Trial Outcomes & Findings for Multicenter 12 Months Clinical Study to Evaluate Efficacy and Safety of Ranibizumab Alone or in Combination With Laser Photocoagulation vs. Laser Photocoagulation Alone in Proliferative Diabetic Retinopathy (PRIDE) (NCT NCT01594281)
NCT ID: NCT01594281
Last Updated: 2019-03-15
Results Overview
The area of neovascularizations (NV) was assessed by a central reading center via fluorescein angiography (FA) images. The area of NV was calculated as the sum of area of neovascularization of the disc (NVD) and neovascularization elsewhere (NVE) and was recorded in square millimeters. A higher positive change value may indicate a greater formation of new, abnormal blood vessels and thus disease progression. One eye (study eye) contributed to the analysis.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
107 participants
Primary outcome timeframe
Baseline, EOCS
Results posted on
2019-03-15
Participant Flow
Patients were screened for eligibility at 23 German study sites and randomized at 22 of the 23 sites.
The number of patients in the protocol section (107) excludes one patient in the Ranibizumab mono arm who withdrew prior to the baseline visit. The number of patients in the Randomized Set (108) includes this patient. A separate Informed Consent was signed for the Non-Interventional Follow Up Phase
Participant milestones
| Measure |
Ranibizumab Mono
Interventional Core Phase: One intravitreal injection of ranibizumab 0.5 mg to the study eye monthly until stability regarding morphological parameters is confirmed (ie, no further improvement of morphology or no worsening of morphology for 3 consecutive months)
Non-interventional Follow-Up Phase: Treatment per physician´s routine standard of care until Month 24
|
PRP Mono
Interventional Core Phase: Panretinal laser photocoagulation (PRP) treatment administered to the study eye in accordance with the modified diabetic retinopathy study (DRS) guidelines for panretinal laser photocoagulation procedures. If stability of morphological parameters could not be confirmed after 3 months, additional laser treatment was initiated.
Non-Interventional Follow-Up Phase: Treatment per physician´s routine standard of care until Month 24.
|
Ranibizumab+PRP
Interventional Core Phase: Ranibizumab 0.5 mg as described for the ranibizumab mono arm and PRP treatment as described for the PRP mono arm until stability regarding morphological parameters is confirmed
Non-interventional Follow-Up Phase: Treatment per physician´s routine standard of care until Month 24
|
|---|---|---|---|
|
Interventional Core Phase
STARTED
|
36
|
36
|
36
|
|
Interventional Core Phase
Full Analysis Set (FAS)
|
35
|
35
|
36
|
|
Interventional Core Phase
COMPLETED
|
29
|
26
|
28
|
|
Interventional Core Phase
NOT COMPLETED
|
7
|
10
|
8
|
|
Non-Interventional Follow Up Phase
STARTED
|
28
|
21
|
25
|
|
Non-Interventional Follow Up Phase
Follow Up Set (FUS)
|
28
|
20
|
25
|
|
Non-Interventional Follow Up Phase
COMPLETED
|
25
|
19
|
23
|
|
Non-Interventional Follow Up Phase
NOT COMPLETED
|
3
|
2
|
2
|
Reasons for withdrawal
| Measure |
Ranibizumab Mono
Interventional Core Phase: One intravitreal injection of ranibizumab 0.5 mg to the study eye monthly until stability regarding morphological parameters is confirmed (ie, no further improvement of morphology or no worsening of morphology for 3 consecutive months)
Non-interventional Follow-Up Phase: Treatment per physician´s routine standard of care until Month 24
|
PRP Mono
Interventional Core Phase: Panretinal laser photocoagulation (PRP) treatment administered to the study eye in accordance with the modified diabetic retinopathy study (DRS) guidelines for panretinal laser photocoagulation procedures. If stability of morphological parameters could not be confirmed after 3 months, additional laser treatment was initiated.
Non-Interventional Follow-Up Phase: Treatment per physician´s routine standard of care until Month 24.
|
Ranibizumab+PRP
Interventional Core Phase: Ranibizumab 0.5 mg as described for the ranibizumab mono arm and PRP treatment as described for the PRP mono arm until stability regarding morphological parameters is confirmed
Non-interventional Follow-Up Phase: Treatment per physician´s routine standard of care until Month 24
|
|---|---|---|---|
|
Interventional Core Phase
Protocol Deviation
|
1
|
0
|
0
|
|
Interventional Core Phase
Subject Withdrew Consent
|
0
|
1
|
1
|
|
Interventional Core Phase
Death
|
1
|
1
|
2
|
|
Interventional Core Phase
Lost to Follow-up
|
1
|
4
|
1
|
|
Interventional Core Phase
Adverse Event
|
4
|
4
|
4
|
|
Non-Interventional Follow Up Phase
Lost to Follow-up
|
2
|
2
|
0
|
|
Non-Interventional Follow Up Phase
Administrative Problems
|
0
|
0
|
1
|
|
Non-Interventional Follow Up Phase
Subject Withdrew Consent
|
1
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Ranibizumab Mono
n=35 Participants
Interventional Core Phase: One intravitreal injection of ranibizumab 0.5 mg to the study eye monthly until stability regarding morphological parameters is confirmed (ie, no further improvement of morphology or no worsening of morphology for 3 consecutive months)
Non-interventional Follow-Up Phase: Treatment per physician´s routine standard of care until Month 24
|
PRP Mono
n=35 Participants
Interventional Core Phase: Panretinal laser photocoagulation (PRP) treatment administered to the study eye in accordance with the modified diabetic retinopathy study (DRS) guidelines for panretinal laser photocoagulation procedures. If stability of morphological parameters could not be confirmed after 3 months, additional laser treatment was initiated.
Non-Interventional Follow-Up Phase: Treatment per physician´s routine standard of care until Month 24.
|
Ranibizumab+PRP
n=36 Participants
Interventional Core Phase: Ranibizumab 0.5 mg as described for the ranibizumab mono arm and PRP treatment as described for the PRP mono arm until stability regarding morphological parameters is confirmed
Non-interventional Follow-Up Phase: Treatment per physician´s routine standard of care until Month 24
|
Total
n=106 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
52.5 Years
STANDARD_DEVIATION 11.0 • n=35 Participants
|
53.0 Years
STANDARD_DEVIATION 12.1 • n=35 Participants
|
55.0 Years
STANDARD_DEVIATION 13.4 • n=36 Participants
|
53.5 Years
STANDARD_DEVIATION 12.1 • n=106 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=35 Participants
|
11 Participants
n=35 Participants
|
8 Participants
n=36 Participants
|
33 Participants
n=106 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=35 Participants
|
24 Participants
n=35 Participants
|
28 Participants
n=36 Participants
|
73 Participants
n=106 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Baseline, EOCSPopulation: FAS; LOCF. Only patients with both values at baseline and any post-baseline value were included.
The area of neovascularizations (NV) was assessed by a central reading center via fluorescein angiography (FA) images. The area of NV was calculated as the sum of area of neovascularization of the disc (NVD) and neovascularization elsewhere (NVE) and was recorded in square millimeters. A higher positive change value may indicate a greater formation of new, abnormal blood vessels and thus disease progression. One eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
Ranibizumab Mono
n=33 Participants
Interventional Core Phase: One intravitreal injection of ranibizumab 0.5 mg to the study eye monthly until stability regarding morphological parameters is confirmed (ie, no further improvement of morphology or no worsening of morphology for 3 consecutive months)
|
PRP Mono
n=33 Participants
Interventional Core Phase: Panretinal laser photocoagulation (PRP) treatment administered to the study eye in accordance with the modified diabetic retinopathy study (DRS) guidelines for panretinal laser photocoagulation procedures
|
Ranibizumab+PRP
n=33 Participants
Interventional Core Phase: Ranibizumab 0.5 mg as described for the ranibizumab mono arm and PRP treatment as described for the PRP mono arm until stability regarding morphological parameters is confirmed
|
|---|---|---|---|
|
Change From Baseline in Area of Neovascularizations (NVs) at End of Core Study (EOCS)
|
-4.6 square millimeters
Standard Deviation 11.3
|
-0.9 square millimeters
Standard Deviation 3.9
|
-1.7 square millimeters
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: FAS; LOCF. Only patients with both values at baseline and any post-baseline value were included.
The area of neovascularizations (NV) was assessed by a central reading center via fluorescein angiography (FA) images. The area of NV was calculated as the sum of area of neovascularization of the disc (NVD) and neovascularization elsewhere (NVE) and was recorded in square millimeters. A higher positive change value may indicate a greater formation of new, abnormal blood vessels and thus disease progression. One eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
Ranibizumab Mono
n=33 Participants
Interventional Core Phase: One intravitreal injection of ranibizumab 0.5 mg to the study eye monthly until stability regarding morphological parameters is confirmed (ie, no further improvement of morphology or no worsening of morphology for 3 consecutive months)
|
PRP Mono
n=32 Participants
Interventional Core Phase: Panretinal laser photocoagulation (PRP) treatment administered to the study eye in accordance with the modified diabetic retinopathy study (DRS) guidelines for panretinal laser photocoagulation procedures
|
Ranibizumab+PRP
n=33 Participants
Interventional Core Phase: Ranibizumab 0.5 mg as described for the ranibizumab mono arm and PRP treatment as described for the PRP mono arm until stability regarding morphological parameters is confirmed
|
|---|---|---|---|
|
Change From Baseline in Area of Neovascularizations (NVs) at Month 3
|
-5.9 square millimeters
Standard Deviation 12.7
|
-0.7 square millimeters
Standard Deviation 2.8
|
-2.7 square millimeters
Standard Deviation 3.9
|
SECONDARY outcome
Timeframe: EOCSPopulation: FAS; LOCF
BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at a testing distance of 4 meters. A higher number of ETDRS letters may indicate better visual acuity. One eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
Ranibizumab Mono
n=35 Participants
Interventional Core Phase: One intravitreal injection of ranibizumab 0.5 mg to the study eye monthly until stability regarding morphological parameters is confirmed (ie, no further improvement of morphology or no worsening of morphology for 3 consecutive months)
|
PRP Mono
n=35 Participants
Interventional Core Phase: Panretinal laser photocoagulation (PRP) treatment administered to the study eye in accordance with the modified diabetic retinopathy study (DRS) guidelines for panretinal laser photocoagulation procedures
|
Ranibizumab+PRP
n=36 Participants
Interventional Core Phase: Ranibizumab 0.5 mg as described for the ranibizumab mono arm and PRP treatment as described for the PRP mono arm until stability regarding morphological parameters is confirmed
|
|---|---|---|---|
|
Best Corrected Visual Acuity (BCVA) (ETDRS Letters) at EOCS
|
84.4 letters
Standard Deviation 8.6
|
76.8 letters
Standard Deviation 17.0
|
78.9 letters
Standard Deviation 12.2
|
SECONDARY outcome
Timeframe: Baseline, EOCSPopulation: FAS; LOCF
BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at a testing distance of 4 meters. No clinically relevant change was defined as \<5 letters gain or loss. A higher positive change value may indicate a greater improvement in visual acuity. One eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
Ranibizumab Mono
n=35 Participants
Interventional Core Phase: One intravitreal injection of ranibizumab 0.5 mg to the study eye monthly until stability regarding morphological parameters is confirmed (ie, no further improvement of morphology or no worsening of morphology for 3 consecutive months)
|
PRP Mono
n=35 Participants
Interventional Core Phase: Panretinal laser photocoagulation (PRP) treatment administered to the study eye in accordance with the modified diabetic retinopathy study (DRS) guidelines for panretinal laser photocoagulation procedures
|
Ranibizumab+PRP
n=36 Participants
Interventional Core Phase: Ranibizumab 0.5 mg as described for the ranibizumab mono arm and PRP treatment as described for the PRP mono arm until stability regarding morphological parameters is confirmed
|
|---|---|---|---|
|
Percentage of Patients With Change From Baseline in BCVA (ETDRS Letters) at EOCS
≥5 letters loss from Baseline at EOCS
|
17.1 percentage of participants
|
37.1 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Patients With Change From Baseline in BCVA (ETDRS Letters) at EOCS
≥15 letters gain from Baseline at EOCS
|
0.0 percentage of participants
|
2.9 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Patients With Change From Baseline in BCVA (ETDRS Letters) at EOCS
≥10 letters gain from Baseline at EOCS
|
5.7 percentage of participants
|
11.4 percentage of participants
|
8.3 percentage of participants
|
|
Percentage of Patients With Change From Baseline in BCVA (ETDRS Letters) at EOCS
≥5 letters gain from Baseline at EOCS
|
31.4 percentage of participants
|
20.0 percentage of participants
|
13.9 percentage of participants
|
|
Percentage of Patients With Change From Baseline in BCVA (ETDRS Letters) at EOCS
No clinically relevant change from Baseline
|
51.4 percentage of participants
|
42.9 percentage of participants
|
61.1 percentage of participants
|
|
Percentage of Patients With Change From Baseline in BCVA (ETDRS Letters) at EOCS
≥10 letters loss from Baseline at EOCS
|
11.4 percentage of participants
|
11.4 percentage of participants
|
8.3 percentage of participants
|
|
Percentage of Patients With Change From Baseline in BCVA (ETDRS Letters) at EOCS
≥15 letters loss from Baseline at EOCS
|
2.9 percentage of participants
|
8.6 percentage of participants
|
2.8 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, EOCSPopulation: FAS. Only patients with both values at baseline and any post-baseline value were included.
The severity level of diabetic retinopathy was determined using the ETDRS severity scale. However, in contrast to the original ETDRS severity scale, wide field fluorescein angiography images were used in addition to color fundus photography for identification of NVs and prior PRP treatment was not considered for determining the severity level. Eyes could be graded in the following classes: "DR absent" (10), "questionable DR" (14,15), "NPDR" (20-53), "mild PDR" (60-61), "moderate PDR" (65), "high risk PDR" (71-75), "advanced PDR" (81-85) and "cannot grade" (90). One eye (study eye) contributed to the analysis. No statistical analysis was conducted for ≥ 1 class deterioration or ≥ 2 class deterioration from Baseline at EOCS because ratios could not be calculated in case of zero frequencies in at least one of the three treatment groups.
Outcome measures
| Measure |
Ranibizumab Mono
n=29 Participants
Interventional Core Phase: One intravitreal injection of ranibizumab 0.5 mg to the study eye monthly until stability regarding morphological parameters is confirmed (ie, no further improvement of morphology or no worsening of morphology for 3 consecutive months)
|
PRP Mono
n=26 Participants
Interventional Core Phase: Panretinal laser photocoagulation (PRP) treatment administered to the study eye in accordance with the modified diabetic retinopathy study (DRS) guidelines for panretinal laser photocoagulation procedures
|
Ranibizumab+PRP
n=28 Participants
Interventional Core Phase: Ranibizumab 0.5 mg as described for the ranibizumab mono arm and PRP treatment as described for the PRP mono arm until stability regarding morphological parameters is confirmed
|
|---|---|---|---|
|
Number of Patients With Change From Baseline in ETDRS Severity Grade of Diabetic Retinopathy (DR) at EOCS
≥ 1 class improvement from Baseline at EOCS
|
10 participants
|
9 participants
|
13 participants
|
|
Number of Patients With Change From Baseline in ETDRS Severity Grade of Diabetic Retinopathy (DR) at EOCS
≥ 2 class improvement from Baseline at EOCS
|
2 participants
|
2 participants
|
5 participants
|
|
Number of Patients With Change From Baseline in ETDRS Severity Grade of Diabetic Retinopathy (DR) at EOCS
≥ 1 class deterioration from Baseline at EOCS
|
2 participants
|
0 participants
|
1 participants
|
|
Number of Patients With Change From Baseline in ETDRS Severity Grade of Diabetic Retinopathy (DR) at EOCS
≥ 2 class deterioration from Baseline at EOCS
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline, EOCSPopulation: FAS; LOCF. Only patients with both values at baseline and any post-baseline value were included.
Central subfield retinal thickness was assessed by a central reading center using Optical Coherence Tomography images. A positive change value may indicate disease progression. One eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
Ranibizumab Mono
n=32 Participants
Interventional Core Phase: One intravitreal injection of ranibizumab 0.5 mg to the study eye monthly until stability regarding morphological parameters is confirmed (ie, no further improvement of morphology or no worsening of morphology for 3 consecutive months)
|
PRP Mono
n=31 Participants
Interventional Core Phase: Panretinal laser photocoagulation (PRP) treatment administered to the study eye in accordance with the modified diabetic retinopathy study (DRS) guidelines for panretinal laser photocoagulation procedures
|
Ranibizumab+PRP
n=31 Participants
Interventional Core Phase: Ranibizumab 0.5 mg as described for the ranibizumab mono arm and PRP treatment as described for the PRP mono arm until stability regarding morphological parameters is confirmed
|
|---|---|---|---|
|
Change From Baseline in Central Subfield Thickness at EOCS
|
-6.0 micrometer
Standard Deviation 15.1
|
36.2 micrometer
Standard Deviation 55.9
|
17.6 micrometer
Standard Deviation 46.7
|
SECONDARY outcome
Timeframe: Baseline, EOCSPopulation: FAS; LOCF. Only patients with both values at baseline and any post-baseline value were included.
Foveal center point retinal thickness was assessed by a central reading center using Optical Coherence Tomography images. A positive change value may indicate disease progression. One eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
Ranibizumab Mono
n=32 Participants
Interventional Core Phase: One intravitreal injection of ranibizumab 0.5 mg to the study eye monthly until stability regarding morphological parameters is confirmed (ie, no further improvement of morphology or no worsening of morphology for 3 consecutive months)
|
PRP Mono
n=31 Participants
Interventional Core Phase: Panretinal laser photocoagulation (PRP) treatment administered to the study eye in accordance with the modified diabetic retinopathy study (DRS) guidelines for panretinal laser photocoagulation procedures
|
Ranibizumab+PRP
n=31 Participants
Interventional Core Phase: Ranibizumab 0.5 mg as described for the ranibizumab mono arm and PRP treatment as described for the PRP mono arm until stability regarding morphological parameters is confirmed
|
|---|---|---|---|
|
Change From Baseline in Foveal Center Point Retinal Thickness at EOCS
|
-4.7 micrometer
Standard Deviation 21.2
|
48.1 micrometer
Standard Deviation 83.7
|
25.5 micrometer
Standard Deviation 53.5
|
SECONDARY outcome
Timeframe: Baseline to EOCSPopulation: Safety Set. This outcome measure was pre-specified for the ranibizumab mono and ranibizumab+PRP arms only.
The total number of ranibizumab injections until EOCS was calculated. One eye (study eye) contributed to the analysis. No statistical analysis was conducted.
Outcome measures
| Measure |
Ranibizumab Mono
n=35 Participants
Interventional Core Phase: One intravitreal injection of ranibizumab 0.5 mg to the study eye monthly until stability regarding morphological parameters is confirmed (ie, no further improvement of morphology or no worsening of morphology for 3 consecutive months)
|
PRP Mono
n=35 Participants
Interventional Core Phase: Panretinal laser photocoagulation (PRP) treatment administered to the study eye in accordance with the modified diabetic retinopathy study (DRS) guidelines for panretinal laser photocoagulation procedures
|
Ranibizumab+PRP
n=36 Participants
Interventional Core Phase: Ranibizumab 0.5 mg as described for the ranibizumab mono arm and PRP treatment as described for the PRP mono arm until stability regarding morphological parameters is confirmed
|
|---|---|---|---|
|
Number of Ranibizumab Injections Until EOCS
|
5.2 injections
Standard Deviation 2.3
|
NA injections
Standard Deviation NA
This outcome measure was pre-specified for the ranibizumab mono and ranibizumab+PRP arms only.
|
5.0 injections
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: Baseline to EOCSPopulation: Safety Set. Only patients with at least 1 laser therapy until EOCS are included in the analysis. This outcome measure was pre-specified for the PRP and the ranibizumab+PRP arms only.
The total number of PRP laser spots from baseline until EOCS was calculated. One eye (study eye) contributed to the analysis. No statistical analysis was conducted.
Outcome measures
| Measure |
Ranibizumab Mono
n=35 Participants
Interventional Core Phase: One intravitreal injection of ranibizumab 0.5 mg to the study eye monthly until stability regarding morphological parameters is confirmed (ie, no further improvement of morphology or no worsening of morphology for 3 consecutive months)
|
PRP Mono
n=35 Participants
Interventional Core Phase: Panretinal laser photocoagulation (PRP) treatment administered to the study eye in accordance with the modified diabetic retinopathy study (DRS) guidelines for panretinal laser photocoagulation procedures
|
Ranibizumab+PRP
n=36 Participants
Interventional Core Phase: Ranibizumab 0.5 mg as described for the ranibizumab mono arm and PRP treatment as described for the PRP mono arm until stability regarding morphological parameters is confirmed
|
|---|---|---|---|
|
Number of PRP Laser Spots Until EOCS
|
NA PRP laser spots
Standard Deviation NA
This outcome measure was pre-specified for the PRP and the ranibizumab+PRP arms only.
|
1919.4 PRP laser spots
Standard Deviation 673.1
|
1670.0 PRP laser spots
Standard Deviation 568.4
|
Adverse Events
Ranibizumab Mono Until Month 12
Serious events: 8 serious events
Other events: 34 other events
Deaths: 1 deaths
PRP Mono Until Month 12
Serious events: 11 serious events
Other events: 29 other events
Deaths: 1 deaths
Ranibizumab+PRP Until Month 12
Serious events: 16 serious events
Other events: 34 other events
Deaths: 2 deaths
Ranibizumab Mono Month 12 to 24
Serious events: 5 serious events
Other events: 21 other events
Deaths: 0 deaths
PRP Mono Month 12 to 24
Serious events: 5 serious events
Other events: 12 other events
Deaths: 0 deaths
Ranibizumab+PRP Month 12 to 24
Serious events: 11 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ranibizumab Mono Until Month 12
n=35 participants at risk
All visits up to Month 12 (which could lie after EOCS for patients who discontinued the core phase of the study)
|
PRP Mono Until Month 12
n=35 participants at risk
All visits up to Month 12 (which could lie after EOCS for patients who discontinued the core phase of the study)
|
Ranibizumab+PRP Until Month 12
n=36 participants at risk
All visits up to Month 12 (which could lie after EOCS for patients who discontinued the core phase of the study)
|
Ranibizumab Mono Month 12 to 24
n=28 participants at risk
Non-interventional follow up phase
|
PRP Mono Month 12 to 24
n=20 participants at risk
Non-interventional follow up phase
|
Ranibizumab+PRP Month 12 to 24
n=25 participants at risk
Non-interventional follow up phase
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION (Non-ocular)
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Cardiac disorders
ATRIAL FIBRILLATION (Non-ocular)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Cardiac disorders
CONGESTIVE CARDIOMYOPATHY (Non-ocular)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
4.0%
1/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Cardiac disorders
CORONARY ARTERY DISEASE (Non-ocular)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
2.8%
1/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Cardiac disorders
HEART VALVE STENOSIS (Non-ocular)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
5.0%
1/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Ear and labyrinth disorders
SUDDEN HEARING LOSS (Non-ocular)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
ANTERIOR CHAMBER DISORDER (Right eye)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
3.6%
1/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
CATARACT (Left eye)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
2.8%
1/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
CATARACT (Right eye)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
3.6%
1/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
DIABETIC RETINAL OEDEMA (Left eye)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
2.8%
1/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
DIABETIC RETINAL OEDEMA (Right eye)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
2.8%
1/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
3.6%
1/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
DIABETIC RETINOPATHY (Left eye)
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
10.0%
2/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
8.0%
2/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
DIABETIC RETINOPATHY (Right eye)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
5.6%
2/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
5.0%
1/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
4.0%
1/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
GLAUCOMA (Right eye)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
3.6%
1/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
MACULAR FIBROSIS (Left eye)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
3.6%
1/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
MACULAR FIBROSIS (Right eye)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
3.6%
1/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
MACULAR OEDEMA (Left eye)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
2.8%
1/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
OPEN ANGLE GLAUCOMA (Right eye)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
RETINAL DETACHMENT (Left eye)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
2.8%
1/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
RETINAL HAEMORRHAGE (Both eyes)
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
3.6%
1/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
RETINAL HAEMORRHAGE (Right eye)
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
RETINAL NEOVASCULARISATION (Right eye)
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
4.0%
1/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
VISUAL ACUITY REDUCED (Left eye)
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
VITREOUS ADHESIONS (Right eye)
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
VITREOUS HAEMORRHAGE (Left eye)
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
2.8%
1/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
4.0%
1/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
VITREOUS HAEMORRHAGE (Right eye)
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
5.7%
2/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
8.0%
2/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN (Non-ocular)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
3.6%
1/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
CHRONIC GASTRITIS (Non-ocular)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
4.0%
1/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
DENTAL CYST (Non-ocular)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
4.0%
1/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
DIARRHOEA (Non-ocular)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
4.0%
1/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
UMBILICAL HERNIA (Non-ocular)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
4.0%
1/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
General disorders
CHEST PAIN (Non-ocular)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
4.0%
1/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION (Non-ocular)
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
General disorders
NON-CARDIAC CHEST PAIN (Non-ocular)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
General disorders
PERIPHERAL SWELLING (Non-ocular)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
4.0%
1/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Infections and infestations
GASTROENTERITIS (Non-ocular)
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
4.0%
1/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Infections and infestations
INFECTED SKIN ULCER (Non-ocular)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
2.8%
1/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Infections and infestations
LOCALISED INFECTION (Non-ocular)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
2.8%
1/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Infections and infestations
MENINGITIS (Non-ocular)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
4.0%
1/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Infections and infestations
OSTEOMYELITIS (Non-ocular)
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Infections and infestations
OSTEOMYELITIS CHRONIC (Non-ocular)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
4.0%
1/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Infections and infestations
POSTOPERATIVE WOUND INFECTION (Non-ocular)
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
FRACTURED COCCYX (Non-ocular)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
3.6%
1/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
HUMERUS FRACTURE (Non-ocular)
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
HYPHAEMA (Right eye)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
3.6%
1/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
KIDNEY CONTUSION (Non-ocular)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
2.8%
1/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
MENISCUS INJURY (Non-ocular)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
4.0%
1/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
RIB FRACTURE (Non-ocular)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
2.8%
1/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
SPINAL FRACTURE (Non-ocular)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
TENDON RUPTURE (Non-ocular)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
5.0%
1/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Investigations
BLOOD GLUCOSE FLUCTUATION (Non-ocular)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
2.8%
1/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
5.0%
1/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
DEHYDRATION (Non-ocular)
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS (Non-ocular)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
2.8%
1/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
3.6%
1/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
4.0%
1/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA (Non-ocular)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
2.8%
1/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
3.6%
1/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA (Non-ocular)
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
OBESITY (Non-ocular)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
2.8%
1/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
4.0%
1/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION (Non-ocular)
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
OSTEITIS (Non-ocular)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
2.8%
1/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CHRONIC LYMPHOCYTIC LEUKAEMIA (Non-ocular)
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
GASTRIC CANCER (Non-ocular)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
4.0%
1/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT (Non-ocular)
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
5.6%
2/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Nervous system disorders
DIZZINESS (Non-ocular)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
4.0%
1/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Pregnancy, puerperium and perinatal conditions
PREGNANCY (Non-ocular)
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Psychiatric disorders
PSYCHIATRIC DECOMPENSATION (Non-ocular)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
5.0%
1/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Renal and urinary disorders
CHRONIC KIDNEY DISEASE (Non-ocular)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
3.6%
1/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH (Non-ocular)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
4.0%
1/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA (Non-ocular)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
4.0%
1/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
COLD SWEAT (Non-ocular)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
4.0%
1/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
DIABETIC FOOT (Non-ocular)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
8.3%
3/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Vascular disorders
DIABETIC MICROANGIOPATHY (Non-ocular)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
2.8%
1/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Vascular disorders
HYPERTENSION (Non-ocular)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
4.0%
1/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Vascular disorders
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE (Non-ocular)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
2.8%
1/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Vascular disorders
PERIPHERAL ARTERY OCCLUSION (Non-ocular)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
4.0%
1/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Vascular disorders
PERIPHERAL VENOUS DISEASE (Non-ocular)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
2.8%
1/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
Other adverse events
| Measure |
Ranibizumab Mono Until Month 12
n=35 participants at risk
All visits up to Month 12 (which could lie after EOCS for patients who discontinued the core phase of the study)
|
PRP Mono Until Month 12
n=35 participants at risk
All visits up to Month 12 (which could lie after EOCS for patients who discontinued the core phase of the study)
|
Ranibizumab+PRP Until Month 12
n=36 participants at risk
All visits up to Month 12 (which could lie after EOCS for patients who discontinued the core phase of the study)
|
Ranibizumab Mono Month 12 to 24
n=28 participants at risk
Non-interventional follow up phase
|
PRP Mono Month 12 to 24
n=20 participants at risk
Non-interventional follow up phase
|
Ranibizumab+PRP Month 12 to 24
n=25 participants at risk
Non-interventional follow up phase
|
|---|---|---|---|---|---|---|
|
Infections and infestations
SINUSITIS (Non-ocular)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
5.7%
2/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
5.6%
2/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
8.0%
2/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
CONTUSION (Non-ocular)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
5.6%
2/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
3.6%
1/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Infections and infestations
RHINITIS (Non-ocular)
|
5.7%
2/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
2.8%
1/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Endocrine disorders
HYPOTHYROIDISM (Non-ocular)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
10.0%
2/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
ABNORMAL SENSATION IN EYE (Right eye)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
5.7%
2/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
BLEPHARITIS (Both eyes)
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
5.6%
2/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
CATARACT (Both eyes)
|
8.6%
3/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
2.8%
1/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
4.0%
1/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
CATARACT (Right eye)
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
7.1%
2/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
4.0%
1/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
CONJUNCTIVAL HAEMORRHAGE (Left eye)
|
8.6%
3/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
8.3%
3/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
3.6%
1/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
CONJUNCTIVAL HAEMORRHAGE (Right eye)
|
5.7%
2/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
5.6%
2/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
3.6%
1/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
5.0%
1/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
CONJUNCTIVITIS ALLERGIC (Both eyes)
|
8.6%
3/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
2.8%
1/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
CORNEAL EROSION (Left eye)
|
5.7%
2/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
16.7%
6/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
CORNEAL EROSION (Right eye)
|
8.6%
3/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
14.3%
5/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
2.8%
1/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
CYSTOID MACULAR OEDEMA (Right eye)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
5.7%
2/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
5.6%
2/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
DIABETIC RETINAL OEDEMA (Left eye)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
5.6%
2/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
4.0%
1/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
DIABETIC RETINAL OEDEMA (Right eye)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
16.7%
6/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
DIABETIC RETINOPATHY (Both eyes)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
5.6%
2/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
3.6%
1/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
DIABETIC RETINOPATHY (Left eye)
|
20.0%
7/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
19.4%
7/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
7.1%
2/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
16.0%
4/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
DIABETIC RETINOPATHY (Right eye)
|
11.4%
4/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
5.7%
2/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
8.3%
3/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
7.1%
2/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
DRY EYE (Both eyes)
|
8.6%
3/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
5.7%
2/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
5.6%
2/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
3.6%
1/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
4.0%
1/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
EYE IRRITATION (Left eye)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
11.1%
4/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
EYE IRRITATION (Right eye)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
8.3%
3/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
EYE PAIN (Left eye)
|
5.7%
2/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
8.6%
3/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
13.9%
5/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
EYE PAIN (Right eye)
|
8.6%
3/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
16.7%
6/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
3.6%
1/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
FOREIGN BODY SENSATION IN EYES (Left eye)
|
5.7%
2/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
FOREIGN BODY SENSATION IN EYES (Right eye)
|
5.7%
2/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
5.6%
2/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
GLARE (Right eye)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
5.7%
2/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
3.6%
1/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
IRIS NEOVASCULARISATION (Left eye)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
5.6%
2/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
IRIS NEOVASCULARISATION (Right eye)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
8.3%
3/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
4.0%
1/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
LACRIMATION INCREASED (Left eye)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
8.3%
3/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
5.0%
1/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
LACRIMATION INCREASED (Right eye)
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
5.6%
2/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
MACULAR FIBROSIS (Left eye)
|
8.6%
3/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
3.6%
1/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
MACULAR FIBROSIS (Right eye)
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
5.7%
2/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
8.3%
3/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
MACULAR OEDEMA (Both eyes)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
5.7%
2/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
5.6%
2/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
7.1%
2/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
4.0%
1/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
MACULAR OEDEMA (Left eye)
|
14.3%
5/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
11.4%
4/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
11.1%
4/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
7.1%
2/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
20.0%
4/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
12.0%
3/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
MACULAR OEDEMA (Right eye)
|
8.6%
3/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
22.9%
8/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
11.1%
4/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
17.9%
5/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
5.0%
1/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
16.0%
4/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
OCULAR DISCOMFORT (Left eye)
|
8.6%
3/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
OCULAR HYPERAEMIA (Left eye)
|
11.4%
4/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
11.1%
4/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
OCULAR HYPERAEMIA (Right eye)
|
8.6%
3/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
11.1%
4/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
PUNCTATE KERATITIS (Both eyes)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
8.6%
3/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
RETINAL CYST (Right eye)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
8.6%
3/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
4.0%
1/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
RETINAL EXUDATES (Left eye)
|
5.7%
2/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
5.7%
2/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
RETINAL HAEMORRHAGE (Left eye)
|
14.3%
5/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
8.3%
3/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
3.6%
1/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
4.0%
1/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
RETINAL HAEMORRHAGE (Right eye)
|
8.6%
3/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
8.3%
3/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
3.6%
1/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
8.0%
2/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
RETINAL ISCHAEMIA (Left eye)
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
5.6%
2/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
3.6%
1/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
4.0%
1/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
RETINAL NEOVASCULARISATION (Both eyes)
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
5.6%
2/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
20.0%
5/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
RETINAL NEOVASCULARISATION (Left eye)
|
14.3%
5/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
11.4%
4/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
25.0%
9/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
28.6%
8/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
16.0%
4/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
RETINAL NEOVASCULARISATION (Right eye)
|
34.3%
12/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
8.6%
3/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
27.8%
10/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
17.9%
5/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
10.0%
2/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
16.0%
4/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
VISION BLURRED (Right eye)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
5.7%
2/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
11.1%
4/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
VISUAL ACUITY REDUCED (Both eyes)
|
5.7%
2/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
5.6%
2/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
3.6%
1/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
4.0%
1/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
VISUAL ACUITY REDUCED (Left eye)
|
14.3%
5/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
8.6%
3/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
33.3%
12/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
7.1%
2/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
5.0%
1/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
4.0%
1/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
VISUAL ACUITY REDUCED (Right eye)
|
20.0%
7/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
25.7%
9/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
13.9%
5/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
10.7%
3/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
15.0%
3/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
4.0%
1/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
VISUAL IMPAIRMENT (Left eye)
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
5.6%
2/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
3.6%
1/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
4.0%
1/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
VITREOUS ADHESIONS (Right eye)
|
5.7%
2/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
5.7%
2/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
3.6%
1/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
VITREOUS DETACHMENT (Both eyes)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
5.7%
2/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
VITREOUS FLOATERS (Left eye)
|
8.6%
3/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
4.0%
1/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
VITREOUS FLOATERS (Right eye)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
5.6%
2/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
VITREOUS HAEMORRHAGE (Left eye)
|
17.1%
6/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
17.1%
6/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
13.9%
5/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
14.3%
4/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
10.0%
2/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
16.0%
4/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
VITREOUS HAEMORRHAGE (Right eye)
|
11.4%
4/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
20.0%
7/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
13.9%
5/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
10.7%
3/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
5.0%
1/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
28.0%
7/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
DIARRHOEA (Non-ocular)
|
5.7%
2/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
2.8%
1/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
NAUSEA (Non-ocular)
|
5.7%
2/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
3.6%
1/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
4.0%
1/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
TOOTHACHE (Non-ocular)
|
5.7%
2/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
2.8%
1/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
VOMITING (Non-ocular)
|
5.7%
2/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
4.0%
1/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Infections and infestations
BRONCHITIS (Non-ocular)
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
8.0%
2/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Infections and infestations
GASTROENTERITIS (Non-ocular)
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
11.1%
4/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Infections and infestations
HORDEOLUM (Left eye)
|
5.7%
2/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
5.7%
2/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
3.6%
1/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Infections and infestations
INFLUENZA (Non-ocular)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
5.7%
2/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
5.6%
2/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Infections and infestations
NASOPHARYNGITIS (Non-ocular)
|
20.0%
7/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
34.3%
12/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
25.0%
9/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
7.1%
2/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
10.0%
2/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
12.0%
3/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
FALL (Non-ocular)
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
8.6%
3/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
FOOT FRACTURE (Non-ocular)
|
5.7%
2/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
PROCEDURAL PAIN (Both eyes)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
8.3%
3/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
PROCEDURAL PAIN (Left eye)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
5.7%
2/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
11.1%
4/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
RIB FRACTURE (Non-ocular)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
8.0%
2/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
ROAD TRAFFIC ACCIDENT (Non-ocular)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
8.0%
2/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
SCRATCH (Non-ocular)
|
5.7%
2/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Investigations
BLOOD CHOLESTEROL INCREASED (Non-ocular)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
2.8%
1/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
10.7%
3/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
5.0%
1/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Investigations
BLOOD PRESSURE INCREASED (Non-ocular)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
7.1%
2/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Investigations
BLOOD TRIGLYCERIDES INCREASED (Non-ocular)
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
7.1%
2/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
10.0%
2/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
4.0%
1/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Investigations
GLYCOSYLATED HAEMOGLOBIN INCREASED (Non-ocular)
|
11.4%
4/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
16.7%
6/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
10.7%
3/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
10.0%
2/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
4.0%
1/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Investigations
INTRAOCULAR PRESSURE INCREASED (Left eye)
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
8.3%
3/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Investigations
INTRAOCULAR PRESSURE INCREASED (Right eye)
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
5.6%
2/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
HYPERCHOLESTEROLAEMIA (Non-ocular)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
5.6%
2/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
4.0%
1/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS (Non-ocular)
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
5.6%
2/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY (Non-ocular)
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
8.3%
3/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
3.6%
1/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
8.0%
2/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Nervous system disorders
HEADACHE (Non-ocular)
|
5.7%
2/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
11.4%
4/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
13.9%
5/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
4.0%
1/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH (Non-ocular)
|
11.4%
4/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
8.3%
3/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
DIABETIC FOOT (Non-ocular)
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
5.6%
2/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Vascular disorders
HYPERTENSION (Non-ocular)
|
5.7%
2/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
3.6%
1/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
5.0%
1/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
4.0%
1/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Eye disorders
RETINAL ISCHAEMIA (Right eye)
|
2.9%
1/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
5.6%
2/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
3.6%
1/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
4.0%
1/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
VITAMIN D DEFICIENCY (Non-ocular)
|
5.7%
2/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN (Non-ocular)
|
5.7%
2/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
5.7%
2/35 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/36 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
3.6%
1/28 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
0.00%
0/20 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
4.0%
1/25 • Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER