Trial Outcomes & Findings for Efficacy and Safety of Ranibizumab in Two "Treat and Extend" Treatment Algorithms Versus Ranibizumab As Needed in Patients With Macular Edema and Visual Impairment Secondary to Diabetes Mellitus (NCT NCT01171976)
NCT ID: NCT01171976
Last Updated: 2014-09-15
Results Overview
Visual acuity was assessed at every study visit for the study eye using best correction determined from protocol refraction. The BCVA measurements were taken in a sitting position using ETDRS-like VA testing charts at a starting distance of 4 meters.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
373 participants
Primary outcome timeframe
Baseline to Month 12
Results posted on
2014-09-15
Participant Flow
A total of 373 patients with macular edema and visual impairment secondary to DME were enrolled. A total of 372 patients were randomized. One patient was excluded from all analyses due to administrative problems
Antimicrobial eye drops were dispensed at each study visit (PRN ranibizumab) or at visits with scheduled injections (TE ranibizumab + laser or TE ranibizumab alone).
Participant milestones
| Measure |
TE Ranibizumad 0.5 mg and Laser
Patients received an injection ranibizumab and laser therapy.
|
TE Ranibizumab 0.5 mg Alone
Patients received an intravitreal injection ranibizumab
|
PRN Ranibizumab 0.5 mg
Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
|
|---|---|---|---|
|
Overall Study
STARTED
|
121
|
128
|
123
|
|
Overall Study
Safety Set
|
126
|
126
|
118
|
|
Overall Study
COMPLETED
|
107
|
117
|
108
|
|
Overall Study
NOT COMPLETED
|
14
|
11
|
15
|
Reasons for withdrawal
| Measure |
TE Ranibizumad 0.5 mg and Laser
Patients received an injection ranibizumab and laser therapy.
|
TE Ranibizumab 0.5 mg Alone
Patients received an intravitreal injection ranibizumab
|
PRN Ranibizumab 0.5 mg
Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
|
Overall Study
Death
|
2
|
4
|
1
|
|
Overall Study
Lost to Follow-up
|
4
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
5
|
6
|
|
Overall Study
Abnormal test result
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
6
|
2
|
5
|
Baseline Characteristics
Efficacy and Safety of Ranibizumab in Two "Treat and Extend" Treatment Algorithms Versus Ranibizumab As Needed in Patients With Macular Edema and Visual Impairment Secondary to Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
TE Ranibizumad 0.5 mg and Laser
n=121 Participants
Patients received an injection ranibizumab and laser therapy.
|
TE Ranibizumab 0.5 mg Alone
n=128 Participants
Patients received an intravitreal injection ranibizumab
|
PRN Ranibizumab 0.5 mg
n=123 Participants
Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
|
Total
n=372 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63.7 Years
STANDARD_DEVIATION 9.07 • n=99 Participants
|
63.0 Years
STANDARD_DEVIATION 9.83 • n=107 Participants
|
64.5 Years
STANDARD_DEVIATION 9.66 • n=206 Participants
|
63.7 Years
STANDARD_DEVIATION 9.53 • n=7 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
140 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
78 Participants
n=99 Participants
|
77 Participants
n=107 Participants
|
77 Participants
n=206 Participants
|
232 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline to Month 12Population: Analyzed set included all randomized patients who received at least one application of study treatment and had at least one post baseline efficacy assessment. If missing values occurred without a subsequent observed value, the last observed value was carried forward to subsequent scheduled visits by means of a last observation carried forward.
Visual acuity was assessed at every study visit for the study eye using best correction determined from protocol refraction. The BCVA measurements were taken in a sitting position using ETDRS-like VA testing charts at a starting distance of 4 meters.
Outcome measures
| Measure |
TE Ranibizumad 0.5 mg and Laser
n=117 Participants
Patients received an injection ranibizumab and laser therapy.
|
TE Ranibizumab 0.5 mg Alone
n=125 Participants
Patients received an intravitreal injection ranibizumab
|
PRN Ranibizumab 0.5 mg
n=117 Participants
Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
|
|---|---|---|---|
|
Visual Acuity of the Study Eye: Average Change From Baseline to Month 1 Through Month 12
Baseline
|
62.3 Letters
Standard Deviation 11.50
|
64.1 Letters
Standard Deviation 10.52
|
65.1 Letters
Standard Deviation 10.08
|
|
Visual Acuity of the Study Eye: Average Change From Baseline to Month 1 Through Month 12
Average Month 1 to Month 12
|
68.25 Letters
Standard Deviation 11.057
|
70.28 Letters
Standard Deviation 10.284
|
71.32 Letters
Standard Deviation 9.984
|
|
Visual Acuity of the Study Eye: Average Change From Baseline to Month 1 Through Month 12
Average Change from Baseline
|
5.91 Letters
Standard Deviation 5.532
|
6.14 Letters
Standard Deviation 5.717
|
6.20 Letters
Standard Deviation 6.005
|
SECONDARY outcome
Timeframe: Baseline to Month 24Population: Analyzed set included all randomized patients who received at least one application of study treatment and had at least one post baseline efficacy assessment. If missing values occurred without a subsequent observed value, the last observed value was carried forward to subsequent scheduled visits by means of a last observation carried forward.
Visual acuity was assessed at every study visit for the study eye using best correction determined from protocol refraction. The BCVA measurements were taken in a sitting position using ETDRS-like VA testing charts at a starting distance of 4 meters.
Outcome measures
| Measure |
TE Ranibizumad 0.5 mg and Laser
n=117 Participants
Patients received an injection ranibizumab and laser therapy.
|
TE Ranibizumab 0.5 mg Alone
n=125 Participants
Patients received an intravitreal injection ranibizumab
|
PRN Ranibizumab 0.5 mg
n=117 Participants
Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
|
|---|---|---|---|
|
Visual Acuity of the Study Eye: Average Change From Baseline to Month 1 Through Month 24
Average Month 1 to Month 24
|
69.12 Letters
Standard Deviation 11.261
|
70.72 Letters
Standard Deviation 10.924
|
72.09 Letters
Standard Deviation 10.141
|
|
Visual Acuity of the Study Eye: Average Change From Baseline to Month 1 Through Month 24
Baseline
|
62.3 Letters
Standard Deviation 11.50
|
64.1 Letters
Standard Deviation 10.52
|
65.1 Letters
Standard Deviation 10.08
|
|
Visual Acuity of the Study Eye: Average Change From Baseline to Month 1 Through Month 24
Average Change from Baseline
|
6.78 Letters
Standard Deviation 5.986
|
6.58 Letters
Standard Deviation 7.070
|
6.97 Letters
Standard Deviation 6.430
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: Analyzed set included all randomized patients who received at least one application of study treatment and had at least one post baseline efficacy assessment. If missing values occurred without a subsequent observed value, the last observed value was carried forward to subsequent scheduled visits by means of a last observation carried forward.
Visual acuity was assessed at every study visit for the study eye using best correction determined from protocol refraction. The BCVA measurements were taken in a sitting position using ETDRS-like VA testing charts at a starting distance of 4 meters.
Outcome measures
| Measure |
TE Ranibizumad 0.5 mg and Laser
n=117 Participants
Patients received an injection ranibizumab and laser therapy.
|
TE Ranibizumab 0.5 mg Alone
n=125 Participants
Patients received an intravitreal injection ranibizumab
|
PRN Ranibizumab 0.5 mg
n=117 Participants
Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
|
|---|---|---|---|
|
Visual Acuity of the Study Eye: Change From Baseline at Month 12
Baseline
|
62.3 Letters
Standard Deviation 11.50
|
65.1 Letters
Standard Deviation 10.52
|
65.1 Letters
Standard Deviation 10.08
|
|
Visual Acuity of the Study Eye: Change From Baseline at Month 12
Month 12
|
69.13 Letters
Standard Deviation 11.945
|
70.93 Letters
Standard Deviation 11.742
|
72.56 Letters
Standard Deviation 11.592
|
|
Visual Acuity of the Study Eye: Change From Baseline at Month 12
Change from Baseline
|
6.79 Letters
Standard Deviation 6.999
|
6.80 Letters
Standard Deviation 8.726
|
7.44 Letters
Standard Deviation 8.457
|
SECONDARY outcome
Timeframe: Baseline and Month 24Population: Analyzed set included all randomized patients who received at least one application of study treatment and had at least one post baseline efficacy assessment. If missing values occurred without a subsequent observed value, the last observed value was carried forward to subsequent scheduled visits by means of a last observation carried forward.
Visual acuity was assessed at every study visit for the study eye using best correction determined from protocol refraction. The BCVA measurements were taken in a sitting position using ETDRS-like VA testing charts at a starting distance of 4 meters.
Outcome measures
| Measure |
TE Ranibizumad 0.5 mg and Laser
n=117 Participants
Patients received an injection ranibizumab and laser therapy.
|
TE Ranibizumab 0.5 mg Alone
n=125 Participants
Patients received an intravitreal injection ranibizumab
|
PRN Ranibizumab 0.5 mg
n=117 Participants
Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
|
|---|---|---|---|
|
Visual Acuity of the Study Eye: Change From Baseline at Month 24
Baseline
|
62.3 Letters
Standard Deviation 11.50
|
64.1 Letters
Standard Deviation 10.52
|
65.1 Letters
Standard Deviation 10.08
|
|
Visual Acuity of the Study Eye: Change From Baseline at Month 24
Month 24
|
70.64 Letters
Standard Deviation 12.315
|
70.62 Letters
Standard Deviation 13.481
|
73.18 Letters
Standard Deviation 11.872
|
|
Visual Acuity of the Study Eye: Change From Baseline at Month 24
Change from Baseline
|
8.30 Letters
Standard Deviation 8.129
|
6.49 Letters
Standard Deviation 10.854
|
8.06 Letters
Standard Deviation 8.462
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: Analyzed set included all randomized patients who received at least one application of study treatment and had at least one post baseline efficacy assessment. If missing values occurred without a subsequent observed value, the last observed value was carried forward to subsequent scheduled visits by means of a last observation carried forward.
Visual acuity was assessed at every study visit for the study eye using best correction determined from protocol refraction. The BCVA measurements were taken in a sitting position using ETDRS-like VA testing charts at a starting distance of 4 meters.
Outcome measures
| Measure |
TE Ranibizumad 0.5 mg and Laser
n=117 Participants
Patients received an injection ranibizumab and laser therapy.
|
TE Ranibizumab 0.5 mg Alone
n=125 Participants
Patients received an intravitreal injection ranibizumab
|
PRN Ranibizumab 0.5 mg
n=117 Participants
Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
|
|---|---|---|---|
|
Visual Acuity of the Study Eye: Categorized Change From Baseline at Month 12
Gain of >= 1 letter
|
82.9 Percentage of patients
|
84.8 Percentage of patients
|
83.8 Percentage of patients
|
|
Visual Acuity of the Study Eye: Categorized Change From Baseline at Month 12
Gain of >= 5 letters
|
59.0 Percentage of patients
|
60.8 Percentage of patients
|
70.1 Percentage of patients
|
|
Visual Acuity of the Study Eye: Categorized Change From Baseline at Month 12
Gain of >= 10 letters
|
32.5 Percentage of patients
|
42.4 Percentage of patients
|
39.3 Percentage of patients
|
|
Visual Acuity of the Study Eye: Categorized Change From Baseline at Month 12
Gain of >= 15 letters
|
19.7 Percentage of patients
|
30.4 Percentage of patients
|
26.5 Percentage of patients
|
|
Visual Acuity of the Study Eye: Categorized Change From Baseline at Month 12
Loss of >= 5 letters
|
3.4 Percentage of patients
|
4.0 Percentage of patients
|
3.4 Percentage of patients
|
|
Visual Acuity of the Study Eye: Categorized Change From Baseline at Month 12
Loss of >= 10 letters
|
0.0 Percentage of patients
|
2.4 Percentage of patients
|
0.9 Percentage of patients
|
|
Visual Acuity of the Study Eye: Categorized Change From Baseline at Month 12
Loss of >= 15 letters
|
0.0 Percentage of patients
|
1.6 Percentage of patients
|
0.9 Percentage of patients
|
SECONDARY outcome
Timeframe: Baseline, 24 monthPopulation: Analyzed set included all randomized patients who received at least one application of study treatment and had at least one post baseline efficacy assessment. If missing values occurred without a subsequent observed value, the last observed value was carried forward to subsequent scheduled visits by means of a last observation carried forward.
Visual acuity was assessed at every study visit for the study eye using best correction determined from protocol refraction. The BCVA measurements were taken in a sitting position using ETDRS-like VA testing charts at a starting distance of 4 meters.
Outcome measures
| Measure |
TE Ranibizumad 0.5 mg and Laser
n=117 Participants
Patients received an injection ranibizumab and laser therapy.
|
TE Ranibizumab 0.5 mg Alone
n=125 Participants
Patients received an intravitreal injection ranibizumab
|
PRN Ranibizumab 0.5 mg
n=117 Participants
Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
|
|---|---|---|---|
|
Visual Acuity of the Study Eye: Categorized Change From Baseline at Month 24
Loss of >= 15 letters
|
0.9 Percentage of pateints
|
4.0 Percentage of pateints
|
2.6 Percentage of pateints
|
|
Visual Acuity of the Study Eye: Categorized Change From Baseline at Month 24
Gain of >= 1 letter
|
87.2 Percentage of pateints
|
84.0 Percentage of pateints
|
90.6 Percentage of pateints
|
|
Visual Acuity of the Study Eye: Categorized Change From Baseline at Month 24
Gain of >= 5 letters
|
69.2 Percentage of pateints
|
62.4 Percentage of pateints
|
76.1 Percentage of pateints
|
|
Visual Acuity of the Study Eye: Categorized Change From Baseline at Month 24
Gain of >= 10 letters
|
43.6 Percentage of pateints
|
40.8 Percentage of pateints
|
45.3 Percentage of pateints
|
|
Visual Acuity of the Study Eye: Categorized Change From Baseline at Month 24
Gain of >= 15 letters
|
25.6 Percentage of pateints
|
28.0 Percentage of pateints
|
30.8 Percentage of pateints
|
|
Visual Acuity of the Study Eye: Categorized Change From Baseline at Month 24
Loss of >= 5 letters
|
4.3 Percentage of pateints
|
8.0 Percentage of pateints
|
5.1 Percentage of pateints
|
|
Visual Acuity of the Study Eye: Categorized Change From Baseline at Month 24
Loss of >= 10 letters
|
2.6 Percentage of pateints
|
7.2 Percentage of pateints
|
3.4 Percentage of pateints
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: Analyzed set included all randomized patients who received at least one application of study treatment and had at least one post baseline efficacy assessment. If missing values occurred without a subsequent observed value, the last observed value was carried forward to subsequent scheduled visits by means of a last observation carried forward.
High Resolution OCT was performed at every study visit by Spectral Domain OCT (if not available Time Domain OCT was acceptable) and the images were transferred to a digital video disc. These assessments were performed by trained and adequately qualified experts at the sites and prior to any study drug administration. CSFT is the average retinal thickness of the circular area with 1 mm diameter around the foveal center.
Outcome measures
| Measure |
TE Ranibizumad 0.5 mg and Laser
n=117 Participants
Patients received an injection ranibizumab and laser therapy.
|
TE Ranibizumab 0.5 mg Alone
n=125 Participants
Patients received an intravitreal injection ranibizumab
|
PRN Ranibizumab 0.5 mg
n=117 Participants
Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
|
|---|---|---|---|
|
Central Subfield Thickness of the Study Eye: Percent Change From Baseline at Month 12
|
-27.09 Percent Change
Standard Deviation 22.992
|
-24.35 Percent Change
Standard Deviation 22.027
|
-23.16 Percent Change
Standard Deviation 22.362
|
SECONDARY outcome
Timeframe: Baseline and 24 monthPopulation: Analyzed set included all randomized patients who received at least one application of study treatment and had at least one post baseline efficacy assessment. If missing values occurred without a subsequent observed value, the last observed value was carried forward to subsequent scheduled visits by means of a last observation carried forward.
High Resolution OCT was performed at every study visit by Spectral Domain OCT (if not available Time Domain OCT was acceptable) and the images were transferred to a digital video disc. These assessments were performed by trained and adequately qualified experts at the sites and prior to any study drug administration. CSFT is the average retinal thickness of the circular area with 1 mm diameter around the foveal center.
Outcome measures
| Measure |
TE Ranibizumad 0.5 mg and Laser
n=117 Participants
Patients received an injection ranibizumab and laser therapy.
|
TE Ranibizumab 0.5 mg Alone
n=125 Participants
Patients received an intravitreal injection ranibizumab
|
PRN Ranibizumab 0.5 mg
n=117 Participants
Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
|
|---|---|---|---|
|
Central Subfield Thickness of the Study Eye: Percent Change From Baseline at Month 24
|
-32.03 Percent Change
Standard Deviation 25.628
|
-24.98 Percent Change
Standard Deviation 26.414
|
-24.97 Percent Change
Standard Deviation 26.678
|
SECONDARY outcome
Timeframe: Baseline, Month 12 and Month 24Population: Analyzed set included all randomized patients who received at least one application of study treatment and had at least one post baseline efficacy assessment. If missing values occurred without a subsequent observed value, the last observed value was carried forward to subsequent scheduled visits by means of a last observation carried forward.
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) was used to measure the influence of visual disability and symptoms on general health. The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. For each, the patient was asked to rate their condition on a scale of 1-5 or 1-6, where a low number reflects a better outcome. Each response was recoded per the scoring rules outlined in the National Eye Institute (NEI) VFQ-25 Scoring Algorithm. Under this scoring algorithm , the recoded values range between 0 and 100 and a high score means a better functioning
Outcome measures
| Measure |
TE Ranibizumad 0.5 mg and Laser
n=117 Participants
Patients received an injection ranibizumab and laser therapy.
|
TE Ranibizumab 0.5 mg Alone
n=125 Participants
Patients received an intravitreal injection ranibizumab
|
PRN Ranibizumab 0.5 mg
n=117 Participants
Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
|
|---|---|---|---|
|
Visual Functioning Questionnaire (VFQ-25) Change From Baseline in Total Score at Month 12 and Month 24
Change from baseline at Month 12 (n=116,122,114)
|
4.60 Score on a scale
Standard Deviation 10.905
|
3.95 Score on a scale
Standard Deviation 10.941
|
5.41 Score on a scale
Standard Deviation 12.063
|
|
Visual Functioning Questionnaire (VFQ-25) Change From Baseline in Total Score at Month 12 and Month 24
Baseline (n=116,122,114)
|
75.32 Score on a scale
Standard Deviation 17.317
|
75.47 Score on a scale
Standard Deviation 17.105
|
77.07 Score on a scale
Standard Deviation 18.581
|
|
Visual Functioning Questionnaire (VFQ-25) Change From Baseline in Total Score at Month 12 and Month 24
Change from baseline at month 24 (n=116,122,114)
|
4.06 Score on a scale
Standard Deviation 11.859
|
2.31 Score on a scale
Standard Deviation 13.270
|
5.96 Score on a scale
Standard Deviation 12.389
|
SECONDARY outcome
Timeframe: Baseline, Month 12 and Month 24Population: Analyzed set included all randomized patients who received at least one application of study treatment and had at least one post baseline efficacy assessment. If missing values occurred without a subsequent observed value, the last observed value was carried forward to subsequent scheduled visits by means of a last observation carried forward.
The Euro Quality of Life Questionnaire (EQ-5D) is an indirect utility questionnaire. It is a standardized instrument was utilized to measure health outcomes related to 5 dimensions, namely: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The possible range for each dimension was 1 to 3, where 1= "no problems", 2="some problems" and 3="extreme problems" . A composite health index was then defined by combining the levels for each dimension. Overall, 243 health states are possible. For each health state, the EuroQol group has assigned a utility value typically between 0 and 1 with lower scores representing a higher level of dysfunction
Outcome measures
| Measure |
TE Ranibizumad 0.5 mg and Laser
n=117 Participants
Patients received an injection ranibizumab and laser therapy.
|
TE Ranibizumab 0.5 mg Alone
n=125 Participants
Patients received an intravitreal injection ranibizumab
|
PRN Ranibizumab 0.5 mg
n=117 Participants
Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
|
|---|---|---|---|
|
EuroQoL (EQ-5D) Thermometer Score: Change From Baseline at Month 12 and Month 24
Change from Baseline at Month 24 (n=115,123,113)
|
1.35 Score on a scale
Standard Deviation 17.464
|
0.11 Score on a scale
Standard Deviation 14.755
|
1.98 Score on a scale
Standard Deviation 14.812
|
|
EuroQoL (EQ-5D) Thermometer Score: Change From Baseline at Month 12 and Month 24
Baseline
|
71.4 Score on a scale
Standard Deviation 17.36 • Interval -2.18 to 2.69
|
70.7 Score on a scale
Standard Deviation 16.10 • Interval -1.83 to 2.85
|
72.2 Score on a scale
Standard Deviation 13.24 • Interval 0.25 to 5.1
|
|
EuroQoL (EQ-5D) Thermometer Score: Change From Baseline at Month 12 and Month 24
Change from Baseline at Month 12 (n=115,123,113)
|
0.47 Score on a scale
Standard Deviation 16.487 • Interval -1.11 to 4.0
|
0.91 Score on a scale
Standard Deviation 13.422 • Interval -2.56 to 2.35
|
2.52 Score on a scale
Standard Deviation 14.431 • Interval -0.11 to 4.97
|
Adverse Events
TE Ranibizumab 0.5 mg and Laser
Serious events: 34 serious events
Other events: 98 other events
Deaths: 0 deaths
TE Ranibizumab 0.5 mg Alone
Serious events: 29 serious events
Other events: 101 other events
Deaths: 0 deaths
PRN Ranibizumab 0.5 mg
Serious events: 26 serious events
Other events: 78 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TE Ranibizumab 0.5 mg and Laser
n=126 participants at risk
Patients received an injection ranibizumab and laser therapy.
|
TE Ranibizumab 0.5 mg Alone
n=126 participants at risk
Patients received an intravitreal injection ranibizumab
|
PRN Ranibizumab 0.5 mg
n=118 participants at risk
Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Blood and lymphatic system disorders
Hypocoagulable state
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Cardiac disorders
Angina pectoris
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Cardiac disorders
Bradycardia
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Cardiac disorders
Cardiac failure
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Cardiac disorders
Cardiac failure acute
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Cardiac disorders
Cardiovascular disorder
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Cardiac disorders
Myocardial infarction
|
3.2%
4/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Congenital, familial and genetic disorders
Hypertrophic cardiomyopathy
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Ear and labyrinth disorders
Meniere's disease
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Eye disorders
Cataract (Fellow eye)
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Eye disorders
Macular fibrosis (Treated non-study eye)
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Eye disorders
Vitreous adhesions (Treated non-study eye)
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Eye disorders
Vitreous haemorrhage (Study eye)
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Duodenitis
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Small intestine ulcer
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Tooth loss
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
General disorders
Chest pain
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
General disorders
Malaise
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
General disorders
Oedema peripheral
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Hepatobiliary disorders
Gallbladder perforation
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Bacterascites
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Cellulitis
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Diabetic gangrene
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Endophthalmitis (Study eye)
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Endophthalmitis (Treated non-study eye)
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Orchitis
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Pneumonia
|
2.4%
3/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Renal abscess
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Wound infection
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Periorbital haematoma (Study eye)
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Investigations
Blood glucose increased
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Investigations
Blood urine present
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Investigations
International normalised ratio increased
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Ketoacidosis
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to soft tissue
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.7%
2/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
Cerebral infarction
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
2.5%
3/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
Hypertensive encephalopathy
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
Myelopathy
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Renal and urinary disorders
Renal failure
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Renal and urinary disorders
Renal mass
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Vascular disorders
Arterial occlusive disease
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Vascular disorders
Arteriosclerosis
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Vascular disorders
Diabetic macroangiopathy
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Vascular disorders
Diabetic vascular disorder
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Vascular disorders
Haematoma
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Vascular disorders
Hypertension
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Vascular disorders
Hypotension
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
Other adverse events
| Measure |
TE Ranibizumab 0.5 mg and Laser
n=126 participants at risk
Patients received an injection ranibizumab and laser therapy.
|
TE Ranibizumab 0.5 mg Alone
n=126 participants at risk
Patients received an intravitreal injection ranibizumab
|
PRN Ranibizumab 0.5 mg
n=118 participants at risk
Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.2%
4/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
4.0%
5/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
3.4%
4/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.7%
2/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Cardiac disorders
Cardiovascular insufficiency
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.7%
2/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Ear and labyrinth disorders
Vertigo
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
3.4%
4/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Eye disorders
Blepharitis (Study eye)
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Eye disorders
Blindness transient (Study eye)
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Eye disorders
Cataract (Fellow eye)
|
2.4%
3/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
3.2%
4/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.7%
2/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Eye disorders
Cataract (Study eye)
|
4.0%
5/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
5.6%
7/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
5.9%
7/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Eye disorders
Cataract (Treated non-study eye)
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
2.4%
3/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Eye disorders
Cataract subcapsular (Study eye)
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Eye disorders
Conjunctival haemorrhage (Study eye)
|
4.0%
5/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
8.7%
11/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
5.1%
6/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Eye disorders
Conjunctival haemorrhage (Treated non-study eye)
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Eye disorders
Conjunctivitis (Study eye)
|
4.8%
6/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Eye disorders
Corneal disorder (Study eye)
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Eye disorders
Diabetic retinal oedema (Fellow eye)
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
2.5%
3/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Eye disorders
Diabetic retinal oedema (Study eye)
|
3.2%
4/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Eye disorders
Diabetic retinal oedema (Treated non-study eye)
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
2.5%
3/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Eye disorders
Diabetic retinopathy (Fellow eye)
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
2.5%
3/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Eye disorders
Dry eye (Fellow eye)
|
2.4%
3/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
2.5%
3/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Eye disorders
Dry eye (Study eye)
|
4.8%
6/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
2.4%
3/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
3.4%
4/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Eye disorders
Dry eye (Treated non-study eye)
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Eye disorders
Eye haemorrhage (Treated non-study eye)
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Eye disorders
Eye irritation (Study eye)
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
3.2%
4/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.7%
2/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Eye disorders
Eye pain (Fellow eye)
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.7%
2/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Eye disorders
Eye pain (Study eye)
|
6.3%
8/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
5.6%
7/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
2.5%
3/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Eye disorders
Eye pain (Treated non-study eye)
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.7%
2/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Eye disorders
Eye pruritus (Fellow eye)
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
2.5%
3/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Eye disorders
Eye pruritus (Study eye)
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.7%
2/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Eye disorders
Eye pruritus (Treated non-study eye)
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Eye disorders
Eyelid oedema (Fellow eye)
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Eye disorders
Eyelid oedema (Study eye)
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.7%
2/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Eye disorders
Foreign body sensation in eyes (Study eye)
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Eye disorders
Glaucoma (Study eye)
|
2.4%
3/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Eye disorders
Keratitis (Study eye)
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
2.4%
3/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Eye disorders
Lacrimation increased (Study eye)
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
3.2%
4/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Eye disorders
Macular fibrosis (Fellow eye)
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Eye disorders
Macular fibrosis (Study eye)
|
2.4%
3/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Eye disorders
Macular fibrosis (Treated non-study eye)
|
2.4%
3/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.7%
2/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Eye disorders
Macular oedema (Fellow eye)
|
2.4%
3/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
4.8%
6/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
2.5%
3/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Eye disorders
Macular oedema (Study eye)
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
2.4%
3/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.7%
2/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Eye disorders
Macular oedema (Treated non-study eye)
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
2.4%
3/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Eye disorders
Ocular hyperaemia (Study eye)
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Eye disorders
Ocular hypertension (Fellow eye)
|
2.4%
3/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.7%
2/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Eye disorders
Ocular hypertension (Study eye)
|
5.6%
7/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
2.5%
3/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Eye disorders
Posterior capsule opacification (Fellow eye)
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.7%
2/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Eye disorders
Punctate keratitis (Study eye)
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.7%
2/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Eye disorders
Retinal exudates (Fellow eye)
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.7%
2/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Eye disorders
Retinal exudates (Study eye)
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.7%
2/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Eye disorders
Retinal haemorrhage (Study eye)
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
2.4%
3/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Eye disorders
Retinal haemorrhage (Treated non-study eye)
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Eye disorders
Retinal neovascularisation (Fellow eye)
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
3.2%
4/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
2.5%
3/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Eye disorders
Retinal vascular disorder (Study eye)
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Eye disorders
Retinal vascular disorder (Treated non-study eye)
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Eye disorders
Visual acuity reduced (Study eye)
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.7%
2/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Eye disorders
Visual impairment (Study eye)
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.7%
2/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Eye disorders
Vitreous floaters (Study eye)
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
3.4%
4/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Eye disorders
Vitreous haemorrhage (Fellow eye)
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
3.2%
4/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Eye disorders
Vitreous haemorrhage (Study eye)
|
6.3%
8/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Constipation
|
2.4%
3/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.2%
4/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
3.2%
4/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
5.9%
7/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.7%
2/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Nausea
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
2.5%
3/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Vomiting
|
2.4%
3/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
3.2%
4/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
2.5%
3/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
General disorders
Fatigue
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.7%
2/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
General disorders
General physical health deterioration
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
General disorders
Influenza like illness
|
2.4%
3/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
General disorders
Malaise
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.7%
2/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
General disorders
Oedema peripheral
|
5.6%
7/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
4.0%
5/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
2.5%
3/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
General disorders
Pain
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
General disorders
Pyrexia
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
2.4%
3/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
2.5%
3/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Bronchitis
|
8.7%
11/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
4.2%
5/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
4.0%
5/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Conjunctivitis viral (Study eye)
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Cystitis
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
5.1%
6/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Ear infection
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
2.5%
3/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Gastroenteritis
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Gastroenteritis viral
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
2.4%
3/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Hordeolum (Study eye)
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Influenza
|
7.1%
9/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
7.9%
10/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
6.8%
8/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.7%
2/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Localised infection
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Lower respiratory tract infection
|
2.4%
3/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
2.4%
3/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
2.5%
3/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Nasopharyngitis
|
8.7%
11/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
7.9%
10/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
6.8%
8/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Paronychia
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Pneumonia
|
2.4%
3/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Respiratory tract infection
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
2.4%
3/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Skin infection
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
2.4%
3/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.7%
2/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Tooth infection
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.7%
2/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.4%
3/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
4.0%
5/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
3.4%
4/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Urinary tract infection
|
7.1%
9/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
7.9%
10/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
4.2%
5/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Viral infection
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.7%
2/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Fall
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Laceration
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
2.4%
3/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.7%
2/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Investigations
Alanine aminotransferase increased
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Investigations
Aspartate aminotransferase increased
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.7%
2/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
3.4%
4/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Investigations
Blood creatinine increased
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
3.2%
4/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Investigations
Blood glucose increased
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
2.4%
3/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
2.5%
3/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
3.2%
4/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
2.5%
3/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Investigations
Blood potassium increased
|
2.4%
3/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
3.2%
4/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.7%
2/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Investigations
Blood urea increased
|
2.4%
3/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
3.2%
4/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.7%
2/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Investigations
Blood uric acid increased
|
2.4%
3/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Investigations
Blood urine present
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
2.4%
3/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
3.4%
4/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Investigations
Gamma-glutamyltransferase increased
|
2.4%
3/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
4.8%
6/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
3.4%
4/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Investigations
Glycosylated haemoglobin increased
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.7%
2/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Investigations
Haematocrit decreased
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Investigations
Haemoglobin decreased
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
3.2%
4/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Investigations
Intraocular pressure increased (Fellow eye)
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Investigations
Intraocular pressure increased (Study eye)
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
5.6%
7/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
4.2%
5/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Investigations
Platelet count decreased
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
2.5%
3/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Investigations
Protein total increased
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.7%
2/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Investigations
Red blood cell count decreased
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Investigations
White blood cell count increased
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
4.0%
5/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
2.4%
3/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
3.4%
4/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
2.4%
3/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
3.2%
4/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
3.4%
4/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Gout
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
2.5%
3/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
2.4%
3/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
2.5%
3/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
4.8%
6/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.7%
2/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.7%
2/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
4.0%
5/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
3.2%
4/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Ketosis
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.7%
2/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.7%
2/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
3.2%
4/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
3.2%
4/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
3.2%
4/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.3%
8/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
7.9%
10/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
2.5%
3/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.4%
3/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
3.4%
4/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.4%
3/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
2.5%
3/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.7%
2/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
Diabetic neuropathy
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
Dizziness
|
3.2%
4/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.7%
2/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
Headache
|
3.2%
4/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
3.4%
4/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
Hypoglycaemic coma
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.7%
2/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.7%
2/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
Sciatica
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.7%
2/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
Syncope
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.7%
2/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Psychiatric disorders
Depression
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
2.5%
3/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Psychiatric disorders
Insomnia
|
3.2%
4/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Renal and urinary disorders
Renal failure
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Renal and urinary disorders
Renal impairment
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.7%
2/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.0%
5/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
3.2%
4/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
3.4%
4/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.7%
2/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
2.4%
3/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.7%
2/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Vascular disorders
Hypertension
|
15.1%
19/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
13.5%
17/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
6.8%
8/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Vascular disorders
Hypotension
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.00%
0/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
|
Vascular disorders
Venous insufficiency
|
1.6%
2/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.79%
1/126
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
0.85%
1/118
The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
|
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 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