants 394 participants
21 13 34
1.Primary Outcome
Title Mean Change in Visual Acuity From Baseline
Hide Description 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.
Time Frame 2-years
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that completed the 2-year visit.
Arm/Group Title Anti-VEGF+Deferred PRP Prompt PRP
Hide Arm/Group Description:

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.

PRP= Panretinal Photocoagulation. PRP alone.

Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days).

Overall Number of Participants Analyzed 160 168
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
160 168
Mean (95% Confidence Interval)
Unit of Measure: letters
2.8
(0.4 to 5.2)
0.2
(-1.9 to 2.3)
2.Secondary Outcome
Title Mean Visual Acuity
Hide Description 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.
Time Frame 2-years
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that completed the 2-year visit.
Arm/Group Title Anti-VEGF+Deferred PRP Prompt PRP
Hide Arm/Group Description:

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.

PRP= Panretinal Photocoagulation. PRP alone.

Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days).

Overall Number of Participants Analyzed 160 168
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
160 168
Mean (Standard Deviation)
Unit of Measure: letters
78.7  (16.3) 76.2  (14.1)
3.Secondary Outcome
Title Number of Eyes With Greater Than or Equal to 10 Letter Vision Gain
Hide Description [Not Specified]
Time Frame 2-years
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Anti-VEGF+Deferred PRP Prompt PRP
Hide Arm/Group Description:

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.

PRP= Panretinal Photocoagulation. PRP alone.

Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days).

Overall Number of Participants Analyzed 81 86
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
81 86
Measure Type: Number
Unit of Measure: eyes
35 31
4.Secondary Outcome
Title Humphrey Visual Field Test Cumulative Score Change From Baseline
Hide Description 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.
Time Frame 2-years
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Anti-VEGF+Deferred PRP Prompt PRP
Hide Arm/Group Description:

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.

PRP= Panretinal Photocoagulation. PRP alone.

Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days).

Overall Number of Participants Analyzed 58 57
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
58 57
Median (Inter-Quartile Range)
Unit of Measure: decibels
-25
(-232 to 223)
-379
(-723 to -75)
5.Secondary Outcome
Title Frequency of Vitrectomy
Hide Description [Not Specified]
Time Frame 2-years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anti-VEGF+Deferred PRP Prompt PRP
Hide Arm/Group Description:

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.

PRP= Panretinal Photocoagulation. PRP alone.

Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days).

Overall Number of Participants Analyzed 191 203
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
191 203
Measure Type: Number
Unit of Measure: eyes
8 30
6.Secondary Outcome
Title Mean Change in OCT Central Subfield Thickness From Baseline
Hide Description All baseline and 2-year optical coherence tomography (OCT) scans were evaluated by the OCT reading center.
Time Frame 2-years
Hide Outcome Measure Data
Hide Analysis Population Description
Eyes with optical coherence tomography (OCT) data at baseline and 2-years.
Arm/Group Title Anti-VEGF+Deferred PRP Prompt PRP
Hide Arm/Group Description:

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.

PRP= Panretinal Photocoagulation. PRP alone.

Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days).

Overall Number of Participants Analyzed 149 161
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
149 161
Mean (95% Confidence Interval)
Unit of Measure: µm
-47
(-61 to -33)
-3
(-15 to 9)
7.Secondary Outcome
Title Development of Central DME With Vision Impairment by 2-years
Hide Description [Not Specified]
Time Frame 2-years
Hide Outcome Measure Data
Hide Analysis Population Description
Excludes that did not have central DME with vision impairment (20/32 or worse) at baseline.
Arm/Group Title Anti-VEGF+Deferred PRP Prompt PRP
Hide Arm/Group Description:

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.

PRP= Panretinal Photocoagulation. PRP alone.

Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days).

Overall Number of Participants Analyzed 147 155
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
147 155
Measure Type: Number
Unit of Measure: eyes
15 42
8.Secondary Outcome
Title Number of Eyes With Vitreous Hemorrhage
Hide Description [Not Specified]
Time Frame 2-years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anti-VEGF+Deferred PRP Prompt PRP
Hide Arm/Group Description:

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.

PRP= Panretinal Photocoagulation. PRP alone.

Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days).

Overall Number of Participants Analyzed 191 203
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
191 203
Measure Type: Number
Unit of Measure: Eyes
52 69
9.Secondary Outcome
Title Number of Eyes Without Active or Regressed Neovascularization on Fundus Photography at 2-years
Hide Description [Not Specified]
Time Frame 2-years
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Anti-VEGF+Deferred PRP Prompt PRP
Hide Arm/Group Description:

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.

PRP= Panretinal Photocoagulation. PRP alone.

Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days).

Overall Number of Participants Analyzed 142 148
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
142 148
Measure Type: Number
Unit of Measure: eyes
49 44
10.Secondary Outcome
Title Number of Eyes With Greater Than or Equal to 10 Letter Vision Loss
Hide Description [Not Specified]
Time Frame 2-year
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that completed the 2-year visit.
Arm/Group Title Anti-VEGF+Deferred PRP Prompt PRP
Hide Arm/Group Description:

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.

PRP= Panretinal Photocoagulation. PRP alone.

Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days).

Overall Number of Participants Analyzed 160 168
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
160 168
Measure Type: Number
Unit of Measure: eyes
15 23
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bilateral Participants Anti-VEGF+Deferred PRP Prompt PRP
Hide Arm/Group Description Participants with one eye enrolled in each arm of the study.

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.

PRP= Panretinal Photocoagulation. PRP alone.

Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days).

All-Cause Mortality
Bilateral Participants Anti-VEGF+Deferred PRP Prompt PRP
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Bilateral Participants Anti-VEGF+Deferred PRP Prompt PRP
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   36/89 (40.45%)   50/102 (49.02%)   43/114 (37.72%) 
Blood and lymphatic system disorders       
Leukaemia * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Pancytopenia * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Cardiac disorders       
Atrial fibrillation * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Cardiac arrest * 1  0/89 (0.00%)  2/102 (1.96%)  0/114 (0.00%) 
Cardiac failure * 1  0/89 (0.00%)  1/102 (0.98%)  1/114 (0.88%) 
Cardiac failure congestive * 1  2/89 (2.25%)  6/102 (5.88%)  2/114 (1.75%) 
Cardiomyopathy * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Coronary artery disease * 1  2/89 (2.25%)  1/102 (0.98%)  1/114 (0.88%) 
Coronary artery restenosis * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Coronary artery stenosis * 1  1/89 (1.12%)  1/102 (0.98%)  0/114 (0.00%) 
Diastolic dysfunction * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Myocardial infarction * 1  3/89 (3.37%)  3/102 (2.94%)  2/114 (1.75%) 
Pericarditis * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Ear and labyrinth disorders       
Inner ear disorder * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Endocrine disorders       
Diabetes mellitus * 1  0/89 (0.00%)  2/102 (1.96%)  0/114 (0.00%) 
Diabetes mellitus inadequate control * 1  1/89 (1.12%)  2/102 (1.96%)  1/114 (0.88%) 
Diabetic ketoacidosis * 1  0/89 (0.00%)  4/102 (3.92%)  3/114 (2.63%) 
Hyperglycaemia * 1  2/89 (2.25%)  0/102 (0.00%)  0/114 (0.00%) 
Hypoglycaemia * 1  1/89 (1.12%)  1/102 (0.98%)  1/114 (0.88%) 
Eye disorders       
Angle closure glaucoma * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Endophthalmitis * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Ocular hypertension * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Visual acuity reduced * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Vitreous haemorrhage * 1  0/89 (0.00%)  1/102 (0.98%)  1/114 (0.88%) 
Gastrointestinal disorders       
Abdominal pain * 1  0/89 (0.00%)  2/102 (1.96%)  0/114 (0.00%) 
Diabetic gastroparesis * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Gastritis * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Gastroenteritis * 1  0/89 (0.00%)  1/102 (0.98%)  1/114 (0.88%) 
Gastroenteritis viral * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Impaired gastric emptying * 1  0/89 (0.00%)  0/102 (0.00%)  2/114 (1.75%) 
Pancreatitis * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Vomiting * 1  1/89 (1.12%)  1/102 (0.98%)  0/114 (0.00%) 
General disorders       
Chest pain * 1  2/89 (2.25%)  5/102 (4.90%)  3/114 (2.63%) 
Death * 1  1/89 (1.12%)  3/102 (2.94%)  2/114 (1.75%) 
Hernia * 1  1/89 (1.12%)  0/102 (0.00%)  1/114 (0.88%) 
Local swelling * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Oedema peripheral * 1  0/89 (0.00%)  1/102 (0.98%)  1/114 (0.88%) 
Pain * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Hepatobiliary disorders       
Cholecystitis acute * 1  1/89 (1.12%)  1/102 (0.98%)  0/114 (0.00%) 
Cholelithiasis * 1  0/89 (0.00%)  1/102 (0.98%)  1/114 (0.88%) 
Infections and infestations       
Abscess * 1  1/89 (1.12%)  1/102 (0.98%)  1/114 (0.88%) 
Beta haemolytic streptococcal infection * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Diverticulitis * 1  1/89 (1.12%)  2/102 (1.96%)  0/114 (0.00%) 
Gastroenteritis norovirus * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Infection * 1  0/89 (0.00%)  1/102 (0.98%)  1/114 (0.88%) 
Influenza * 1  1/89 (1.12%)  1/102 (0.98%)  1/114 (0.88%) 
Localised infection * 1  4/89 (4.49%)  3/102 (2.94%)  1/114 (0.88%) 
Postoperative wound infection * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Sepsis * 1  2/89 (2.25%)  1/102 (0.98%)  0/114 (0.00%) 
Injury, poisoning and procedural complications       
Wound * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Investigations       
Blood creatinine abnormal * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Blood glucose decreased * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Colonoscopy * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Metabolism and nutrition disorders       
Dehydration * 1  1/89 (1.12%)  1/102 (0.98%)  1/114 (0.88%) 
Fluid overload * 1  2/89 (2.25%)  2/102 (1.96%)  0/114 (0.00%) 
Hyperkalaemia * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Obesity * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Musculoskeletal and connective tissue disorders       
Ankle fracture * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Back pain * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Foot fracture * 1  0/89 (0.00%)  2/102 (1.96%)  1/114 (0.88%) 
Fractured coccyx * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Gout * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Multiple fractures * 1  0/89 (0.00%)  1/102 (0.98%)  1/114 (0.88%) 
Osteomyelitis * 1  2/89 (2.25%)  2/102 (1.96%)  1/114 (0.88%) 
Pain in extremity * 1  0/89 (0.00%)  0/102 (0.00%)  2/114 (1.75%) 
Temporomandibular joint syndrome * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Wrist fracture * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Myelodysplastic syndrome * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Nervous system disorders       
Autonomic nervous system imbalance * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Brain neoplasm * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Convulsion * 1  1/89 (1.12%)  1/102 (0.98%)  1/114 (0.88%) 
Encephalopathy * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Headache * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Syncope * 1  0/89 (0.00%)  3/102 (2.94%)  1/114 (0.88%) 
Tremor * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Vertigo * 1  0/89 (0.00%)  0/102 (0.00%)  2/114 (1.75%) 
Psychiatric disorders       
Anxiety * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Mental disorder * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Suicide attempt * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Renal and urinary disorders       
Cystitis * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Haematuria * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Nephrolithiasis * 1  2/89 (2.25%)  0/102 (0.00%)  0/114 (0.00%) 
Nephrotic Syndrome * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Pyelonephritis * 1  2/89 (2.25%)  1/102 (0.98%)  0/114 (0.00%) 
Renal failure * 1  1/89 (1.12%)  7/102 (6.86%)  2/114 (1.75%) 
Renal failure acute * 1  2/89 (2.25%)  2/102 (1.96%)  0/114 (0.00%) 
Renal failure chronic * 1  1/89 (1.12%)  4/102 (3.92%)  3/114 (2.63%) 
Renal impairment * 1  0/89 (0.00%)  3/102 (2.94%)  0/114 (0.00%) 
Urinary retention * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Urinary tract infection * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Acute respiratory failure * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Chronic obstructive pulmonary disease * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Cough * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Dyspnoea * 1  0/89 (0.00%)  2/102 (1.96%)  0/114 (0.00%) 
Hypoxia * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Pleural effusion * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Pneumonia * 1  4/89 (4.49%)  4/102 (3.92%)  2/114 (1.75%) 
Pulmonary embolism * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Pulmonary oedema * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Respiratory distress * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Respiratory tract congestion * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Respiratory tract oedema * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Skin and subcutaneous tissue disorders       
Cellulitis * 1  1/89 (1.12%)  2/102 (1.96%)  2/114 (1.75%) 
Diabetic foot * 1  2/89 (2.25%)  2/102 (1.96%)  0/114 (0.00%) 
Gangrene * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Herpes zoster * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Skin infection * 1  1/89 (1.12%)  1/102 (0.98%)  0/114 (0.00%) 
Skin ulcer * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Surgical and medical procedures       
Cardiac operation * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Coronary angioplasty * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Coronary artery bypass * 1  0/89 (0.00%)  1/102 (0.98%)  1/114 (0.88%) 
Knee operation * 1  0/89 (0.00%)  0/102 (0.00%)  2/114 (1.75%) 
Leg amputation * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Stent placement * 1  1/89 (1.12%)  1/102 (0.98%)  1/114 (0.88%) 
Surgery * 1  1/89 (1.12%)  1/102 (0.98%)  0/114 (0.00%) 
Toe amputation * 1  0/89 (0.00%)  3/102 (2.94%)  0/114 (0.00%) 
Tonsillectomy * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Vascular disorders       
Arteriosclerosis * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Carotid artery disease * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Cerebrovascular accident * 1  1/89 (1.12%)  2/102 (1.96%)  3/114 (2.63%) 
Embolism * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Hypertension * 2  1/89 (1.12%)  2/102 (1.96%)  3/114 (2.63%) 
Hypotension * 1  1/89 (1.12%)  1/102 (0.98%)  0/114 (0.00%) 
Ischaemic stroke * 1  0/89 (0.00%)  0/102 (0.00%)  2/114 (1.75%) 
Peripheral ischaemia * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Peripheral vascular disorder * 1  1/89 (1.12%)  1/102 (0.98%)  0/114 (0.00%) 
Thrombosis * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Transient ischaemic attack * 1  0/89 (0.00%)  2/102 (1.96%)  1/114 (0.88%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
2
Term from vocabulary, MedDRA\
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events .00001%
Bilateral Participants Anti-VEGF+Deferred PRP Prompt PRP
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   85/89 (95.51%)   96/102 (94.12%)   105/114 (92.11%) 
Blood and lymphatic system disorders       
Anaemia * 1  7/89 (7.87%)  9/102 (8.82%)  6/114 (5.26%) 
Anaemia of chronic disease * 1  2/89 (2.25%)  1/102 (0.98%)  0/114 (0.00%) 
Leukocytosis * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Lymphoedema * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Splenomegaly * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Cardiac disorders       
Angina pectoris * 1  0/89 (0.00%)  2/102 (1.96%)  0/114 (0.00%) 
Atrial flutter * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Cardiac failure * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Cardiac failure congestive * 1  2/89 (2.25%)  2/102 (1.96%)  0/114 (0.00%) 
Coronary artery disease * 1  2/89 (2.25%)  5/102 (4.90%)  1/114 (0.88%) 
Left ventricular dysfunction * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Ventricular hypokinesia * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Ear and labyrinth disorders       
Deafness * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Ear discomfort * 1  0/89 (0.00%)  1/102 (0.98%)  1/114 (0.88%) 
Ear infection * 1  1/89 (1.12%)  4/102 (3.92%)  2/114 (1.75%) 
Ear pain * 1  3/89 (3.37%)  2/102 (1.96%)  1/114 (0.88%) 
Eustachian tube dysfunction * 1  0/89 (0.00%)  1/102 (0.98%)  1/114 (0.88%) 
Middle ear effusion * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Otitis media * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Otitis media acute * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Tinnitus * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Endocrine disorders       
Cushing's syndrome * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Diabetes mellitus * 1  3/89 (3.37%)  3/102 (2.94%)  2/114 (1.75%) 
Diabetes mellitus inadequate control * 1  7/89 (7.87%)  5/102 (4.90%)  4/114 (3.51%) 
Diabetic ketoacidosis * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Hyperglycaemia * 1  3/89 (3.37%)  6/102 (5.88%)  3/114 (2.63%) 
Hyperthyroidism * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Hypoglycaemia * 1  1/89 (1.12%)  8/102 (7.84%)  0/114 (0.00%) 
Hypothyroidism * 1  3/89 (3.37%)  0/102 (0.00%)  0/114 (0.00%) 
Thyroid neoplasm * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Eye disorders       
Abnormal sensation in eye * 1  1/89 (1.12%)  0/102 (0.00%)  1/114 (0.88%) 
Accommodation disorder * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Altered visual depth perception * 1  0/89 (0.00%)  0/102 (0.00%)  2/114 (1.75%) 
Angle closure glaucoma * 1  2/89 (2.25%)  0/102 (0.00%)  0/114 (0.00%) 
Anterior chamber cell * 1  3/89 (3.37%)  1/102 (0.98%)  1/114 (0.88%) 
Anterior chamber flare * 1  0/89 (0.00%)  0/102 (0.00%)  2/114 (1.75%) 
Aphakia * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Asthenopia * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Blepharal papilloma * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Blepharitis * 1  3/89 (3.37%)  2/102 (1.96%)  0/114 (0.00%) 
Blepharospasm * 1  0/89 (0.00%)  2/102 (1.96%)  0/114 (0.00%) 
Cataract * 1  8/89 (8.99%)  15/102 (14.71%)  17/114 (14.91%) 
Cataract cortical * 1  3/89 (3.37%)  3/102 (2.94%)  4/114 (3.51%) 
Cataract nuclear * 1  0/89 (0.00%)  5/102 (4.90%)  6/114 (5.26%) 
Cataract subcapsular * 1  7/89 (7.87%)  8/102 (7.84%)  5/114 (4.39%) 
Chalazion * 1  0/89 (0.00%)  2/102 (1.96%)  1/114 (0.88%) 
Chemical eye injury * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Chorioretinal disorder * 1  0/89 (0.00%)  1/102 (0.98%)  1/114 (0.88%) 
Choroidal detachment * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Choroiditis * 1  2/89 (2.25%)  0/102 (0.00%)  0/114 (0.00%) 
Colour blindness acquired * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Conjunctival cyst * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Conjunctival haemorrhage * 1  10/89 (11.24%)  16/102 (15.69%)  9/114 (7.89%) 
Conjunctival hyperaemia * 1  1/89 (1.12%)  0/102 (0.00%)  2/114 (1.75%) 
Conjunctivitis * 1  0/89 (0.00%)  2/102 (1.96%)  2/114 (1.75%) 
Conjunctivitis allergic * 1  0/89 (0.00%)  1/102 (0.98%)  1/114 (0.88%) 
Conjunctivitis viral * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Corneal abrasion * 1  3/89 (3.37%)  1/102 (0.98%)  2/114 (1.75%) 
Corneal defect * 1  1/89 (1.12%)  0/102 (0.00%)  1/114 (0.88%) 
Corneal disorder * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Corneal epithelium defect * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Corneal erosion * 1  1/89 (1.12%)  1/102 (0.98%)  0/114 (0.00%) 
Corneal oedema * 1  2/89 (2.25%)  2/102 (1.96%)  5/114 (4.39%) 
Corneal pigmentation * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Corneal scar * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Cystoid macular oedema * 1  1/89 (1.12%)  2/102 (1.96%)  2/114 (1.75%) 
Diabetic retinal oedema * 1  9/89 (10.11%)  6/102 (5.88%)  8/114 (7.02%) 
Diabetic retinopathy * 1  0/89 (0.00%)  4/102 (3.92%)  5/114 (4.39%) 
Diplopia * 1  5/89 (5.62%)  2/102 (1.96%)  0/114 (0.00%) 
Dry eye * 1  12/89 (13.48%)  10/102 (9.80%)  8/114 (7.02%) 
Episcleritis * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Eye discharge * 1  0/89 (0.00%)  3/102 (2.94%)  0/114 (0.00%) 
Eye infection * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Eye irritation * 1  8/89 (8.99%)  9/102 (8.82%)  3/114 (2.63%) 
Eye pain * 1  22/89 (24.72%)  14/102 (13.73%)  21/114 (18.42%) 
Eye penetration * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Eye pruritus * 1  7/89 (7.87%)  8/102 (7.84%)  11/114 (9.65%) 
Eye swelling * 1  1/89 (1.12%)  1/102 (0.98%)  0/114 (0.00%) 
Eyelid disorder * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Eyelid oedema * 1  3/89 (3.37%)  3/102 (2.94%)  3/114 (2.63%) 
Eyelid ptosis * 1  1/89 (1.12%)  2/102 (1.96%)  0/114 (0.00%) 
Foreign body sensation in eyes * 1  1/89 (1.12%)  1/102 (0.98%)  4/114 (3.51%) 
Giant papillary conjunctivitis * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Glare * 1  1/89 (1.12%)  4/102 (3.92%)  0/114 (0.00%) 
Glaucoma * 1  7/89 (7.87%)  4/102 (3.92%)  3/114 (2.63%) 
Halo vision * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Hyphaema * 1  3/89 (3.37%)  2/102 (1.96%)  1/114 (0.88%) 
Hypotony of eye * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Iris adhesions * 1  1/89 (1.12%)  1/102 (0.98%)  0/114 (0.00%) 
Iris neovascularisation * 1  3/89 (3.37%)  3/102 (2.94%)  2/114 (1.75%) 
Iritis * 1  1/89 (1.12%)  0/102 (0.00%)  3/114 (2.63%) 
Keratitis * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Keratopathy * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Lacrimation increased * 1  6/89 (6.74%)  3/102 (2.94%)  9/114 (7.89%) 
Lenticular pigmentation * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Macular degeneration * 1  1/89 (1.12%)  1/102 (0.98%)  0/114 (0.00%) 
Macular fibrosis * 1  13/89 (14.61%)  10/102 (9.80%)  9/114 (7.89%) 
Macular hole * 1  0/89 (0.00%)  0/102 (0.00%)  2/114 (1.75%) 
Macular ischaemia * 1  5/89 (5.62%)  0/102 (0.00%)  1/114 (0.88%) 
Macular oedema * 1  2/89 (2.25%)  5/102 (4.90%)  7/114 (6.14%) 
Metamorphopsia * 1  5/89 (5.62%)  1/102 (0.98%)  0/114 (0.00%) 
Ocular discomfort * 1  2/89 (2.25%)  4/102 (3.92%)  4/114 (3.51%) 
Ocular hyperaemia * 1  4/89 (4.49%)  1/102 (0.98%)  7/114 (6.14%) 
Ocular hypertension * 1  2/89 (2.25%)  1/102 (0.98%)  3/114 (2.63%) 
Optic atrophy * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Optic nerve cupping * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Photophobia * 1  7/89 (7.87%)  5/102 (4.90%)  3/114 (2.63%) 
Photopsia * 1  10/89 (11.24%)  7/102 (6.86%)  5/114 (4.39%) 
Posterior capsule opacification * 1  1/89 (1.12%)  4/102 (3.92%)  2/114 (1.75%) 
Punctate keratitis * 1  2/89 (2.25%)  2/102 (1.96%)  4/114 (3.51%) 
Pupillary block * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Pupillary reflex impaired * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Retinal aneurysm * 1  2/89 (2.25%)  1/102 (0.98%)  0/114 (0.00%) 
Retinal artery embolism * 1  0/89 (0.00%)  2/102 (1.96%)  0/114 (0.00%) 
Retinal artery occlusion * 1  0/89 (0.00%)  1/102 (0.98%)  1/114 (0.88%) 
Retinal detachment * 1  12/89 (13.48%)  13/102 (12.75%)  19/114 (16.67%) 
Retinal disorder * 1  1/89 (1.12%)  2/102 (1.96%)  0/114 (0.00%) 
Retinal exudates * 1  4/89 (4.49%)  8/102 (7.84%)  0/114 (0.00%) 
Retinal haemorrhage * 1  10/89 (11.24%)  12/102 (11.76%)  8/114 (7.02%) 
Retinal ischaemia * 1  0/89 (0.00%)  2/102 (1.96%)  2/114 (1.75%) 
Retinal neovascularisation * 1  9/89 (10.11%)  15/102 (14.71%)  14/114 (12.28%) 
Retinal oedema * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Retinal tear * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Retinal vascular disorder * 1  1/89 (1.12%)  2/102 (1.96%)  0/114 (0.00%) 
Retinopathy hypertensive * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Scleritis * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Vision blurred * 1  33/89 (37.08%)  25/102 (24.51%)  26/114 (22.81%) 
Visual acuity reduced * 1  17/89 (19.10%)  20/102 (19.61%)  20/114 (17.54%) 
Visual field defect * 1  1/89 (1.12%)  1/102 (0.98%)  2/114 (1.75%) 
Visual impairment * 1  9/89 (10.11%)  8/102 (7.84%)  4/114 (3.51%) 
Vitreal cells * 1  1/89 (1.12%)  1/102 (0.98%)  0/114 (0.00%) 
Vitreous adhesions * 1  3/89 (3.37%)  3/102 (2.94%)  0/114 (0.00%) 
Vitreous detachment * 1  6/89 (6.74%)  4/102 (3.92%)  9/114 (7.89%) 
Vitreous disorder * 1  2/89 (2.25%)  1/102 (0.98%)  0/114 (0.00%) 
Vitreous floaters * 1  38/89 (42.70%)  32/102 (31.37%)  35/114 (30.70%) 
Vitreous haemorrhage * 1  37/89 (41.57%)  46/102 (45.10%)  49/114 (42.98%) 
Vitreous opacities * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Gastrointestinal disorders       
Abdominal discomfort * 1  0/89 (0.00%)  5/102 (4.90%)  0/114 (0.00%) 
Abdominal pain * 1  4/89 (4.49%)  0/102 (0.00%)  3/114 (2.63%) 
Abdominal pain upper * 1  3/89 (3.37%)  2/102 (1.96%)  1/114 (0.88%) 
Colitis ischaemic * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Colon cancer * 1  1/89 (1.12%)  0/102 (0.00%)  1/114 (0.88%) 
Constipation * 1  1/89 (1.12%)  2/102 (1.96%)  1/114 (0.88%) 
Dental caries * 1  1/89 (1.12%)  0/102 (0.00%)  1/114 (0.88%) 
Diabetic gastroparesis * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Diarrhoea * 1  3/89 (3.37%)  1/102 (0.98%)  3/114 (2.63%) 
Dyspepsia * 1  2/89 (2.25%)  1/102 (0.98%)  0/114 (0.00%) 
Food poisoning * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Gastroenteritis * 1  1/89 (1.12%)  0/102 (0.00%)  1/114 (0.88%) 
Gastroenteritis viral * 1  3/89 (3.37%)  3/102 (2.94%)  2/114 (1.75%) 
Gastrointestinal haemorrhage * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Gastrooesophageal reflux disease * 1  2/89 (2.25%)  6/102 (5.88%)  2/114 (1.75%) 
Haematochezia * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Hiatus hernia * 1  0/89 (0.00%)  1/102 (0.98%)  1/114 (0.88%) 
Intestinal obstruction * 1  0/89 (0.00%)  0/102 (0.00%)  2/114 (1.75%) 
Irritable bowel syndrome * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Lactose intolerance * 1  0/89 (0.00%)  0/102 (0.00%)  2/114 (1.75%) 
Nausea * 1  7/89 (7.87%)  9/102 (8.82%)  6/114 (5.26%) 
Oesophageal varices haemorrhage * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Pancreatitis * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Tooth abscess * 1  2/89 (2.25%)  1/102 (0.98%)  0/114 (0.00%) 
Tooth infection * 1  1/89 (1.12%)  1/102 (0.98%)  0/114 (0.00%) 
Toothache * 1  2/89 (2.25%)  1/102 (0.98%)  0/114 (0.00%) 
Vomiting * 1  4/89 (4.49%)  5/102 (4.90%)  2/114 (1.75%) 
General disorders       
Chest discomfort * 1  1/89 (1.12%)  0/102 (0.00%)  1/114 (0.88%) 
Chest pain * 1  3/89 (3.37%)  3/102 (2.94%)  2/114 (1.75%) 
Chills * 1  0/89 (0.00%)  1/102 (0.98%)  1/114 (0.88%) 
Device related infection * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Facial pain * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Fatigue * 1  2/89 (2.25%)  1/102 (0.98%)  1/114 (0.88%) 
Flank pain * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Injection site haemorrhage * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Injection site irritation * 1  0/89 (0.00%)  1/102 (0.98%)  1/114 (0.88%) 
Local swelling * 1  2/89 (2.25%)  0/102 (0.00%)  0/114 (0.00%) 
Oedema peripheral * 1  5/89 (5.62%)  4/102 (3.92%)  6/114 (5.26%) 
Pain * 1  1/89 (1.12%)  2/102 (1.96%)  3/114 (2.63%) 
Pyrexia * 1  1/89 (1.12%)  2/102 (1.96%)  0/114 (0.00%) 
Swelling * 1  2/89 (2.25%)  1/102 (0.98%)  1/114 (0.88%) 
Hepatobiliary disorders       
Cholelithiasis * 1  0/89 (0.00%)  1/102 (0.98%)  1/114 (0.88%) 
Hepatic cirrhosis * 1  0/89 (0.00%)  0/102 (0.00%)  2/114 (1.75%) 
Hepatomegaly * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Immune system disorders       
Hypersensitivity * 1  0/89 (0.00%)  1/102 (0.98%)  1/114 (0.88%) 
Seasonal allergy * 1  5/89 (5.62%)  4/102 (3.92%)  5/114 (4.39%) 
Infections and infestations       
Abscess * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Bacteraemia * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Bronchopneumonia * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Candidiasis * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Escherichia infection * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Fungal infection * 1  0/89 (0.00%)  2/102 (1.96%)  0/114 (0.00%) 
Gingival infection * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Helicobacter infection * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Infection * 1  0/89 (0.00%)  3/102 (2.94%)  2/114 (1.75%) 
Influenza * 1  7/89 (7.87%)  11/102 (10.78%)  7/114 (6.14%) 
Latent tuberculosis * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Localised infection * 1  0/89 (0.00%)  5/102 (4.90%)  0/114 (0.00%) 
Onychomycosis * 1  2/89 (2.25%)  0/102 (0.00%)  1/114 (0.88%) 
Respiratory tract infection fungal * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Staphylococcal infection * 1  1/89 (1.12%)  1/102 (0.98%)  1/114 (0.88%) 
Injury, poisoning and procedural complications       
Animal scratch * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Arthropod bite * 1  1/89 (1.12%)  0/102 (0.00%)  1/114 (0.88%) 
Burns second degree * 1  1/89 (1.12%)  1/102 (0.98%)  1/114 (0.88%) 
Fall * 1  3/89 (3.37%)  2/102 (1.96%)  3/114 (2.63%) 
Head injury * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Laceration * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Ligament rupture * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Limb injury * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Road traffic accident * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Thermal burn * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Wound * 1  2/89 (2.25%)  1/102 (0.98%)  0/114 (0.00%) 
Investigations       
Biopsy skin * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Blood creatinine abnormal * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Blood glucose decreased * 1  2/89 (2.25%)  0/102 (0.00%)  1/114 (0.88%) 
Blood glucose increased * 1  2/89 (2.25%)  0/102 (0.00%)  0/114 (0.00%) 
Blood testosterone decreased * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Cardiac murmur * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Electrocardiogram abnormal * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Glycosylated haemoglobin increased * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Intraocular pressure increased * 1  6/89 (6.74%)  4/102 (3.92%)  4/114 (3.51%) 
Laboratory test abnormal * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Low density lipoprotein increased * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Red blood cell count decreased * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Troponin increased * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Metabolism and nutrition disorders       
Acidosis * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Dehydration * 1  0/89 (0.00%)  1/102 (0.98%)  1/114 (0.88%) 
Fluid overload * 1  3/89 (3.37%)  0/102 (0.00%)  0/114 (0.00%) 
Fluid retention * 1  0/89 (0.00%)  1/102 (0.98%)  1/114 (0.88%) 
Hypercholesterolaemia * 1  5/89 (5.62%)  4/102 (3.92%)  6/114 (5.26%) 
Hyperkalaemia * 1  2/89 (2.25%)  3/102 (2.94%)  0/114 (0.00%) 
Hyperlipidaemia * 1  1/89 (1.12%)  2/102 (1.96%)  2/114 (1.75%) 
Hypertriglyceridaemia * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Hypokalaemia * 1  1/89 (1.12%)  1/102 (0.98%)  1/114 (0.88%) 
Hypomagnesaemia * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Hypophosphataemia * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Iron deficiency * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Vitamin D deficiency * 1  4/89 (4.49%)  1/102 (0.98%)  1/114 (0.88%) 
Musculoskeletal and connective tissue disorders       
Ankle fracture * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Arthralgia * 1  2/89 (2.25%)  2/102 (1.96%)  2/114 (1.75%) 
Arthritis * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Back pain * 1  2/89 (2.25%)  4/102 (3.92%)  5/114 (4.39%) 
Bursitis * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Exostosis * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Foot deformity * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Foot fracture * 1  2/89 (2.25%)  3/102 (2.94%)  2/114 (1.75%) 
Gout * 1  1/89 (1.12%)  1/102 (0.98%)  1/114 (0.88%) 
Hand fracture * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Intervertebral disc protrusion * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Ligament sprain * 1  0/89 (0.00%)  5/102 (4.90%)  3/114 (2.63%) 
Lower limb fracture * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Medial tibial stress syndrome * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Meniscus injury * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Multiple fractures * 1  2/89 (2.25%)  2/102 (1.96%)  1/114 (0.88%) 
Muscle spasms * 1  1/89 (1.12%)  0/102 (0.00%)  1/114 (0.88%) 
Muscle strain * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Muscular weakness * 1  0/89 (0.00%)  3/102 (2.94%)  2/114 (1.75%) 
Musculoskeletal discomfort * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Musculoskeletal pain * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Myalgia * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Neck pain * 1  1/89 (1.12%)  1/102 (0.98%)  1/114 (0.88%) 
Neuropathic arthropathy * 1  0/89 (0.00%)  1/102 (0.98%)  1/114 (0.88%) 
Osteoarthritis * 1  3/89 (3.37%)  1/102 (0.98%)  4/114 (3.51%) 
Osteopenia * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Osteoporosis * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Pain in extremity * 1  2/89 (2.25%)  6/102 (5.88%)  2/114 (1.75%) 
Periarthritis * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Plantar fasciitis * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Polymyalgia rheumatica * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Rheumatoid arthritis * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Rotator cuff syndrome * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Temporomandibular joint syndrome * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Trigger finger * 1  0/89 (0.00%)  1/102 (0.98%)  1/114 (0.88%) 
Wrist fracture * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Abdominal neoplasm * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Acoustic neuroma * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Hepatic cancer * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Lung cancer metastatic * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Renal cancer * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Nervous system disorders       
Balance disorder * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Carpal tunnel syndrome * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Concussion * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Dementia * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Diabetic neuropathy * 1  3/89 (3.37%)  0/102 (0.00%)  1/114 (0.88%) 
Dizziness * 1  6/89 (6.74%)  5/102 (4.90%)  4/114 (3.51%) 
Dysarthria * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Encephalopathy * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Headache * 1  15/89 (16.85%)  10/102 (9.80%)  18/114 (15.79%) 
Hydrocephalus * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Hypoaesthesia * 1  2/89 (2.25%)  0/102 (0.00%)  2/114 (1.75%) 
IIIrd nerve paralysis * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
IVth nerve paralysis * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Migraine * 1  1/89 (1.12%)  2/102 (1.96%)  1/114 (0.88%) 
Nerve injury * 1  1/89 (1.12%)  1/102 (0.98%)  0/114 (0.00%) 
Neuropathy peripheral * 1  1/89 (1.12%)  2/102 (1.96%)  0/114 (0.00%) 
Paraesthesia * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Presyncope * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Restless legs syndrome * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Sciatica * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Syncope * 1  1/89 (1.12%)  0/102 (0.00%)  1/114 (0.88%) 
Temporal arteritis * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Vertigo * 1  0/89 (0.00%)  2/102 (1.96%)  1/114 (0.88%) 
Psychiatric disorders       
Anxiety * 1  0/89 (0.00%)  2/102 (1.96%)  3/114 (2.63%) 
Depression * 1  2/89 (2.25%)  1/102 (0.98%)  8/114 (7.02%) 
Drug abuse * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Insomnia * 1  0/89 (0.00%)  2/102 (1.96%)  2/114 (1.75%) 
Stress * 1  0/89 (0.00%)  1/102 (0.98%)  1/114 (0.88%) 
Suicidal ideation * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Renal and urinary disorders       
Azotaemia * 1  0/89 (0.00%)  2/102 (1.96%)  0/114 (0.00%) 
Bladder cancer * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Cystitis * 1  1/89 (1.12%)  1/102 (0.98%)  1/114 (0.88%) 
Dysuria * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Haematuria * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Hydronephrosis * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Kidney infection * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Nephrolithiasis * 1  0/89 (0.00%)  2/102 (1.96%)  1/114 (0.88%) 
Nephropathy * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Proteinuria * 1  1/89 (1.12%)  0/102 (0.00%)  1/114 (0.88%) 
Pyelonephritis * 1  1/89 (1.12%)  1/102 (0.98%)  0/114 (0.00%) 
Renal failure * 1  5/89 (5.62%)  2/102 (1.96%)  3/114 (2.63%) 
Renal failure acute * 1  1/89 (1.12%)  0/102 (0.00%)  1/114 (0.88%) 
Renal failure chronic * 1  3/89 (3.37%)  0/102 (0.00%)  5/114 (4.39%) 
Renal impairment * 1  1/89 (1.12%)  1/102 (0.98%)  1/114 (0.88%) 
Renal osteodystrophy * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Urinary incontinence * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Urinary retention * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Urinary tract disorder * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Urinary tract infection * 1  4/89 (4.49%)  6/102 (5.88%)  4/114 (3.51%) 
Reproductive system and breast disorders       
Erectile dysfunction * 1  0/89 (0.00%)  1/102 (0.98%)  1/114 (0.88%) 
Ovarian cyst * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Prostate cancer * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Prostatitis * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Prostatomegaly * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Testicular swelling * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Uterine leiomyoma * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Respiratory, thoracic and mediastinal disorders       
Acute respiratory failure * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Asthma * 1  0/89 (0.00%)  0/102 (0.00%)  2/114 (1.75%) 
Bronchitis * 1  3/89 (3.37%)  5/102 (4.90%)  2/114 (1.75%) 
Chronic sinusitis * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Cough * 1  8/89 (8.99%)  6/102 (5.88%)  5/114 (4.39%) 
Dyspnoea * 1  6/89 (6.74%)  3/102 (2.94%)  2/114 (1.75%) 
Lung neoplasm * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Nasal congestion * 1  3/89 (3.37%)  1/102 (0.98%)  3/114 (2.63%) 
Nasopharyngitis * 1  15/89 (16.85%)  17/102 (16.67%)  10/114 (8.77%) 
Oropharyngeal pain * 1  5/89 (5.62%)  5/102 (4.90%)  0/114 (0.00%) 
Pharyngitis streptococcal * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Pleural effusion * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Pneumonia * 1  0/89 (0.00%)  1/102 (0.98%)  2/114 (1.75%) 
Pulmonary hypertension * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Pulmonary oedema * 1  1/89 (1.12%)  1/102 (0.98%)  0/114 (0.00%) 
Respiratory distress * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Respiratory tract congestion * 1  1/89 (1.12%)  1/102 (0.98%)  1/114 (0.88%) 
Respiratory tract infection * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Rhinitis allergic * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Rhinorrhoea * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Sinusitis * 1  2/89 (2.25%)  10/102 (9.80%)  7/114 (6.14%) 
Sleep apnoea syndrome * 1  0/89 (0.00%)  1/102 (0.98%)  1/114 (0.88%) 
Upper respiratory tract infection * 1  2/89 (2.25%)  4/102 (3.92%)  2/114 (1.75%) 
Wheezing * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Skin and subcutaneous tissue disorders       
Acne * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Alopecia * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Basal cell carcinoma * 1  1/89 (1.12%)  0/102 (0.00%)  2/114 (1.75%) 
Blister * 1  2/89 (2.25%)  0/102 (0.00%)  0/114 (0.00%) 
Cellulitis * 1  3/89 (3.37%)  4/102 (3.92%)  1/114 (0.88%) 
Contusion * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Dermatitis allergic * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Dermatitis contact * 1  1/89 (1.12%)  1/102 (0.98%)  0/114 (0.00%) 
Diabetic foot * 1  3/89 (3.37%)  1/102 (0.98%)  2/114 (1.75%) 
Diabetic ulcer * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Erythema * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Excoriation * 1  1/89 (1.12%)  2/102 (1.96%)  0/114 (0.00%) 
Furuncle * 1  1/89 (1.12%)  1/102 (0.98%)  1/114 (0.88%) 
Hyperhidrosis * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Hyperkeratosis * 1  2/89 (2.25%)  0/102 (0.00%)  0/114 (0.00%) 
Ingrowing nail * 1  1/89 (1.12%)  1/102 (0.98%)  0/114 (0.00%) 
Onychomycosis * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Pruritus * 1  0/89 (0.00%)  2/102 (1.96%)  0/114 (0.00%) 
Rash * 1  1/89 (1.12%)  2/102 (1.96%)  3/114 (2.63%) 
Skin disorder * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Skin infection * 1  0/89 (0.00%)  2/102 (1.96%)  0/114 (0.00%) 
Skin mass * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Skin papilloma * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Skin ulcer * 1  1/89 (1.12%)  1/102 (0.98%)  0/114 (0.00%) 
Social circumstances       
Menopause * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Surgical and medical procedures       
Abdominal panniculectomy * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Benign tumour excision * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Cataract operation * 1  0/89 (0.00%)  4/102 (3.92%)  2/114 (1.75%) 
Cholecystectomy * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Dental implantation * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Gastric banding * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Glaucoma surgery * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Retinal laser coagulation * 1  1/89 (1.12%)  3/102 (2.94%)  1/114 (0.88%) 
Skin lesion excision * 1  0/89 (0.00%)  1/102 (0.98%)  0/114 (0.00%) 
Surgery * 1  0/89 (0.00%)  3/102 (2.94%)  1/114 (0.88%) 
Tooth extraction * 1  1/89 (1.12%)  3/102 (2.94%)  0/114 (0.00%) 
Vitrectomy * 1  0/89 (0.00%)  6/102 (5.88%)  8/114 (7.02%) 
Vascular disorders       
Arteriosclerosis * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Arteriovenous fistula * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Cerebrovascular accident * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Hypertension * 1  13/89 (14.61%)  24/102 (23.53%)  18/114 (15.79%) 
Hypotension * 1  2/89 (2.25%)  1/102 (0.98%)  1/114 (0.88%) 
Iliac artery occlusion * 1  0/89 (0.00%)  0/102 (0.00%)  1/114 (0.88%) 
Peripheral artery stenosis * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Transient ischaemic attack * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
Varicose vein * 1  1/89 (1.12%)  0/102 (0.00%)  0/114 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Trial results can not be discussed until they have been made available to the public.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Adam Glassman
Organization: Jaeb Center for Health Research
Phone: 813-975-8690
EMail: drcrnet@jaeb.org
Layout table for additonal information
Responsible Party: Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT01489189     History of Changes
Other Study ID Numbers: DRCR.net Protocol S
First Submitted: December 6, 2011
First Posted: December 9, 2011
Results First Submitted: February 12, 2016
Results First Posted: June 1, 2016
Last Update Posted: July 10, 2018