Trial Outcomes & Findings for Study of Comparative Treatments for Retinal Vein Occlusion 2 (SCORE2) (NCT NCT01969708)
NCT ID: NCT01969708
Last Updated: 2021-06-22
Results Overview
The primary analysis is based on observed data at 6 months. The measure is calculated by subtracting the baseline visual acuity letter score from the month 6 visual acuity letter score. The participant is refracted for best corrected vision, and then reads single letters on an electronic visual acuity tester at a 3 meter distance according to a specific algorithm. A letter score is provided that ranges from 0 (unable to ready any letters) to 100. A visual acuity letter score of 85 corresponds to a visual acuity of 20/20 as a Snellen equivalent.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
362 participants
Primary outcome timeframe
Month 0 to 6
Results posted on
2021-06-22
Participant Flow
The SCORE2 randomized noninferiority clinical trial was conducted at 66 private practice or academic centers in the United States, and included 362 patients with macular edema due to central retinal or hemiretinal vein occlusion who were randomized 1:1 to receive aflibercept or bevacizumab.
Participants were assigned to a treatment arm at enrollment.
Participant milestones
| Measure |
Aflibercept
2.0 mg aflibercept every 4 weeks
aflibercept
|
Bevacizumab
1.25 mg bevacizumab every 4 weeks
bevacizumab
|
|---|---|---|
|
Overall Study
STARTED
|
180
|
182
|
|
Overall Study
COMPLETED
|
175
|
173
|
|
Overall Study
NOT COMPLETED
|
5
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Comparative Treatments for Retinal Vein Occlusion 2 (SCORE2)
Baseline characteristics by cohort
| Measure |
Aflibercept
n=180 Participants
2.0 mg aflibercept every 4 weeks
aflibercept
|
Bevacizumab
n=182 Participants
1.25 mg bevacizumab every 4 weeks
bevacizumab
|
Total
n=362 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
67 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
113 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
228 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
82 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
157 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
98 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
205 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
164 Participants
n=5 Participants
|
160 Participants
n=7 Participants
|
324 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
28 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
132 Participants
n=5 Participants
|
146 Participants
n=7 Participants
|
278 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
180 participants
n=5 Participants
|
182 participants
n=7 Participants
|
362 participants
n=5 Participants
|
|
Visual Acuity Letter Score (VALS) of Study Eye
|
50.3 letters read
STANDARD_DEVIATION 15.2 • n=5 Participants
|
50.4 letters read
STANDARD_DEVIATION 15.3 • n=7 Participants
|
50.3 letters read
STANDARD_DEVIATION 15.2 • n=5 Participants
|
|
Time between diagnosis of macular edema and randomization
|
8 months
STANDARD_DEVIATION 17 • n=5 Participants
|
5 months
STANDARD_DEVIATION 10 • n=7 Participants
|
7 months
STANDARD_DEVIATION 14 • n=5 Participants
|
|
Spectral Domain-Optical Coherence Tomography (SD-OCT) central subfield thickness
|
652.4 um
STANDARD_DEVIATION 214.6 • n=5 Participants
|
678.2 um
STANDARD_DEVIATION 233.3 • n=7 Participants
|
665.5 um
STANDARD_DEVIATION 224.4 • n=5 Participants
|
|
Prior anti-vascular endothelial growth factor (VEGF) treatment
|
65 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
|
Prior intravitreal steroid use
|
16 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Hemiretinal vein occlusion
|
26 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Cataract extraction
|
43 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
History of cataract
|
108 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
203 Participants
n=5 Participants
|
|
Diabetes mellitus type 1
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Diabetes mellitus type 2
|
54 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
|
Hypertensive
|
140 Participants
n=5 Participants
|
138 Participants
n=7 Participants
|
278 Participants
n=5 Participants
|
|
Coronary artery disease
|
26 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
National Eye Institute (NEI) Visual Function Questionnaire (VFQ)-25 overall score
|
77 total score
STANDARD_DEVIATION 15 • n=5 Participants
|
77 total score
STANDARD_DEVIATION 17 • n=7 Participants
|
77 total score
STANDARD_DEVIATION 16 • n=5 Participants
|
PRIMARY outcome
Timeframe: Month 0 to 6Population: All participants with visual acuity letter score recorded at Month 6
The primary analysis is based on observed data at 6 months. The measure is calculated by subtracting the baseline visual acuity letter score from the month 6 visual acuity letter score. The participant is refracted for best corrected vision, and then reads single letters on an electronic visual acuity tester at a 3 meter distance according to a specific algorithm. A letter score is provided that ranges from 0 (unable to ready any letters) to 100. A visual acuity letter score of 85 corresponds to a visual acuity of 20/20 as a Snellen equivalent.
Outcome measures
| Measure |
Aflibercept
n=175 Participants
2.0 mg aflibercept every 4 weeks
aflibercept
|
Bevacizumab
n=173 Participants
1.25 mg bevacizumab every 4 weeks
bevacizumab
|
|---|---|---|
|
Mean Change From Baseline in Best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity Letter Score at Month 6
|
18.9 letters read
Interval 16.62 to 21.15
|
18.6 letters read
Interval 16.16 to 21.09
|
SECONDARY outcome
Timeframe: Month 0 to 6Population: All participants with visual acuity letter score recorded at Month 6
The measure is the number of study eyes that gained at least 15 letters in their visual acuity letter score at month 6
Outcome measures
| Measure |
Aflibercept
n=175 Participants
2.0 mg aflibercept every 4 weeks
aflibercept
|
Bevacizumab
n=173 Participants
1.25 mg bevacizumab every 4 weeks
bevacizumab
|
|---|---|---|
|
Number of Study Eyes With Gain of ≥15 Letters in Visual Acuity Letter Score at Month 6
|
114 study eyes
|
106 study eyes
|
SECONDARY outcome
Timeframe: Month 0 to 6Population: All participants with visual acuity letter score recorded at Month 6
The measure is the number of study eyes with a visual acuity letter score of 70 (Snellen equivalent of 20/40) or better at month 6
Outcome measures
| Measure |
Aflibercept
n=175 Participants
2.0 mg aflibercept every 4 weeks
aflibercept
|
Bevacizumab
n=173 Participants
1.25 mg bevacizumab every 4 weeks
bevacizumab
|
|---|---|---|
|
Number of Study Eyes With Visual Acuity Letter Score of 70 or Better at Month 6
|
101 study eyes
|
99 study eyes
|
SECONDARY outcome
Timeframe: Month 0 to 6Population: All participants with central subfield thickness recorded at baseline and Month 6
The measure is the mean central subfield thickness at month 6 measured by spectral-domain optical coherence tomography
Outcome measures
| Measure |
Aflibercept
n=164 Participants
2.0 mg aflibercept every 4 weeks
aflibercept
|
Bevacizumab
n=171 Participants
1.25 mg bevacizumab every 4 weeks
bevacizumab
|
|---|---|---|
|
Mean Spectral-domain Optical Coherence Tomography Central Subfield Thickness
|
231.3 um
Interval 220.8 to 241.8
|
287.9 um
Interval 269.4 to 306.4
|
SECONDARY outcome
Timeframe: Month 0 to 6Population: All participants with central subfield thickness recorded at baseline and Month 6
The measure is calculated by subtracting the baseline central subfield thickness from the month 6 central subfield thickness
Outcome measures
| Measure |
Aflibercept
n=164 Participants
2.0 mg aflibercept every 4 weeks
aflibercept
|
Bevacizumab
n=171 Participants
1.25 mg bevacizumab every 4 weeks
bevacizumab
|
|---|---|---|
|
Mean Change From Baseline in Spectral Domain Optical Coherence Tomography Central Subfield Thickness at Month 6
|
-425 um
Interval -461.0 to -389.0
|
-387 um
Interval -426.0 to -348.0
|
SECONDARY outcome
Timeframe: Month 0 to 6Population: All participants with central subfield thickness recorded at Month 6
The measure is the number of study eyes with central subfield thickness \<300 μm, no subretinal fluid, no intraretinal fluid, and no cystoid spaces at month 6
Outcome measures
| Measure |
Aflibercept
n=169 Participants
2.0 mg aflibercept every 4 weeks
aflibercept
|
Bevacizumab
n=172 Participants
1.25 mg bevacizumab every 4 weeks
bevacizumab
|
|---|---|---|
|
Number of Study Eyes With Central Subfield Thickness <300 μm, no Subretinal Fluid, no Intraretinal Fluid, and no Cystoid Spaces
|
92 study eyes
|
49 study eyes
|
Adverse Events
Aflibercept
Serious events: 14 serious events
Other events: 82 other events
Deaths: 1 deaths
Bevacizumab
Serious events: 14 serious events
Other events: 98 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Aflibercept
n=180 participants at risk
2.0 mg aflibercept every 4 weeks
aflibercept
|
Bevacizumab
n=182 participants at risk
1.25 mg bevacizumab every 4 weeks
bevacizumab
|
|---|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.00%
0/182 • Month 0 to 6
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.00%
0/182 • Month 0 to 6
|
|
Psychiatric disorders
Alcohol abuse
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.00%
0/182 • Month 0 to 6
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.00%
0/182 • Month 0 to 6
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 2 • Month 0 to 6
|
|
Investigations
Blood sodium decreased
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Infections and infestations
Bronchitis
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.00%
0/182 • Month 0 to 6
|
|
Cardiac disorders
Cardiac failure congestive
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.00%
0/182 • Month 0 to 6
|
|
Nervous system disorders
Cerebrovascular accident
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.00%
0/182 • Month 0 to 6
|
|
Nervous system disorders
Cerebrovascular stenosis
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Infections and infestations
Diabetic foot infection
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.00%
0/182 • Month 0 to 6
|
|
Infections and infestations
Escherichia infection
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.00%
0/182 • Month 0 to 6
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Surgical and medical procedures
Hernia repair
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Blood and lymphatic system disorders
Hypercoagulation
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Vascular disorders
Hypertension
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.00%
0/182 • Month 0 to 6
|
|
Vascular disorders
Hypertensive crisis
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.00%
0/182 • Month 0 to 6
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoplasmacytoid lymphoma/immunocytoma
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Infections and infestations
Meningitis streptococcal
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Psychiatric disorders
Mental status changes
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.00%
0/182 • Month 0 to 6
|
|
Cardiac disorders
Myocardial infarction
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Eye disorders
Non-infectious endophthalmitis
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.00%
0/182 • Month 0 to 6
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.00%
0/182 • Month 0 to 6
|
|
Vascular disorders
Peripheral vascular disorder
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.00%
0/182 • Month 0 to 6
|
|
Infections and infestations
Pneumonia
|
0.00%
0/180 • Month 0 to 6
|
1.1%
2/182 • Number of events 2 • Month 0 to 6
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.00%
0/182 • Month 0 to 6
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.00%
0/182 • Month 0 to 6
|
|
Infections and infestations
Sepsis
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Waldenstrom's macroglobulinaemia
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
Other adverse events
| Measure |
Aflibercept
n=180 participants at risk
2.0 mg aflibercept every 4 weeks
aflibercept
|
Bevacizumab
n=182 participants at risk
1.25 mg bevacizumab every 4 weeks
bevacizumab
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Renal and urinary disorders
Acute kidney injury
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
1.1%
2/182 • Number of events 2 • Month 0 to 6
|
|
Blood and lymphatic system disorders
Anaemia
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.00%
0/182 • Month 0 to 6
|
|
Vascular disorders
Aneurysm
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Eye disorders
Angle closure glaucoma
|
0.00%
0/180 • Month 0 to 6
|
1.1%
2/182 • Number of events 2 • Month 0 to 6
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Psychiatric disorders
Anxiety
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula aneurysm
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.00%
0/182 • Month 0 to 6
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.7%
3/180 • Number of events 3 • Month 0 to 6
|
1.1%
2/182 • Number of events 2 • Month 0 to 6
|
|
General disorders
Asthenia
|
0.00%
0/180 • Month 0 to 6
|
1.1%
2/182 • Number of events 2 • Month 0 to 6
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
1.6%
3/182 • Number of events 3 • Month 0 to 6
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.00%
0/182 • Month 0 to 6
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.00%
0/182 • Month 0 to 6
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.00%
0/182 • Month 0 to 6
|
|
Eye disorders
Blepharitis
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Investigations
Blood glucose increased
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Investigations
Blood pressure increased
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
1.6%
3/182 • Number of events 3 • Month 0 to 6
|
|
Investigations
Blood sodium decreased
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Infections and infestations
Bronchitis
|
2.2%
4/180 • Number of events 4 • Month 0 to 6
|
1.1%
2/182 • Number of events 2 • Month 0 to 6
|
|
Infections and infestations
Bronchitis viral
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.00%
0/182 • Month 0 to 6
|
|
Cardiac disorders
Cardiac failure congestive
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.00%
0/182 • Month 0 to 6
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Eye disorders
Cataract
|
2.2%
4/180 • Number of events 4 • Month 0 to 6
|
1.1%
2/182 • Number of events 3 • Month 0 to 6
|
|
Eye disorders
Cataract nuclear
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Injury, poisoning and procedural complications
Cataract traumatic
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.00%
0/182 • Month 0 to 6
|
|
General disorders
Catheter site haemorrhage
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Infections and infestations
Cellulitis
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.00%
0/182 • Month 0 to 6
|
|
Nervous system disorders
Cervical radiculopathy
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.00%
0/182 • Month 0 to 6
|
|
Eye disorders
Charles Bonnet syndrome
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.00%
0/182 • Month 0 to 6
|
|
General disorders
Chest pain
|
1.7%
3/180 • Number of events 3 • Month 0 to 6
|
0.00%
0/182 • Month 0 to 6
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.00%
0/182 • Month 0 to 6
|
|
Infections and infestations
Clostridium difficile colitis
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.00%
0/182 • Month 0 to 6
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Eye disorders
Conjunctival haemorrhage
|
2.2%
4/180 • Number of events 4 • Month 0 to 6
|
7.7%
14/182 • Number of events 16 • Month 0 to 6
|
|
Eye disorders
Conjunctival hyperaemia
|
0.56%
1/180 • Number of events 4 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Eye disorders
Conjunctival oedema
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Gastrointestinal disorders
Constipation
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Injury, poisoning and procedural complications
Contusion
|
1.1%
2/180 • Number of events 2 • Month 0 to 6
|
0.00%
0/182 • Month 0 to 6
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.7%
3/180 • Number of events 3 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
General disorders
Cyst
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
1.1%
2/182 • Number of events 2 • Month 0 to 6
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Infections and infestations
Diverticulitis
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Nervous system disorders
Dizziness
|
1.1%
2/180 • Number of events 2 • Month 0 to 6
|
1.1%
2/182 • Number of events 3 • Month 0 to 6
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Eye disorders
Dry eye
|
0.56%
1/180 • Number of events 2 • Month 0 to 6
|
1.1%
2/182 • Number of events 3 • Month 0 to 6
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.00%
0/182 • Month 0 to 6
|
|
Surgical and medical procedures
Endodontic procedure
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.00%
0/182 • Month 0 to 6
|
|
Eye disorders
Eye irritation
|
1.7%
3/180 • Number of events 3 • Month 0 to 6
|
1.1%
2/182 • Number of events 3 • Month 0 to 6
|
|
Eye disorders
Eye pain
|
3.3%
6/180 • Number of events 8 • Month 0 to 6
|
1.6%
3/182 • Number of events 3 • Month 0 to 6
|
|
Eye disorders
Eye pruritus
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Eye disorders
Eye swelling
|
0.00%
0/180 • Month 0 to 6
|
1.1%
2/182 • Number of events 2 • Month 0 to 6
|
|
Eye disorders
Eyelid disorder
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Eye disorders
Eyelid pain
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.00%
0/182 • Month 0 to 6
|
|
General disorders
Facial pain
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.00%
0/182 • Month 0 to 6
|
|
Injury, poisoning and procedural complications
Fall
|
1.1%
2/180 • Number of events 2 • Month 0 to 6
|
2.7%
5/182 • Number of events 5 • Month 0 to 6
|
|
Eye disorders
Foreign body sensation in eyes
|
0.56%
1/180 • Number of events 3 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Infections and infestations
Gastroenteritis viral
|
1.1%
2/180 • Number of events 2 • Month 0 to 6
|
0.00%
0/182 • Month 0 to 6
|
|
Infections and infestations
Gingivitis
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.00%
0/182 • Month 0 to 6
|
|
Eye disorders
Glaucoma
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Gastrointestinal disorders
Haematochezia
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.00%
0/182 • Month 0 to 6
|
|
Vascular disorders
Haematoma
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.00%
0/182 • Month 0 to 6
|
|
Infections and infestations
Haematoma infection
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.00%
0/182 • Month 0 to 6
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Nervous system disorders
Headache
|
1.1%
2/180 • Number of events 2 • Month 0 to 6
|
3.3%
6/182 • Number of events 6 • Month 0 to 6
|
|
Infections and infestations
Herpes zoster
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.00%
0/182 • Month 0 to 6
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Vascular disorders
Hypertension
|
1.7%
3/180 • Number of events 3 • Month 0 to 6
|
2.7%
5/182 • Number of events 5 • Month 0 to 6
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.00%
0/182 • Month 0 to 6
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Endocrine disorders
Hypothyroidism
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.00%
0/182 • Month 0 to 6
|
|
Infections and infestations
Influenza
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Investigations
Intraocular pressure increased
|
0.56%
1/180 • Number of events 2 • Month 0 to 6
|
2.7%
5/182 • Number of events 5 • Month 0 to 6
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Eye disorders
Keratopathy
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.00%
0/182 • Month 0 to 6
|
|
Eye disorders
Lacrimation increased
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.55%
1/182 • Number of events 2 • Month 0 to 6
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.00%
0/182 • Month 0 to 6
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Infections and infestations
Localised infection
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.00%
0/182 • Month 0 to 6
|
|
Eye disorders
Macular hole
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.00%
0/182 • Month 0 to 6
|
|
Eye disorders
Macular ischaemia
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Eye disorders
Macular oedema
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Eye disorders
Maculopathy
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.00%
0/182 • Month 0 to 6
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Eye disorders
Metamorphopsia
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Nervous system disorders
Migraine
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/180 • Month 0 to 6
|
1.1%
2/182 • Number of events 2 • Month 0 to 6
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.00%
0/182 • Month 0 to 6
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Cardiac disorders
Myocardial infarction
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.00%
0/182 • Month 0 to 6
|
|
Infections and infestations
Nasopharyngitis
|
1.7%
3/180 • Number of events 3 • Month 0 to 6
|
3.3%
6/182 • Number of events 6 • Month 0 to 6
|
|
Gastrointestinal disorders
Nausea
|
1.1%
2/180 • Number of events 2 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Eye disorders
Ocular discomfort
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Eye disorders
Ocular hypertension
|
0.56%
1/180 • Number of events 2 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Eye disorders
Ophthalmoplegia
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Eye disorders
Optic disc hyperaemia
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Nervous system disorders
Optic neuritis
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/180 • Month 0 to 6
|
1.1%
2/182 • Number of events 2 • Month 0 to 6
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/180 • Month 0 to 6
|
1.1%
2/182 • Number of events 2 • Month 0 to 6
|
|
Eye disorders
Papilloedema
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Nervous system disorders
Parkinson's disease
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.00%
0/182 • Month 0 to 6
|
|
Injury, poisoning and procedural complications
Periorbital haemorrhage
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Surgical and medical procedures
Peripheral nerve decompression
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Eye disorders
Photophobia
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.55%
1/182 • Number of events 2 • Month 0 to 6
|
|
Eye disorders
Photopsia
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Infections and infestations
Pneumonia
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.00%
0/182 • Month 0 to 6
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Eye disorders
Posterior capsule opacification
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.00%
0/180 • Month 0 to 6
|
1.1%
2/182 • Number of events 2 • Month 0 to 6
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/180 • Month 0 to 6
|
1.1%
2/182 • Number of events 2 • Month 0 to 6
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
General disorders
Pyrexia
|
0.00%
0/180 • Month 0 to 6
|
1.1%
2/182 • Number of events 2 • Month 0 to 6
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.00%
0/182 • Month 0 to 6
|
|
Infections and infestations
Respiratory tract congestion
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.00%
0/182 • Month 0 to 6
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/180 • Month 0 to 6
|
1.1%
2/182 • Number of events 2 • Month 0 to 6
|
|
Eye disorders
Retinal collateral vessels
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Eye disorders
Retinal exudates
|
1.1%
2/180 • Number of events 2 • Month 0 to 6
|
1.6%
3/182 • Number of events 3 • Month 0 to 6
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/180 • Month 0 to 6
|
1.6%
3/182 • Number of events 3 • Month 0 to 6
|
|
Eye disorders
Retinal vascular disorder
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Eye disorders
Retinal vein occlusion
|
1.1%
2/180 • Number of events 2 • Month 0 to 6
|
1.1%
2/182 • Number of events 2 • Month 0 to 6
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.00%
0/182 • Month 0 to 6
|
|
Immune system disorders
Sarcoidosis
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Nervous system disorders
Sciatica
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Immune system disorders
Seasonal allergy
|
1.7%
3/180 • Number of events 3 • Month 0 to 6
|
0.00%
0/182 • Month 0 to 6
|
|
Infections and infestations
Sinusitis
|
1.1%
2/180 • Number of events 2 • Month 0 to 6
|
2.7%
5/182 • Number of events 5 • Month 0 to 6
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Gastrointestinal disorders
Stomatitis
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.00%
0/182 • Month 0 to 6
|
|
Eye disorders
Subretinal fluid
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.00%
0/182 • Month 0 to 6
|
|
Nervous system disorders
Syncope
|
0.00%
0/180 • Month 0 to 6
|
1.1%
2/182 • Number of events 2 • Month 0 to 6
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.00%
0/182 • Month 0 to 6
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Infections and infestations
Tooth infection
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.00%
0/182 • Month 0 to 6
|
|
Nervous system disorders
Tremor
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Infections and infestations
Upper respiratory tract infection
|
1.1%
2/180 • Number of events 2 • Month 0 to 6
|
1.1%
2/182 • Number of events 2 • Month 0 to 6
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Infections and infestations
Urinary tract infection
|
1.7%
3/180 • Number of events 3 • Month 0 to 6
|
3.3%
6/182 • Number of events 6 • Month 0 to 6
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.00%
0/182 • Month 0 to 6
|
|
Ear and labyrinth disorders
Vertigo
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.00%
0/182 • Month 0 to 6
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.00%
0/182 • Month 0 to 6
|
|
Eye disorders
Vision blurred
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
2.7%
5/182 • Number of events 8 • Month 0 to 6
|
|
Eye disorders
Visual acuity reduced
|
1.7%
3/180 • Number of events 4 • Month 0 to 6
|
3.8%
7/182 • Number of events 7 • Month 0 to 6
|
|
Eye disorders
Visual impairment
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.00%
0/182 • Month 0 to 6
|
|
Eye disorders
Vitreous adhesions
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.00%
0/182 • Month 0 to 6
|
|
Eye disorders
Vitreous detachment
|
3.3%
6/180 • Number of events 6 • Month 0 to 6
|
1.6%
3/182 • Number of events 3 • Month 0 to 6
|
|
Eye disorders
Vitreous floaters
|
3.3%
6/180 • Number of events 6 • Month 0 to 6
|
4.4%
8/182 • Number of events 8 • Month 0 to 6
|
|
Eye disorders
Vitreous opacities
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Reproductive system and breast disorders
Vulva cyst
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Injury, poisoning and procedural complications
Wound
|
0.56%
1/180 • Number of events 1 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/180 • Month 0 to 6
|
0.55%
1/182 • Number of events 1 • Month 0 to 6
|
Additional Information
Principal Investigator of the SCORE2 Data Coordinating Center
The Emmes Corporation
Phone: 301-251-1161
Email: [email protected]
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