Trial Outcomes & Findings for An Open-label Extended Clinical Protocol of Ranibizumab to Evaluate Safety and Efficacy in Rare VEGF Driven Ocular Diseases. (NCT NCT01908816)
NCT ID: NCT01908816
Last Updated: 2019-08-12
Results Overview
Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs) for ocular and non-ocular events. Due to early termination, only descriptive analysis was conducted.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
270 participants
Primary outcome timeframe
24 months
Results posted on
2019-08-12
Participant Flow
open-label, single arm study evaluating the safety of 0.5 mg ranibizumab. Patients received individualized ranibizumab intravitreal injections based on evidence of disease activity. The study was early terminated due to low recruitment that hampered to address the primary endpoint of the study
Participant milestones
| Measure |
CNV (Choroidal Neovascularization)
All patients received 0.5 mg ranibizumab IVT injection
|
ME (Macular Edema)
All patients received 0.5 mg ranibizumab IVT injection
|
RI/NVG (Rubeosis Iridis and Neovacular Glaucoma)
All patients received 0.5 mg ranibizumab IVT injection
|
PDR/V
(Proliferative Diabetic Retinopathy requiring Vitrectomy). All patients received 0.5 mg ranibizumab IVT injection
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
93
|
84
|
58
|
35
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
93
|
84
|
58
|
35
|
Reasons for withdrawal
| Measure |
CNV (Choroidal Neovascularization)
All patients received 0.5 mg ranibizumab IVT injection
|
ME (Macular Edema)
All patients received 0.5 mg ranibizumab IVT injection
|
RI/NVG (Rubeosis Iridis and Neovacular Glaucoma)
All patients received 0.5 mg ranibizumab IVT injection
|
PDR/V
(Proliferative Diabetic Retinopathy requiring Vitrectomy). All patients received 0.5 mg ranibizumab IVT injection
|
|---|---|---|---|---|
|
Overall Study
Subject's no longer requires study drug
|
0
|
0
|
0
|
1
|
|
Overall Study
Protocol deviation
|
1
|
2
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
4
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
3
|
5
|
4
|
2
|
|
Overall Study
Death
|
1
|
0
|
7
|
1
|
|
Overall Study
Unsatisfactory therapeutic effect
|
1
|
13
|
1
|
0
|
|
Overall Study
Early termination
|
87
|
60
|
43
|
28
|
Baseline Characteristics
An Open-label Extended Clinical Protocol of Ranibizumab to Evaluate Safety and Efficacy in Rare VEGF Driven Ocular Diseases.
Baseline characteristics by cohort
| Measure |
CNV (Choroidal Neovascularization)
n=93 Participants
All patients received 0.5 mg ranibizumab IVT injection
|
ME (Macular Edema)
n=84 Participants
All patients received 0.5 mg ranibizumab IVT injection
|
RI/NVG (Rubeosis Iridis and Neovacular Glaucoma)
n=56 Participants
All patients received 0.5 mg ranibizumab IVT injection
|
PDR/V
n=34 Participants
(Proliferative Diabetic Retinopathy requiring Vitrectomy). All patients received 0.5 mg ranibizumab IVT injection
|
Total
n=267 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
49.7 Years
STANDARD_DEVIATION 16.85 • n=5 Participants
|
64.5 Years
STANDARD_DEVIATION 13.99 • n=7 Participants
|
70.9 Years
STANDARD_DEVIATION 13.02 • n=5 Participants
|
56.5 Years
STANDARD_DEVIATION 9.86 • n=4 Participants
|
59.7 Years
STANDARD_DEVIATION 16.62 • n=21 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
126 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
141 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: Safety population: all patients who received at least one application of study treatment and had at least one post-baseline safety assessment. The statement that a patient had no adverse events also constituted a safety assessment. All safety evaluations were carried out on the safety population.
Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs) for ocular and non-ocular events. Due to early termination, only descriptive analysis was conducted.
Outcome measures
| Measure |
CNV (Choroidal Neovascularization)
n=93 Participants
All patients received 0.5 mg ranibizumab IVT injection
|
ME (Macular Edema)
n=84 Participants
All patients received 0.5 mg ranibizumab IVT injection
|
RI/NVG (Rubeosis Iridis and Neovacular Glaucoma)
n=58 Participants
All patients received 0.5 mg ranibizumab IVT injection
|
PDR/V
n=35 Participants
(Proliferative Diabetic Retinopathy requiring Vitrectomy). All patients received 0.5 mg ranibizumab IVT injection
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Non- serious adverse events
|
2 Participants
|
21 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Serious adverse events
|
11 Participants
|
15 Participants
|
31 Participants
|
14 Participants
|
|
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Death
|
1 Participants
|
0 Participants
|
7 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 3 months, 12 monthsPopulation: Intent-to-treat population (ITT): all patients who received at least one application of study treatment and had at least one post-baseline efficacy assessment. The ITT population was the main analysis set for efficacy evaluations
BCVA change for diseases affecting the macular area either through CNV or ME. BCVA is tested using the ETDRS (Early Treatment Diabetic Retinopathy Study), the Snellen or Monoyer scales. The three scales are designed to measure visual acuity. ETDRS score is expressed in letter, Snellen and Monoyer score in fraction. BCVA assessment is presented in ETDRS after conversion if collected in Snellen or Monoyer. (Monoyer converted to Snellen = 2 x (Monoyer fraction) and Snellen converted to approximate ETDRS letters = 1x log(Snellen fraction). ETDRS letter score was transformed in logMAR unit for statistical analysis (- LogMAR = -(ETDRS-85)/50). The worse ETDRS letter score is 0 (logMAR 2.3) and the best ETDRS letter score is 100 (logMAR -0.3).
Outcome measures
| Measure |
CNV (Choroidal Neovascularization)
n=93 Participants
All patients received 0.5 mg ranibizumab IVT injection
|
ME (Macular Edema)
n=84 Participants
All patients received 0.5 mg ranibizumab IVT injection
|
RI/NVG (Rubeosis Iridis and Neovacular Glaucoma)
All patients received 0.5 mg ranibizumab IVT injection
|
PDR/V
(Proliferative Diabetic Retinopathy requiring Vitrectomy). All patients received 0.5 mg ranibizumab IVT injection
|
|---|---|---|---|---|
|
Change From Baseline Best Corrected Visual Acuity (BCVA) for Patients With Choroidal Neovascularization (CNV) and Macular Edema (ME)
3 Month
|
7.3 Letters
Standard Deviation 14.47
|
4.5 Letters
Standard Deviation 11.61
|
—
|
—
|
|
Change From Baseline Best Corrected Visual Acuity (BCVA) for Patients With Choroidal Neovascularization (CNV) and Macular Edema (ME)
12 Month
|
5.7 Letters
Standard Deviation 12.08
|
5.2 Letters
Standard Deviation 16.46
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 month, 12 monthPopulation: Intent-to-treat population (ITT): all patients who received at least one application of study treatment and had at least one post-baseline efficacy assessment. The ITT population was the main analysis set for efficacy evaluations
The extent of iris neovascularization was assessed by iris photography and graded using the "Teich and Walsh grading system". This grading system measures the number of quadrant at iris pupillary zone or iris ciliary zone where iris neovascularization (NV) is observed. Grade 0 = "No iris vascularization", Grade 1= Less than 2 quadrants of NV at iris pupillary zone, Grade 2 = More than 2 quadrants of NV at iris pupillary zone, Grade 3 =Grade 2 + less than 3 quadrants of NV at iris ciliary zone and/or ectropion uveae; Grade 4 =More than 3 quadrants of NV at iris ciliary zone and/or ectropion uveae)
Outcome measures
| Measure |
CNV (Choroidal Neovascularization)
n=56 Participants
All patients received 0.5 mg ranibizumab IVT injection
|
ME (Macular Edema)
All patients received 0.5 mg ranibizumab IVT injection
|
RI/NVG (Rubeosis Iridis and Neovacular Glaucoma)
All patients received 0.5 mg ranibizumab IVT injection
|
PDR/V
(Proliferative Diabetic Retinopathy requiring Vitrectomy). All patients received 0.5 mg ranibizumab IVT injection
|
|---|---|---|---|---|
|
Average Change of Neovascularization Extension for Patients With Neovascular Glaucoma
3 Month,Grade 0
|
12 Teich and Walsh grading
|
—
|
—
|
—
|
|
Average Change of Neovascularization Extension for Patients With Neovascular Glaucoma
3 Month, Grade 1
|
6 Teich and Walsh grading
|
—
|
—
|
—
|
|
Average Change of Neovascularization Extension for Patients With Neovascular Glaucoma
3 Month, Grade 2
|
8 Teich and Walsh grading
|
—
|
—
|
—
|
|
Average Change of Neovascularization Extension for Patients With Neovascular Glaucoma
3 Month, Grade 3
|
3 Teich and Walsh grading
|
—
|
—
|
—
|
|
Average Change of Neovascularization Extension for Patients With Neovascular Glaucoma
3 Month, Grade 4
|
2 Teich and Walsh grading
|
—
|
—
|
—
|
|
Average Change of Neovascularization Extension for Patients With Neovascular Glaucoma
12 Month, Grade 0
|
11 Teich and Walsh grading
|
—
|
—
|
—
|
|
Average Change of Neovascularization Extension for Patients With Neovascular Glaucoma
12 Month, Grade 1
|
4 Teich and Walsh grading
|
—
|
—
|
—
|
|
Average Change of Neovascularization Extension for Patients With Neovascular Glaucoma
12 Month, Grade 2
|
2 Teich and Walsh grading
|
—
|
—
|
—
|
|
Average Change of Neovascularization Extension for Patients With Neovascular Glaucoma
12 Month, Grade 3
|
4 Teich and Walsh grading
|
—
|
—
|
—
|
|
Average Change of Neovascularization Extension for Patients With Neovascular Glaucoma
12 Month, Grade 4
|
4 Teich and Walsh grading
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 months, 12 monthPopulation: Intent-to-treat population (ITT): all patients who received at least one application of study treatment and had at least one post-baseline efficacy assessment. The ITT population was the main analysis set for efficacy evaluations. (n) is the number of participants with an observed value
Occurrence of postoperative vitreous cavity hemorrhage
Outcome measures
| Measure |
CNV (Choroidal Neovascularization)
n=34 Participants
All patients received 0.5 mg ranibizumab IVT injection
|
ME (Macular Edema)
All patients received 0.5 mg ranibizumab IVT injection
|
RI/NVG (Rubeosis Iridis and Neovacular Glaucoma)
All patients received 0.5 mg ranibizumab IVT injection
|
PDR/V
(Proliferative Diabetic Retinopathy requiring Vitrectomy). All patients received 0.5 mg ranibizumab IVT injection
|
|---|---|---|---|---|
|
Proportion of Patient With Vitreous Cavity Hemorrhage Occurrence for Patient With Proliferative Retinopathy
3 Month Absent
|
14 Participants
|
—
|
—
|
—
|
|
Proportion of Patient With Vitreous Cavity Hemorrhage Occurrence for Patient With Proliferative Retinopathy
3 Month Present
|
3 Participants
|
—
|
—
|
—
|
|
Proportion of Patient With Vitreous Cavity Hemorrhage Occurrence for Patient With Proliferative Retinopathy
12 Month Absent
|
12 Participants
|
—
|
—
|
—
|
|
Proportion of Patient With Vitreous Cavity Hemorrhage Occurrence for Patient With Proliferative Retinopathy
12 Month Present
|
1 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 months, 12 monthPopulation: Intent-to-treat population (ITT): all patients who received at least one application of study treatment and had at least one post-baseline efficacy assessment. The ITT population was the main analysis set for efficacy evaluations
CRT in micrometers assessed by Optical Tomography (OCT) at each single study visit. A reduction is thickness indicates an improvement is the lesion area
Outcome measures
| Measure |
CNV (Choroidal Neovascularization)
n=93 Participants
All patients received 0.5 mg ranibizumab IVT injection
|
ME (Macular Edema)
n=84 Participants
All patients received 0.5 mg ranibizumab IVT injection
|
RI/NVG (Rubeosis Iridis and Neovacular Glaucoma)
All patients received 0.5 mg ranibizumab IVT injection
|
PDR/V
(Proliferative Diabetic Retinopathy requiring Vitrectomy). All patients received 0.5 mg ranibizumab IVT injection
|
|---|---|---|---|---|
|
Mean Change From Baseline in Change in Central Retinal Thickness for Patients With CNV (Choroidal Neovascularization) and ME (Macular Edema)"
3 Month
|
-54.4 μm
Standard Deviation 104.55
|
-84.4 μm
Standard Deviation 178.28
|
—
|
—
|
|
Mean Change From Baseline in Change in Central Retinal Thickness for Patients With CNV (Choroidal Neovascularization) and ME (Macular Edema)"
12 Month
|
-56.4 μm
Standard Deviation 69.82
|
-102.0 μm
Standard Deviation 220
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 months, 12 monthPopulation: Intent-to-treat population (ITT): all patients who received at least one application of study treatment and had at least one post-baseline efficacy assessment. The ITT population was the main analysis set for efficacy evaluations. The (n) represent the number of assessed value.
Angiography was taken via fluorescein angiography. Any increases of angiographic leakage was counted between baseline and month 3. Also any decreases of angiographic leakage was counted between baseline and 3 month.
Outcome measures
| Measure |
CNV (Choroidal Neovascularization)
n=93 Participants
All patients received 0.5 mg ranibizumab IVT injection
|
ME (Macular Edema)
n=84 Participants
All patients received 0.5 mg ranibizumab IVT injection
|
RI/NVG (Rubeosis Iridis and Neovacular Glaucoma)
n=34 Participants
All patients received 0.5 mg ranibizumab IVT injection
|
PDR/V
(Proliferative Diabetic Retinopathy requiring Vitrectomy). All patients received 0.5 mg ranibizumab IVT injection
|
|---|---|---|---|---|
|
Proportion of Patients With Angiographic Leakage
12 Month Absent
|
3 Participants
|
1 Participants
|
—
|
—
|
|
Proportion of Patients With Angiographic Leakage
3 Month Absent
|
3 Participants
|
3 Participants
|
1 Participants
|
—
|
|
Proportion of Patients With Angiographic Leakage
3 Month Present
|
3 Participants
|
3 Participants
|
0 Participants
|
—
|
|
Proportion of Patients With Angiographic Leakage
12 Month Present
|
2 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 months, 12 monthPopulation: Safety set population: all patients who received at least one application of study treatment and had at least one post-baseline safety assessment. The statement that a patient had no adverse events also constituted a safety assessment. All safety evaluations were carried out on the safety population.
Number of ranibizumab injections needed by decreased visual acuity and/or increasing retinal thickness in 3 months of observation period
Outcome measures
| Measure |
CNV (Choroidal Neovascularization)
n=93 Participants
All patients received 0.5 mg ranibizumab IVT injection
|
ME (Macular Edema)
n=84 Participants
All patients received 0.5 mg ranibizumab IVT injection
|
RI/NVG (Rubeosis Iridis and Neovacular Glaucoma)
n=58 Participants
All patients received 0.5 mg ranibizumab IVT injection
|
PDR/V
n=35 Participants
(Proliferative Diabetic Retinopathy requiring Vitrectomy). All patients received 0.5 mg ranibizumab IVT injection
|
|---|---|---|---|---|
|
Ranibizumab Injection
3 Month
|
2.5 Number of injections
Standard Deviation 1.03
|
2.7 Number of injections
Standard Deviation 0.88
|
1.7 Number of injections
Standard Deviation 0.79
|
1.6 Number of injections
Standard Deviation 1.0
|
|
Ranibizumab Injection
12 Month
|
3.8 Number of injections
Standard Deviation 2.34
|
3.9 Number of injections
Standard Deviation 2.17
|
3.0 Number of injections
Standard Deviation 1.96
|
1.7 Number of injections
Standard Deviation 1.44
|
Adverse Events
Choroidal Neovascularization
Serious events: 11 serious events
Other events: 46 other events
Deaths: 1 deaths
Macular Edema
Serious events: 15 serious events
Other events: 66 other events
Deaths: 0 deaths
Rubeosis Iridis/ Neovascular Glaucoma
Serious events: 31 serious events
Other events: 40 other events
Deaths: 7 deaths
Proliferative Diabetic Retinopathy Requiring Vitrectomy
Serious events: 14 serious events
Other events: 21 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Choroidal Neovascularization
n=93 participants at risk
Choroidal neovascularization
|
Macular Edema
n=84 participants at risk
Macular edema
|
Rubeosis Iridis/ Neovascular Glaucoma
n=58 participants at risk
Rubeosis iridis/ Neovascular glaucoma
|
Proliferative Diabetic Retinopathy Requiring Vitrectomy
n=35 participants at risk
Proliferative diabetic retinopathy requiring vitrectomy
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
2.9%
1/35 • up to 3 years
AE additional description
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
2.9%
1/35 • up to 3 years
AE additional description
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
6.9%
4/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Cardiac disorders
Right ventricular failure
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Anterior chamber fibrin (Study eye)
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Blindness (Both eyes)
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
2.9%
1/35 • up to 3 years
AE additional description
|
|
Eye disorders
Cataract (Contralateral eye)
|
0.00%
0/93 • up to 3 years
AE additional description
|
2.4%
2/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Cataract (Study eye)
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
2.9%
1/35 • up to 3 years
AE additional description
|
|
Eye disorders
Glaucoma (Contralateral eye)
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
2.9%
1/35 • up to 3 years
AE additional description
|
|
Eye disorders
Glaucoma (Study eye)
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
3.4%
2/58 • up to 3 years
AE additional description
|
2.9%
1/35 • up to 3 years
AE additional description
|
|
Eye disorders
Macular detachment (Both eyes)
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
2.9%
1/35 • up to 3 years
AE additional description
|
|
Eye disorders
Macular fibrosis (Study eye)
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Ocular hypertension (Both eyes)
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Ocular hypertension (Study eye)
|
1.1%
1/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
12.1%
7/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Retinal artery occlusion (Both eyes)
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
2.9%
1/35 • up to 3 years
AE additional description
|
|
Eye disorders
Retinal detachment (Study eye)
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
5.2%
3/58 • up to 3 years
AE additional description
|
2.9%
1/35 • up to 3 years
AE additional description
|
|
Eye disorders
Retinal pigment epithelial tear (Study eye)
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Retinal tear (Study eye)
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
2.9%
1/35 • up to 3 years
AE additional description
|
|
Eye disorders
Visual acuity reduced (Both eyes)
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Visual acuity reduced (Study eye)
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
2.9%
1/35 • up to 3 years
AE additional description
|
|
Eye disorders
Vitreous adhesions (Contralateral eye)
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
2.9%
1/35 • up to 3 years
AE additional description
|
|
Eye disorders
Vitreous adhesions (Study eye)
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Vitreous haemorrhage (Contralateral eye)
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
3.4%
2/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Vitreous haemorrhage (Study eye)
|
0.00%
0/93 • up to 3 years
AE additional description
|
2.4%
2/84 • up to 3 years
AE additional description
|
3.4%
2/58 • up to 3 years
AE additional description
|
2.9%
1/35 • up to 3 years
AE additional description
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Gastrointestinal disorders
Gastrointestinal angiodysplasia
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
2.9%
1/35 • up to 3 years
AE additional description
|
|
Gastrointestinal disorders
Gastrointestinal dysplasia
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Gastrointestinal disorders
Pancreatic mass
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
General disorders
Chest pain
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
2.9%
1/35 • up to 3 years
AE additional description
|
|
General disorders
Drug ineffective (Study eye)
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
General disorders
General physical health deterioration
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
2.9%
1/35 • up to 3 years
AE additional description
|
|
Hepatobiliary disorders
Jaundice
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Infections and infestations
Corneal abscess (Study eye)
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Infections and infestations
Infection
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Infections and infestations
Influenza
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Infections and infestations
Lung infection
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Infections and infestations
Peritonsillar abscess
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Infections and infestations
Pneumonia
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Infections and infestations
Syphilis
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
2.9%
1/35 • up to 3 years
AE additional description
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
3.4%
2/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
2.9%
1/35 • up to 3 years
AE additional description
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Investigations
Intraocular pressure increased (Study eye)
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
3.4%
2/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
8.6%
3/35 • up to 3 years
AE additional description
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Musculoskeletal and connective tissue disorders
Osteoarthropathy
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
2.9%
1/35 • up to 3 years
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Choroid melanoma (Study eye)
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Nervous system disorders
Akinesia
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/93 • up to 3 years
AE additional description
|
2.4%
2/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Nervous system disorders
Cognitive disorder
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Nervous system disorders
Dizziness
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Nervous system disorders
Hypoglycaemic coma
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Psychiatric disorders
Hallucination
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Renal and urinary disorders
Nephroangiosclerosis
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
3.4%
2/58 • up to 3 years
AE additional description
|
2.9%
1/35 • up to 3 years
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
2.9%
1/35 • up to 3 years
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Vascular disorders
Arterial disorder
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Vascular disorders
Extremity necrosis
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
2.9%
1/35 • up to 3 years
AE additional description
|
|
Vascular disorders
Hypertension
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
2.9%
1/35 • up to 3 years
AE additional description
|
|
Vascular disorders
Peripheral artery stenosis
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
2.9%
1/35 • up to 3 years
AE additional description
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
2.9%
1/35 • up to 3 years
AE additional description
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
2.9%
1/35 • up to 3 years
AE additional description
|
Other adverse events
| Measure |
Choroidal Neovascularization
n=93 participants at risk
Choroidal neovascularization
|
Macular Edema
n=84 participants at risk
Macular edema
|
Rubeosis Iridis/ Neovascular Glaucoma
n=58 participants at risk
Rubeosis iridis/ Neovascular glaucoma
|
Proliferative Diabetic Retinopathy Requiring Vitrectomy
n=35 participants at risk
Proliferative diabetic retinopathy requiring vitrectomy
|
|---|---|---|---|---|
|
General disorders
Drug ineffective (Study eye)
|
3.2%
3/93 • up to 3 years
AE additional description
|
32.1%
27/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
General disorders
Fatigue
|
2.2%
2/93 • up to 3 years
AE additional description
|
3.6%
3/84 • up to 3 years
AE additional description
|
6.9%
4/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Infections and infestations
Bronchitis
|
1.1%
1/93 • up to 3 years
AE additional description
|
3.6%
3/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
2.9%
1/35 • up to 3 years
AE additional description
|
|
Infections and infestations
Conjunctivitis (Both eyes)
|
1.1%
1/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
2.9%
1/35 • up to 3 years
AE additional description
|
|
Infections and infestations
Conjunctivitis (Study eye)
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
2.9%
1/35 • up to 3 years
AE additional description
|
|
Infections and infestations
Influenza
|
4.3%
4/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
2.9%
1/35 • up to 3 years
AE additional description
|
|
Infections and infestations
Sinusitis
|
2.2%
2/93 • up to 3 years
AE additional description
|
2.4%
2/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/93 • up to 3 years
AE additional description
|
2.4%
2/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
2.9%
1/35 • up to 3 years
AE additional description
|
|
Infections and infestations
Viral upper respiratory tract infection
|
1.1%
1/93 • up to 3 years
AE additional description
|
3.6%
3/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Injury, poisoning and procedural complications
Fall
|
1.1%
1/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Injury, poisoning and procedural complications
Inappropriate schedule of drug administration (Study eye)
|
11.8%
11/93 • up to 3 years
AE additional description
|
25.0%
21/84 • up to 3 years
AE additional description
|
6.9%
4/58 • up to 3 years
AE additional description
|
2.9%
1/35 • up to 3 years
AE additional description
|
|
Injury, poisoning and procedural complications
Incorrect product storage (Study eye)
|
4.3%
4/93 • up to 3 years
AE additional description
|
7.1%
6/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Investigations
Blood urea increased
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
5.7%
2/35 • up to 3 years
AE additional description
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.1%
1/93 • up to 3 years
AE additional description
|
3.6%
3/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.3%
4/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Nervous system disorders
Dizziness
|
1.1%
1/93 • up to 3 years
AE additional description
|
4.8%
4/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Nervous system disorders
Headache
|
7.5%
7/93 • up to 3 years
AE additional description
|
4.8%
4/84 • up to 3 years
AE additional description
|
3.4%
2/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Psychiatric disorders
Depression
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
3.4%
2/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
2.2%
2/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
2.9%
1/35 • up to 3 years
AE additional description
|
|
Vascular disorders
Haematoma
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
3.4%
2/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Vascular disorders
Hypertension
|
1.1%
1/93 • up to 3 years
AE additional description
|
2.4%
2/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Cataract (Study eye)
|
0.00%
0/93 • up to 3 years
AE additional description
|
3.6%
3/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Conjunctival haemorrhage (Study eye)
|
0.00%
0/93 • up to 3 years
AE additional description
|
4.8%
4/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
2.9%
1/35 • up to 3 years
AE additional description
|
|
Eye disorders
Dry eye (Study eye)
|
0.00%
0/93 • up to 3 years
AE additional description
|
2.4%
2/84 • up to 3 years
AE additional description
|
3.4%
2/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Eye pain (Study eye)
|
6.5%
6/93 • up to 3 years
AE additional description
|
6.0%
5/84 • up to 3 years
AE additional description
|
12.1%
7/58 • up to 3 years
AE additional description
|
8.6%
3/35 • up to 3 years
AE additional description
|
|
Eye disorders
Eye pruritus (Study eye)
|
2.2%
2/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Ocular hyperaemia (Study eye)
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
2.9%
1/35 • up to 3 years
AE additional description
|
|
Eye disorders
Ocular hypertension (Study eye)
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
3.4%
2/58 • up to 3 years
AE additional description
|
8.6%
3/35 • up to 3 years
AE additional description
|
|
Eye disorders
Punctate keratitis (Study eye)
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
2.9%
1/35 • up to 3 years
AE additional description
|
|
Eye disorders
Ulcerative keratitis (Study eye)
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
3.4%
2/58 • up to 3 years
AE additional description
|
5.7%
2/35 • up to 3 years
AE additional description
|
|
Eye disorders
Vision blurred (Study eye)
|
2.2%
2/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
5.7%
2/35 • up to 3 years
AE additional description
|
|
Eye disorders
Visual acuity reduced (Contralateral eye)
|
2.2%
2/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
2.9%
1/35 • up to 3 years
AE additional description
|
|
Eye disorders
Visual acuity reduced (Study eye)
|
3.2%
3/93 • up to 3 years
AE additional description
|
3.6%
3/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
2.9%
1/35 • up to 3 years
AE additional description
|
|
General disorders
Asthenia
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
5.2%
3/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
2.9%
1/35 • up to 3 years
AE additional description
|
|
Cardiac disorders
Myocardial ischaemia
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Endocrine disorders
Thyroid mass
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Allergic keratitis (Study eye)
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
2.9%
1/35 • up to 3 years
AE additional description
|
|
Eye disorders
Anterior chamber fibrin (Study eye)
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Blepharitis (Both eyes)
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Blepharitis (Contralateral eye)
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Blepharospasm (Study eye)
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Cataract (Both eyes)
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Cataract (Contralateral eye)
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Cataract subcapsular (Study eye)
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Chalazion (Contralateral eye)
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Choroidal neovascularisation (Contralateral eye)
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Choroiditis (Study eye)
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Conjunctival haemorrhage (Contralateral eye)
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Conjunctival hyperaemia (Both eyes)
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Conjunctival hyperaemia (Study eye)
|
1.1%
1/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Conjunctival ulcer (Study eye)
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
2.9%
1/35 • up to 3 years
AE additional description
|
|
Eye disorders
Conjunctivitis allergic (Both eyes)
|
1.1%
1/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Corneal perforation (Study eye)
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Cystoid macular oedema (Study eye)
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Dry eye (Both eyes)
|
1.1%
1/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Eczema eyelids (Contralateral eye)
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Exophthalmos (Both eyes)
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Eye allergy (Both eyes)
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Eye discharge (Study eye)
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Eye haemorrhage (Study eye)
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
3.4%
2/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Eye inflammation (Study eye)
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
2.9%
1/35 • up to 3 years
AE additional description
|
|
Eye disorders
Eye irritation (Both eyes)
|
2.2%
2/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Eye irritation (Study eye)
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Eye oedema (Study eye)
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
2.9%
1/35 • up to 3 years
AE additional description
|
|
Eye disorders
Eye pain (Both eyes)
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
2.9%
1/35 • up to 3 years
AE additional description
|
|
Eye disorders
Eye pain (Contralateral eye)
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Eye pruritus (Both eyes)
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
2.9%
1/35 • up to 3 years
AE additional description
|
|
Eye disorders
Eye ulcer (Study eye)
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Eyelid cyst (Contralateral eye)
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Eyelid irritation (Study eye)
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Eyelid myoclonus (Study eye)
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Eyelid pain (Study eye)
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Eyelid ptosis (Study eye)
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Foreign body sensation in eyes (Both eyes)
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Foreign body sensation in eyes (Contralateral eye)
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Foreign body sensation in eyes (Study eye)
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
2.9%
1/35 • up to 3 years
AE additional description
|
|
Eye disorders
Glare (Study eye)
|
1.1%
1/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Glaucoma (Both eyes)
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Iridocyclitis (Study eye)
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Iris neovascularisation (Contralateral eye)
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Keratitis (Study eye)
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
2.9%
1/35 • up to 3 years
AE additional description
|
|
Eye disorders
Lacrimation increased (Both eyes)
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
2.9%
1/35 • up to 3 years
AE additional description
|
|
Eye disorders
Macular fibrosis (Study eye)
|
2.2%
2/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Macular oedema (Study eye)
|
1.1%
1/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Metamorphopsia (Study eye)
|
2.2%
2/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Ocular discomfort (Contralateral eye)
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
2.9%
1/35 • up to 3 years
AE additional description
|
|
Eye disorders
Ocular discomfort (Study eye)
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
3.4%
2/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Ocular hypertension (Both eyes)
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Ocular hypertension (Contralateral eye)
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Photophobia (Both eyes)
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Photophobia (Contralateral eye)
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
2.9%
1/35 • up to 3 years
AE additional description
|
|
Eye disorders
Photophobia (Study eye)
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Photopsia (Both eyes)
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Photopsia (Contralateral eye)
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Photopsia (Study eye)
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
2.9%
1/35 • up to 3 years
AE additional description
|
|
Eye disorders
Punctate keratitis (Contralateral eye)
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Retinal detachment (Study eye)
|
1.1%
1/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Retinal haemorrhage (Study eye)
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Retinal neovascularisation (Study eye)
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Retinal oedema (Study eye)
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Retinal pigment epithelial tear (Study eye)
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Retinal pigment epitheliopathy (Both eyes)
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Uveitis (Both eyes)
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Vision blurred (Both eyes)
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
3.4%
2/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Visual acuity reduced (Both eyes)
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
2.9%
1/35 • up to 3 years
AE additional description
|
|
Eye disorders
Visual impairment (Study eye)
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Vitreous floaters (Both eyes)
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Vitreous floaters (Contralateral eye)
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Vitreous floaters (Study eye)
|
1.1%
1/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Eye disorders
Vitreous haemorrhage (Study eye)
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
2.9%
1/35 • up to 3 years
AE additional description
|
|
Eye disorders
Vitritis (Study eye)
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/93 • up to 3 years
AE additional description
|
2.4%
2/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Gastrointestinal disorders
Dental necrosis
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Gastrointestinal disorders
Dyspepsia
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Gastrointestinal disorders
Nausea
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Gastrointestinal disorders
Noninfective gingivitis
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Gastrointestinal disorders
Pancreatitis acute
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Gastrointestinal disorders
Toothache
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
General disorders
Face oedema
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
General disorders
Facial pain
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
General disorders
Feeling hot
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
General disorders
Inflammation
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
2.9%
1/35 • up to 3 years
AE additional description
|
|
General disorders
Influenza like illness
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
General disorders
Injection site ulcer (Study eye)
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
General disorders
Pain
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
General disorders
Pyrexia
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
General disorders
Secretion discharge (Study eye)
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Infections and infestations
Eye infection (Study eye)
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Infections and infestations
Genital infection female
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
2.9%
1/35 • up to 3 years
AE additional description
|
|
Infections and infestations
Herpes zoster
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Infections and infestations
Infected bite
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
2.9%
1/35 • up to 3 years
AE additional description
|
|
Infections and infestations
Lung infection
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
2.9%
1/35 • up to 3 years
AE additional description
|
|
Infections and infestations
Nasopharyngitis
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Infections and infestations
Oral herpes
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Infections and infestations
Post procedural infection (Study eye)
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
2.9%
1/35 • up to 3 years
AE additional description
|
|
Infections and infestations
Rhinitis
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Infections and infestations
Tonsillitis
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Infections and infestations
Tracheitis
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Infections and infestations
Vaginal infection
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Injury, poisoning and procedural complications
Bone fissure
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Injury, poisoning and procedural complications
Conjunctival laceration (Study eye)
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Injury, poisoning and procedural complications
Hyphaema (Study eye)
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
3.4%
2/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Injury, poisoning and procedural complications
Incorrect product storage (Contralateral eye)
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Injury, poisoning and procedural complications
Maternal exposure during pregnancy
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Injury, poisoning and procedural complications
Rib fracture
|
1.1%
1/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Investigations
Blood creatinine increased
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
2.9%
1/35 • up to 3 years
AE additional description
|
|
Investigations
Eosinophil count increased
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Investigations
Intraocular pressure increased (Contralateral eye)
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Investigations
Intraocular pressure increased (Study eye)
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Investigations
Neutrophil count increased
|
0.00%
0/93 • up to 3 years
AE additional description
|
2.4%
2/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Investigations
Red blood cell count increased
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
2.9%
1/35 • up to 3 years
AE additional description
|
|
Investigations
White blood cell count increased
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
2.9%
1/35 • up to 3 years
AE additional description
|
|
Metabolism and nutrition disorders
Folate deficiency
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Metabolism and nutrition disorders
Gout
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Musculoskeletal and connective tissue disorders
Ankylosing spondylitis
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Musculoskeletal and connective tissue disorders
Tendon pain
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma cutis
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Nervous system disorders
Carotid artery stenosis
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Nervous system disorders
Migraine
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Nervous system disorders
Migraine with aura
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Nervous system disorders
Visual field defect (Study eye)
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Psychiatric disorders
Affective disorder
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
2.9%
1/35 • up to 3 years
AE additional description
|
|
Renal and urinary disorders
Microalbuminuria
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
2.9%
1/35 • up to 3 years
AE additional description
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Reproductive system and breast disorders
Amenorrhoea
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
2.9%
1/35 • up to 3 years
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Sinus polyp
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
1.7%
1/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/93 • up to 3 years
AE additional description
|
2.4%
2/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Vascular disorders
Hypotension
|
1.1%
1/93 • up to 3 years
AE additional description
|
0.00%
0/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/93 • up to 3 years
AE additional description
|
1.2%
1/84 • up to 3 years
AE additional description
|
0.00%
0/58 • up to 3 years
AE additional description
|
0.00%
0/35 • up to 3 years
AE additional description
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER