Trial Outcomes & Findings for A Study to Learn How Safe the Study Drug Intravitreal (Given by an Injection Into the Eye) Aflibercept is in Participants in India With Diabetic Macular Edema (NCT NCT05511038)
NCT ID: NCT05511038
Last Updated: 2025-09-04
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
100 participants
Primary outcome timeframe
An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
Results posted on
2025-09-04
Participant Flow
The trial was planned to be conducted at approximately 10-15 study sites across India. A total of 100 patients were enrolled into the study. The study duration was up to 13 months covering 11 visits.
121 patients were screened; 21 were screen failures and 100 patients were enrolled in the study: 85 patients in the naïve cohort and 15 patients in the pre-treated cohort
Participant milestones
| Measure |
Naïve
Participants who did not receive any previous/ prior treatment (i.e., participants that previously have not been treated with IVT anti-VEGF or steroids) within the last 3 months of the Day 1 of the study, without laser treatment, and without ocular surgery of the study eye are considered as naive
|
Pre-Treated
Participants who received any previous/ prior treatment for DME (i.e., participants that previously had been treated with IVT anti-VEGF or steroids or laser treatment/ ocular surgery for DME) before the last 3 months of the Day 1 of the study, in the study eye are considered as pre-treated
|
|---|---|---|
|
Overall
STARTED
|
105
|
16
|
|
Overall
COMPLETED
|
73
|
12
|
|
Overall
NOT COMPLETED
|
32
|
4
|
|
Screening
STARTED
|
105
|
16
|
|
Screening
COMPLETED
|
99
|
16
|
|
Screening
NOT COMPLETED
|
6
|
0
|
|
Treatment
STARTED
|
85
|
15
|
|
Treatment
COMPLETED
|
68
|
11
|
|
Treatment
NOT COMPLETED
|
17
|
4
|
Reasons for withdrawal
| Measure |
Naïve
Participants who did not receive any previous/ prior treatment (i.e., participants that previously have not been treated with IVT anti-VEGF or steroids) within the last 3 months of the Day 1 of the study, without laser treatment, and without ocular surgery of the study eye are considered as naive
|
Pre-Treated
Participants who received any previous/ prior treatment for DME (i.e., participants that previously had been treated with IVT anti-VEGF or steroids or laser treatment/ ocular surgery for DME) before the last 3 months of the Day 1 of the study, in the study eye are considered as pre-treated
|
|---|---|---|
|
Overall
Withdrawal by Subject
|
5
|
3
|
|
Overall
Screen Failure
|
20
|
1
|
|
Overall
Physician Decision
|
3
|
0
|
|
Overall
Lost to Follow-up
|
3
|
0
|
|
Overall
Death
|
1
|
0
|
|
Screening
Withdrawal by Subject
|
1
|
0
|
|
Screening
Lost to Follow Up (1 participant)
|
1
|
0
|
|
Screening
Screen Failure
|
3
|
0
|
|
Screening
Screen Failure that was identified after screening (1 participant)
|
1
|
0
|
|
Treatment
Withdrawal by Subject
|
5
|
3
|
|
Treatment
Physician Decision
|
4
|
0
|
|
Treatment
Lost to Follow-up
|
2
|
0
|
|
Treatment
Death
|
1
|
0
|
|
Treatment
Subject did nod visit the site despite multiple follow-up
|
3
|
1
|
|
Treatment
Refuse by subject
|
1
|
0
|
|
Treatment
Subject did not go to the site for visit
|
1
|
0
|
Baseline Characteristics
A Study to Learn How Safe the Study Drug Intravitreal (Given by an Injection Into the Eye) Aflibercept is in Participants in India With Diabetic Macular Edema
Baseline characteristics by cohort
| Measure |
Naïve
n=85 Participants
Participants who did not receive any previous/ prior treatment (i.e., participants that previously have not been treated with IVT anti-VEGF or steroids) within the last 3 months of the Day 1 of the study, without laser treatment, and without ocular surgery of the study eye are considered as naive
|
Pre-Treated
n=15 Participants
Participants who received any previous/ prior treatment for DME (i.e., participants that previously had been treated with IVT anti-VEGF or steroids or laser treatment/ ocular surgery for DME) before the last 3 months of the Day 1 of the study, in the study eye are considered as pre-treated
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.6 Years
STANDARD_DEVIATION 9.11 • n=5 Participants
|
59.4 Years
STANDARD_DEVIATION 9.01 • n=7 Participants
|
57.9 Years
STANDARD_DEVIATION 9.07 • n=5 Participants
|
|
Sex: Female, Male
Sex · Female
|
41 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Sex: Female, Male
Sex · Male
|
44 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Race · American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Race · Asian
|
85 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Race · Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Race · White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Race · More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Race · Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Weight (kg)
|
64.8 kilograms (kg)
STANDARD_DEVIATION 11.38 • n=5 Participants
|
62.4 kilograms (kg)
STANDARD_DEVIATION 11.12 • n=7 Participants
|
64.5 kilograms (kg)
STANDARD_DEVIATION 11.31 • n=5 Participants
|
|
Height (cm)
|
161.7 Centimeters (cm)
STANDARD_DEVIATION 9.18 • n=5 Participants
|
163.3 Centimeters (cm)
STANDARD_DEVIATION 8.83 • n=7 Participants
|
162.0 Centimeters (cm)
STANDARD_DEVIATION 9.11 • n=5 Participants
|
|
Body mass Index (kg/m2)
|
24.7 Kilograms per meter squared (kg/m2)
STANDARD_DEVIATION 3.63 • n=5 Participants
|
23.3 Kilograms per meter squared (kg/m2)
STANDARD_DEVIATION 2.99 • n=7 Participants
|
24.5 Kilograms per meter squared (kg/m2)
STANDARD_DEVIATION 3.57 • n=5 Participants
|
|
Number of patients with at least one medical history finding
Diabetic retinal oedema
|
83 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Number of patients with at least one medical history finding
Cataract
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Number of patients with at least one medical history finding
Type 2 diabetes mellitus
|
85 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Number of patients with at least one medical history finding
Hypertension
|
49 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.Outcome measures
| Measure |
Naïve
n=85 Participants
Participants who did not receive any previous/ prior treatment (i.e., participants that previously have not been treated with IVT anti-VEGF or steroids) within the last 3 months of the Day 1 of the study, without laser treatment, and without ocular surgery of the study eye are considered as naive
|
Pre-Treated
n=15 Participants
Participants who received any previous/ prior treatment for DME (i.e., participants that previously had been treated with IVT anti-VEGF or steroids or laser treatment/ ocular surgery for DME) before the last 3 months of the Day 1 of the study, in the study eye are considered as pre-treated
|
Total
n=100 Participants
Total number of participants
|
|---|---|---|---|
|
Frequency (Number) of Ocular and Non-ocular Treatment Emergent Adverse Events (TEAE).
Ocular
|
36.5 Percentage of participants
Interval 26.29 to 47.62
|
60 Percentage of participants
Interval 32.29 to 83.66
|
40 Percentage of participants
Interval 30.33 to 50.28
|
|
Frequency (Number) of Ocular and Non-ocular Treatment Emergent Adverse Events (TEAE).
Non-Ocular
|
21.2 Percentage of participants
Interval 13.06 to 31.39
|
33.3 Percentage of participants
Interval 11.82 to 61.62
|
23 Percentage of participants
Interval 15.17 to 32.49
|
SECONDARY outcome
Timeframe: From baseline to week 52Proportion of eyes that lose ≥ 5, 10 and 15 ETDRS letters from baseline to Week 52, Overall
Outcome measures
| Measure |
Naïve
n=85 Participants
Participants who did not receive any previous/ prior treatment (i.e., participants that previously have not been treated with IVT anti-VEGF or steroids) within the last 3 months of the Day 1 of the study, without laser treatment, and without ocular surgery of the study eye are considered as naive
|
Pre-Treated
n=14 Participants
Participants who received any previous/ prior treatment for DME (i.e., participants that previously had been treated with IVT anti-VEGF or steroids or laser treatment/ ocular surgery for DME) before the last 3 months of the Day 1 of the study, in the study eye are considered as pre-treated
|
Total
n=99 Participants
Total number of participants
|
|---|---|---|---|
|
The Change in BCVA From Baseline to Week 52, as Assessed Using the Early Treatment Diabetic Retinopathy Study (ETDRS) Chart or Equivalent.
≥ 5 ETDRS letters
|
2.4 Percentage of eyes
Interval 0.3 to 8.2
|
7.1 Percentage of eyes
Interval 0.2 to 33.9
|
3 Percentage of eyes
Interval 0.6 to 8.6
|
|
The Change in BCVA From Baseline to Week 52, as Assessed Using the Early Treatment Diabetic Retinopathy Study (ETDRS) Chart or Equivalent.
≥ 10 ETDRS letters
|
2.4 Percentage of eyes
Interval 0.3 to 8.2
|
0 Percentage of eyes
Interval 0.0 to 23.2
|
2 Percentage of eyes
Interval 0.2 to 7.1
|
|
The Change in BCVA From Baseline to Week 52, as Assessed Using the Early Treatment Diabetic Retinopathy Study (ETDRS) Chart or Equivalent.
≥ 15 ETDRS letters
|
2.4 Percentage of eyes
Interval 0.3 to 8.2
|
0 Percentage of eyes
Interval 0.0 to 23.2
|
2 Percentage of eyes
Interval 0.2 to 7.1
|
SECONDARY outcome
Timeframe: From baseline to week 52Outcome measures
| Measure |
Naïve
n=85 Participants
Participants who did not receive any previous/ prior treatment (i.e., participants that previously have not been treated with IVT anti-VEGF or steroids) within the last 3 months of the Day 1 of the study, without laser treatment, and without ocular surgery of the study eye are considered as naive
|
Pre-Treated
n=14 Participants
Participants who received any previous/ prior treatment for DME (i.e., participants that previously had been treated with IVT anti-VEGF or steroids or laser treatment/ ocular surgery for DME) before the last 3 months of the Day 1 of the study, in the study eye are considered as pre-treated
|
Total
n=99 Participants
Total number of participants
|
|---|---|---|---|
|
Change in Central Retinal Thickness (CRT) From Baseline to Week 52 as Measured by Optical Coherence Tomography (OCT), FA
|
-203.5 um
Standard Deviation 148.19
|
-160.3 um
Standard Deviation 127.42
|
-197.4 um
Standard Deviation 145.63
|
SECONDARY outcome
Timeframe: From baseline to Week 52Only 1 eye per patient was enrolled in the study. Therefore, number of participants equals to number of eyes.
Outcome measures
| Measure |
Naïve
n=85 Participants
Participants who did not receive any previous/ prior treatment (i.e., participants that previously have not been treated with IVT anti-VEGF or steroids) within the last 3 months of the Day 1 of the study, without laser treatment, and without ocular surgery of the study eye are considered as naive
|
Pre-Treated
n=14 Participants
Participants who received any previous/ prior treatment for DME (i.e., participants that previously had been treated with IVT anti-VEGF or steroids or laser treatment/ ocular surgery for DME) before the last 3 months of the Day 1 of the study, in the study eye are considered as pre-treated
|
Total
n=99 Participants
Total number of participants
|
|---|---|---|---|
|
Proportion of Eyes That Gained ≥ 5, 10 and 15 Early Treatment Diabetic Retinopathy Study (ETDRS) Letters From Baseline to Week 52
≥5 ETDRS letters
|
76 Participants
|
11 Participants
|
87 Participants
|
|
Proportion of Eyes That Gained ≥ 5, 10 and 15 Early Treatment Diabetic Retinopathy Study (ETDRS) Letters From Baseline to Week 52
≥10 ETDRS letters
|
63 Participants
|
11 Participants
|
74 Participants
|
|
Proportion of Eyes That Gained ≥ 5, 10 and 15 Early Treatment Diabetic Retinopathy Study (ETDRS) Letters From Baseline to Week 52
≥15 ETDRS letters
|
43 Participants
|
7 Participants
|
50 Participants
|
SECONDARY outcome
Timeframe: From baseline to Week 52Only 1 eye per patient was enrolled in the study. Therefore, number of participants equals to number of eyes. The Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) is a standardized tool used to measure the severity of diabetic retinopathy. The scale assesses the level of retinal damage and provides a score based on the presence of specific lesions and the extent of retinal involvement. Scale Range: * Minimum score: 10 (indicating no retinopathy) * Maximum score: 85 (indicating severe retinopathy) Interpretation of Scores: Higher scores indicate worse outcomes, reflecting more severe diabetic retinopathy
Outcome measures
| Measure |
Naïve
n=72 Participants
Participants who did not receive any previous/ prior treatment (i.e., participants that previously have not been treated with IVT anti-VEGF or steroids) within the last 3 months of the Day 1 of the study, without laser treatment, and without ocular surgery of the study eye are considered as naive
|
Pre-Treated
n=12 Participants
Participants who received any previous/ prior treatment for DME (i.e., participants that previously had been treated with IVT anti-VEGF or steroids or laser treatment/ ocular surgery for DME) before the last 3 months of the Day 1 of the study, in the study eye are considered as pre-treated
|
Total
n=84 Participants
Total number of participants
|
|---|---|---|---|
|
Proportion of Eyes With a ≥2 Step Improvement in the ETDRS Diabetic Retinopathy Severity Scale (DRSS) Score
|
12 Participants
|
3 Participants
|
15 Participants
|
Adverse Events
Pre-treated
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Drug Naive
Serious events: 4 serious events
Other events: 42 other events
Deaths: 1 deaths
Pre-treated (Ocular)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Drug Naive (Ocular)
Serious events: 0 serious events
Other events: 31 other events
Deaths: 1 deaths
Pre-treated (Non-ocular)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Drug Naive (Non-ocular)
Serious events: 4 serious events
Other events: 17 other events
Deaths: 1 deaths
Pre-treated (Study Eye)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Drug Naive (Study Eye)
Serious events: 0 serious events
Other events: 12 other events
Deaths: 1 deaths
Pre-treated (Fellow Eye)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Drug Naive (Fellow Eye)
Serious events: 0 serious events
Other events: 22 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Pre-treated
n=15 participants at risk
Participants who receive any previous/ prior treatment (i.e., participants that previously have not been treated with IVT anti-VEGF or steroids) within the last 3 months of the Day 1 of the study, without laser treatment, and without ocular surgery of the study
|
Drug Naive
n=85 participants at risk
Participants who did not receive any previous/ prior treatment (i.e., participants that previously have not been treated with IVT anti-VEGF or steroids) within the last 3 months of the Day 1 of the study, without laser treatment, and without ocular surgery of the study eye are considered as naive
|
Pre-treated (Ocular)
n=15 participants at risk
Participants who receive any previous/ prior treatment (i.e., participants that previously have not been treated with IVT anti-VEGF or steroids) within the last 3 months of the Day 1 of the study, without laser treatment, and without ocular surgery of the study and with ocular events
|
Drug Naive (Ocular)
n=85 participants at risk
Participants who did not receive any previous/ prior treatment (i.e., participants that previously have not been treated with IVT anti-VEGF or steroids) within the last 3 months of the Day 1 of the study, without laser treatment, and without ocular surgery of the study eye are considered as naive and with ocular events
|
Pre-treated (Non-ocular)
n=15 participants at risk
Participants who receive any previous/ prior treatment (i.e., participants that previously have not been treated with IVT anti-VEGF or steroids) within the last 3 months of the Day 1 of the study, without laser treatment, and without ocular surgery of the study and with non-ocular events
|
Drug Naive (Non-ocular)
n=85 participants at risk
Participants who did not receive any previous/ prior treatment (i.e., participants that previously have not been treated with IVT anti-VEGF or steroids) within the last 3 months of the Day 1 of the study, without laser treatment, and without ocular surgery of the study eye are considered as naive and with non-ocular events
|
Pre-treated (Study Eye)
n=15 participants at risk
Participants who receive any previous/ prior treatment (i.e., participants that previously have not been treated with IVT anti-VEGF or steroids) within the last 3 months of the Day 1 of the study, without laser treatment, and without ocular surgery of the study and with ocular events in study eye
|
Drug Naive (Study Eye)
n=85 participants at risk
Participants who did not receive any previous/ prior treatment (i.e., participants that previously have not been treated with IVT anti-VEGF or steroids) within the last 3 months of the Day 1 of the study, without laser treatment, and without ocular surgery of the study eye are considered as naive and with ocular events in study eye
|
Pre-treated (Fellow Eye)
n=15 participants at risk
Participants who receive any previous/ prior treatment (i.e., participants that previously have not been treated with IVT anti-VEGF or steroids) within the last 3 months of the Day 1 of the study, without laser treatment, and without ocular surgery of the study and with ocular events in fellow eye
|
Drug Naive (Fellow Eye)
n=85 participants at risk
Participants who did not receive any previous/ prior treatment (i.e., participants that previously have not been treated with IVT anti-VEGF or steroids) within the last 3 months of the Day 1 of the study, without laser treatment, and without ocular surgery of the study eye are considered as naive and with ocular events in fellow eye
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
2.4%
2/85 • Number of events 2 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
2.4%
2/85 • Number of events 4 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
1.2%
1/85 • Number of events 1 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
1.2%
1/85 • Number of events 2 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
1.2%
1/85 • Number of events 1 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
1.2%
1/85 • Number of events 2 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
1.2%
1/85 • Number of events 1 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
1.2%
1/85 • Number of events 2 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
1.2%
1/85 • Number of events 1 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
1.2%
1/85 • Number of events 2 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
|
Surgical and medical procedures
Breast conserving surgery
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
1.2%
1/85 • Number of events 1 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
1.2%
1/85 • Number of events 2 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
Other adverse events
| Measure |
Pre-treated
n=15 participants at risk
Participants who receive any previous/ prior treatment (i.e., participants that previously have not been treated with IVT anti-VEGF or steroids) within the last 3 months of the Day 1 of the study, without laser treatment, and without ocular surgery of the study
|
Drug Naive
n=85 participants at risk
Participants who did not receive any previous/ prior treatment (i.e., participants that previously have not been treated with IVT anti-VEGF or steroids) within the last 3 months of the Day 1 of the study, without laser treatment, and without ocular surgery of the study eye are considered as naive
|
Pre-treated (Ocular)
n=15 participants at risk
Participants who receive any previous/ prior treatment (i.e., participants that previously have not been treated with IVT anti-VEGF or steroids) within the last 3 months of the Day 1 of the study, without laser treatment, and without ocular surgery of the study and with ocular events
|
Drug Naive (Ocular)
n=85 participants at risk
Participants who did not receive any previous/ prior treatment (i.e., participants that previously have not been treated with IVT anti-VEGF or steroids) within the last 3 months of the Day 1 of the study, without laser treatment, and without ocular surgery of the study eye are considered as naive and with ocular events
|
Pre-treated (Non-ocular)
n=15 participants at risk
Participants who receive any previous/ prior treatment (i.e., participants that previously have not been treated with IVT anti-VEGF or steroids) within the last 3 months of the Day 1 of the study, without laser treatment, and without ocular surgery of the study and with non-ocular events
|
Drug Naive (Non-ocular)
n=85 participants at risk
Participants who did not receive any previous/ prior treatment (i.e., participants that previously have not been treated with IVT anti-VEGF or steroids) within the last 3 months of the Day 1 of the study, without laser treatment, and without ocular surgery of the study eye are considered as naive and with non-ocular events
|
Pre-treated (Study Eye)
n=15 participants at risk
Participants who receive any previous/ prior treatment (i.e., participants that previously have not been treated with IVT anti-VEGF or steroids) within the last 3 months of the Day 1 of the study, without laser treatment, and without ocular surgery of the study and with ocular events in study eye
|
Drug Naive (Study Eye)
n=85 participants at risk
Participants who did not receive any previous/ prior treatment (i.e., participants that previously have not been treated with IVT anti-VEGF or steroids) within the last 3 months of the Day 1 of the study, without laser treatment, and without ocular surgery of the study eye are considered as naive and with ocular events in study eye
|
Pre-treated (Fellow Eye)
n=15 participants at risk
Participants who receive any previous/ prior treatment (i.e., participants that previously have not been treated with IVT anti-VEGF or steroids) within the last 3 months of the Day 1 of the study, without laser treatment, and without ocular surgery of the study and with ocular events in fellow eye
|
Drug Naive (Fellow Eye)
n=85 participants at risk
Participants who did not receive any previous/ prior treatment (i.e., participants that previously have not been treated with IVT anti-VEGF or steroids) within the last 3 months of the Day 1 of the study, without laser treatment, and without ocular surgery of the study eye are considered as naive and with ocular events in fellow eye
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Eye disorders
Cataract
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
5.9%
5/85 • Number of events 5 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
5.9%
5/85 • Number of events 5 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
2.4%
2/85 • Number of events 2 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
3.5%
3/85 • Number of events 3 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
|
Eye disorders
Conjunctival haemorrhage
|
13.3%
2/15 • Number of events 2 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
1.2%
1/85 • Number of events 1 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
13.3%
2/15 • Number of events 2 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
1.2%
1/85 • Number of events 1 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
13.3%
2/15 • Number of events 2 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
1.2%
1/85 • Number of events 1 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
1.2%
1/85 • Number of events 1 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
1.2%
1/85 • Number of events 1 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
1.2%
1/85 • Number of events 1 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
|
Eye disorders
Diabetic retinal oedema
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
4.7%
4/85 • Number of events 5 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
4.7%
4/85 • Number of events 5 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
1.2%
1/85 • Number of events 1 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
3.5%
3/85 • Number of events 4 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
|
Eye disorders
Diabetic retinopathy
|
6.7%
1/15 • Number of events 1 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
2.4%
2/85 • Number of events 2 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
6.7%
1/15 • Number of events 1 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
2.4%
2/85 • Number of events 2 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
6.7%
1/15 • Number of events 1 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
2.4%
2/85 • Number of events 2 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
|
Eye disorders
Eye pain
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
1.2%
1/85 • Number of events 1 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
1.2%
1/85 • Number of events 1 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
1.2%
1/85 • Number of events 1 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
|
Eye disorders
Macular oedema
|
13.3%
2/15 • Number of events 2 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
10.6%
9/85 • Number of events 9 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
13.3%
2/15 • Number of events 2 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
10.6%
9/85 • Number of events 9 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
6.7%
1/15 • Number of events 1 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
2.4%
2/85 • Number of events 2 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
6.7%
1/15 • Number of events 1 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
8.2%
7/85 • Number of events 7 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
|
Eye disorders
Retinal detachment
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
1.2%
1/85 • Number of events 2 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
1.2%
1/85 • Number of events 2 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
1.2%
1/85 • Number of events 2 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
|
Eye disorders
Visual acuity reduced
|
6.7%
1/15 • Number of events 1 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
4.7%
4/85 • Number of events 4 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
6.7%
1/15 • Number of events 1 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
4.7%
4/85 • Number of events 4 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
6.7%
1/15 • Number of events 1 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
2.4%
2/85 • Number of events 2 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
2.4%
2/85 • Number of events 2 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
|
Eye disorders
Visual impairment
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
5.9%
5/85 • Number of events 5 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
5.9%
5/85 • Number of events 5 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
5.9%
5/85 • Number of events 5 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
|
Eye disorders
Vitreous haemorrhage
|
6.7%
1/15 • Number of events 1 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
2.4%
2/85 • Number of events 2 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
6.7%
1/15 • Number of events 1 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
2.4%
2/85 • Number of events 2 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
6.7%
1/15 • Number of events 1 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
2.4%
2/85 • Number of events 2 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
|
Eye disorders
Epiretinal membrane
|
6.7%
1/15 • Number of events 1 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
6.7%
1/15 • Number of events 1 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
6.7%
1/15 • Number of events 1 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
|
Eye disorders
Tractional retinal detachment
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
1.2%
1/85 • Number of events 1 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
1.2%
1/85 • Number of events 1 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
1.2%
1/85 • Number of events 1 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
|
Eye disorders
Macular thickening
|
13.3%
2/15 • Number of events 2 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
7.1%
6/85 • Number of events 6 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
13.3%
2/15 • Number of events 2 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
7.1%
6/85 • Number of events 6 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
6.7%
1/15 • Number of events 1 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
3.5%
3/85 • Number of events 3 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
6.7%
1/15 • Number of events 1 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
3.5%
3/85 • Number of events 3 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
1/15 • Number of events 1 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
6.7%
1/15 • Number of events 2 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
|
General disorders
Pyrexia
|
6.7%
1/15 • Number of events 1 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
2.4%
2/85 • Number of events 2 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
6.7%
1/15 • Number of events 2 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
2.4%
2/85 • Number of events 4 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
|
Infections and infestations
Conjunctivitis viral
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
1.2%
1/85 • Number of events 1 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
1.2%
1/85 • Number of events 1 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
1.2%
1/85 • Number of events 1 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
1.2%
1/85 • Number of events 1 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
1.2%
1/85 • Number of events 2 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
|
Infections and infestations
Pulpitis dental
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
1.2%
1/85 • Number of events 1 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
1.2%
1/85 • Number of events 2 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
|
Infections and infestations
Febrile infection
|
6.7%
1/15 • Number of events 1 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
1.2%
1/85 • Number of events 1 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
6.7%
1/15 • Number of events 2 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
1.2%
1/85 • Number of events 2 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
|
Investigations
Blood creatine increased
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
1.2%
1/85 • Number of events 1 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
1.2%
1/85 • Number of events 2 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
|
Investigations
Blood glucose increased
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
3.5%
3/85 • Number of events 3 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
3.5%
3/85 • Number of events 6 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
|
Investigations
Blood pressure increased
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
2.4%
2/85 • Number of events 2 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
2.4%
2/85 • Number of events 4 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
|
Investigations
Blood urea increased
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
1.2%
1/85 • Number of events 1 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
1.2%
1/85 • Number of events 2 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
|
Investigations
Glycosylated haemoglobin increased
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
1.2%
1/85 • Number of events 1 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
1.2%
1/85 • Number of events 2 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
1.2%
1/85 • Number of events 1 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
1.2%
1/85 • Number of events 2 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
1.2%
1/85 • Number of events 1 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
1.2%
1/85 • Number of events 2 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
1.2%
1/85 • Number of events 1 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
1.2%
1/85 • Number of events 2 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
1.2%
1/85 • Number of events 1 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
1.2%
1/85 • Number of events 2 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
|
Nervous system disorders
Headache
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
1.2%
1/85 • Number of events 1 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
1.2%
1/85 • Number of events 2 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
|
Renal and urinary disorders
Nephropathy
|
6.7%
1/15 • Number of events 1 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
6.7%
1/15 • Number of events 2 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
|
Renal and urinary disorders
Diabetic nephropathy
|
6.7%
1/15 • Number of events 1 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
6.7%
1/15 • Number of events 2 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
2.4%
2/85 • Number of events 2 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
2.4%
2/85 • Number of events 4 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
1.2%
1/85 • Number of events 1 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
1.2%
1/85 • Number of events 2 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
|
Vascular disorders
Hypertension
|
6.7%
1/15 • Number of events 1 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
1.2%
1/85 • Number of events 1 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
6.7%
1/15 • Number of events 2 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
1.2%
1/85 • Number of events 2 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/15 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
0.00%
0/85 • An AE arising or worsening after the start of study treatment administration until 30 days after the last administration of study treatment, up to 52 weeks.
* All-Cause Mortality: None of the events were clasified as Ocular Adverse Events * Serious Adverse Events: None of the events were clasified as Ocular Adverse Events. * Other Adverse Events: In this specific section, the risk populations and number affected, reflect eyes are meant to report the results of ocular events
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60