Trial Outcomes & Findings for A Comparison of Ranibizumab and Aflibercept for the Development of Geographic Atrophy in (Wet) AMD Patients (NCT NCT02130024)
NCT ID: NCT02130024
Last Updated: 2019-06-05
Results Overview
Multimodal images of the eye were obtained by trained study site personnel and forwarded to an independent Central Reading Center, where the area of GA was measured. Area was treated as zero if GA was reported as absent (Overall determination of GA presence). Mean change from baseline in GA area was reported in square root-transformed data (mm). One eye (study eye) contributed to the analysis.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
281 participants
Primary outcome timeframe
Baseline, Month 24
Results posted on
2019-06-05
Participant Flow
Patients were recruited and enrolled from 24 sites located in Australia.
This reporting group includes all patients randomized to treatment.
Participant milestones
| Measure |
Ranibizumab 0.5 mg
3 monthly loading doses (Baseline, Week 4, and Week 8), followed by an individualised treatment and evaluation regimen according to disease activity \[treat and extend\]
|
Aflibercept 2.0 mg
3 monthly loading doses (Baseline, Week 4, and Week 8), followed by an individualised treatment and evaluation regimen according to disease activity \[treat and extend\]
|
|---|---|---|
|
Overall Study
STARTED
|
142
|
139
|
|
Overall Study
Safety Set
|
141
|
139
|
|
Overall Study
Full Analysis Set (FAS)
|
141
|
137
|
|
Overall Study
COMPLETED
|
117
|
108
|
|
Overall Study
NOT COMPLETED
|
25
|
31
|
Reasons for withdrawal
| Measure |
Ranibizumab 0.5 mg
3 monthly loading doses (Baseline, Week 4, and Week 8), followed by an individualised treatment and evaluation regimen according to disease activity \[treat and extend\]
|
Aflibercept 2.0 mg
3 monthly loading doses (Baseline, Week 4, and Week 8), followed by an individualised treatment and evaluation regimen according to disease activity \[treat and extend\]
|
|---|---|---|
|
Overall Study
Adverse Event
|
10
|
11
|
|
Overall Study
Death
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Physician Decision
|
1
|
3
|
|
Overall Study
Protocol Deviation
|
4
|
0
|
|
Overall Study
Site Administration Problems
|
1
|
0
|
|
Overall Study
Subject Withdrew Consent
|
6
|
14
|
Baseline Characteristics
A Comparison of Ranibizumab and Aflibercept for the Development of Geographic Atrophy in (Wet) AMD Patients
Baseline characteristics by cohort
| Measure |
Ranibizumab 0.5 mg
n=142 Participants
3 monthly loading doses (Baseline, Week 4, and Week 8), followed by an individualised treatment and evaluation regimen according to disease activity \[treat and extend\]
|
Aflibercept 2.0 mg
n=139 Participants
3 monthly loading doses (Baseline, Week 4, and Week 8), followed by an individualised treatment and evaluation regimen according to disease activity \[treat and extend\]
|
Total
n=281 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
76.6 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
78.7 years
STANDARD_DEVIATION 7.45 • n=7 Participants
|
77.7 years
STANDARD_DEVIATION 8.06 • n=5 Participants
|
|
Sex: Female, Male
Female
|
72 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
148 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
70 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
132 participants
n=5 Participants
|
130 participants
n=7 Participants
|
262 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black African
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
8 participants
n=5 Participants
|
7 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 24Population: All randomized patients with at least one post-baseline efficacy value for the primary endpoint (FAS). Following the intent-to-treat principle, patients were analyzed according to the treatment regimen they were assigned to at randomization, with no imputation for missing data.
Multimodal images of the eye were obtained by trained study site personnel and forwarded to an independent Central Reading Center, where the area of GA was measured. Area was treated as zero if GA was reported as absent (Overall determination of GA presence). Mean change from baseline in GA area was reported in square root-transformed data (mm). One eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
Ranibizumab 0.5 mg
n=141 Participants
3 monthly loading doses (Baseline, Week 4, and Week 8), followed by an individualised treatment and evaluation regimen according to disease activity \[treat and extend\]
|
Aflibercept 2.0 mg
n=137 Participants
3 monthly loading doses (Baseline, Week 4, and Week 8), followed by an individualised treatment and evaluation regimen according to disease activity \[treat and extend\]
|
|---|---|---|
|
Mean Change in Square-root Area of Geographic Atrophy (GA) From Baseline to Month 24
Baseline
|
0.024 mm
Standard Deviation 0.0988
|
0.050 mm
Standard Deviation 0.2345
|
|
Mean Change in Square-root Area of Geographic Atrophy (GA) From Baseline to Month 24
Change from Baseline at Month 24
|
0.363 mm
Standard Deviation 0.7105
|
0.285 mm
Standard Deviation 0.5392
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: FAS. Following the intent-to-treat principle, patients were analyzed according to the treatment regimen they were assigned to at randomization, with no imputation for missing data.
Multimodal images of the eye were obtained by trained study site personnel and forwarded to an independent Central Reading Center, where the area of GA was measured. Area was treated as zero if GA was reported as absent (Overall determination of GA presence). Mean change from baseline in GA area was reported in square root-transformed data (mm). One eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
Ranibizumab 0.5 mg
n=141 Participants
3 monthly loading doses (Baseline, Week 4, and Week 8), followed by an individualised treatment and evaluation regimen according to disease activity \[treat and extend\]
|
Aflibercept 2.0 mg
n=137 Participants
3 monthly loading doses (Baseline, Week 4, and Week 8), followed by an individualised treatment and evaluation regimen according to disease activity \[treat and extend\]
|
|---|---|---|
|
Mean Change in Square-root Area of Geographic Atrophy From Baseline to Month 12
Baseline
|
0.024 mm
Standard Deviation 0.0988
|
0.050 mm
Standard Deviation 0.2345
|
|
Mean Change in Square-root Area of Geographic Atrophy From Baseline to Month 12
Change from Baseline at Month 12
|
0.155 mm
Standard Deviation 0.4272
|
0.145 mm
Standard Deviation 0.3179
|
SECONDARY outcome
Timeframe: Baseline, Month 12, Month 24Population: FAS. Following the intent-to-treat principle, patients were analyzed according to the treatment regimen they were assigned to at randomization, with no imputation for missing data.
Multimodal images of the eye were obtained by trained study site personnel and forwarded to an independent Central Reading Center. A patient was considered to have developed new GA if they did not have any GA at the start of the study period and were subsequently diagnosed with GA during the study period (diagnosis of GA change from "No" to "Yes)." The analysis of new GA development was restricted to only those subjects without GA reported at baseline. One eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
Ranibizumab 0.5 mg
n=141 Participants
3 monthly loading doses (Baseline, Week 4, and Week 8), followed by an individualised treatment and evaluation regimen according to disease activity \[treat and extend\]
|
Aflibercept 2.0 mg
n=137 Participants
3 monthly loading doses (Baseline, Week 4, and Week 8), followed by an individualised treatment and evaluation regimen according to disease activity \[treat and extend\]
|
|---|---|---|
|
Percentage of Patients With Newly Developed Geographic Atrophy During the Overall 24 Months of the Study
Baseline to Month 12
|
17.6 percentage of patients
|
20.3 percentage of patients
|
|
Percentage of Patients With Newly Developed Geographic Atrophy During the Overall 24 Months of the Study
Month 12 to Month 24
|
15.1 percentage of patients
|
7.2 percentage of patients
|
|
Percentage of Patients With Newly Developed Geographic Atrophy During the Overall 24 Months of the Study
Baseline to Month 24
|
28.8 percentage of patients
|
25.4 percentage of patients
|
SECONDARY outcome
Timeframe: Baseline, Month 12, Month 24Population: FAS. Following the intent-to-treat principle, patients were analyzed according to the treatment regimen they were assigned to at randomization, with no imputation for missing data.
The number of intravitreal injections was calculated. One eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
Ranibizumab 0.5 mg
n=141 Participants
3 monthly loading doses (Baseline, Week 4, and Week 8), followed by an individualised treatment and evaluation regimen according to disease activity \[treat and extend\]
|
Aflibercept 2.0 mg
n=137 Participants
3 monthly loading doses (Baseline, Week 4, and Week 8), followed by an individualised treatment and evaluation regimen according to disease activity \[treat and extend\]
|
|---|---|---|
|
Mean Number of Intravitreal Injections From Baseline to Month 12 and to Month 24
Baseline to Month 12
|
9.7 injections
Standard Deviation 2.78
|
9.7 injections
Standard Deviation 2.54
|
|
Mean Number of Intravitreal Injections From Baseline to Month 12 and to Month 24
Month 12 to Month 24
|
8.9 injections
Standard Deviation 3.24
|
8.3 injections
Standard Deviation 3.56
|
|
Mean Number of Intravitreal Injections From Baseline to Month 12 and to Month 24
Baseline to Month 24
|
17.7 injections
Standard Deviation 6.44
|
17.0 injections
Standard Deviation 6.3
|
SECONDARY outcome
Timeframe: Baseline, Month 12, Month 24Population: FAS. Following the intent-to-treat principle, patients were analyzed according to the treatment regimen they were assigned to at randomization, with no imputation for missing data.
Visual acuity was assessed with spectacles or other visual corrective devices in place using logMAR charts and recorded in number of letters correctly identified. BCVA change was defined as a change in letters correctly identified from the baseline assessment. A positive change value indicates an improvement in visual acuity, while a negative change value indicates a worsening. One eye (study eye) contributed to the analysis
Outcome measures
| Measure |
Ranibizumab 0.5 mg
n=141 Participants
3 monthly loading doses (Baseline, Week 4, and Week 8), followed by an individualised treatment and evaluation regimen according to disease activity \[treat and extend\]
|
Aflibercept 2.0 mg
n=137 Participants
3 monthly loading doses (Baseline, Week 4, and Week 8), followed by an individualised treatment and evaluation regimen according to disease activity \[treat and extend\]
|
|---|---|---|
|
Mean Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 12 and to Month 24
Baseline
|
65.3 letters
Standard Deviation 15.10
|
65.1 letters
Standard Deviation 12.53
|
|
Mean Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 12 and to Month 24
Change from Baseline at Month 12
|
6.9 letters
Standard Deviation 12.25
|
5.2 letters
Standard Deviation 12.83
|
|
Mean Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 12 and to Month 24
Change from Baseline at Month 24
|
6.5 letters
Standard Deviation 14.38
|
5.3 letters
Standard Deviation 13.33
|
SECONDARY outcome
Timeframe: Baseline, Month 12, Month 24Population: FAS. Following the intent-to-treat principle, patients were analyzed according to the treatment regimen they were assigned to at randomization, with no imputation for missing data.
CSFT (the average retinal thickness of the circular area within 1 millimeter diameter around the foveal center) was assessed using Optical Coherence Tomography (OCT) and measured in micrometers. A negative change value indicates an improvement, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis
Outcome measures
| Measure |
Ranibizumab 0.5 mg
n=141 Participants
3 monthly loading doses (Baseline, Week 4, and Week 8), followed by an individualised treatment and evaluation regimen according to disease activity \[treat and extend\]
|
Aflibercept 2.0 mg
n=137 Participants
3 monthly loading doses (Baseline, Week 4, and Week 8), followed by an individualised treatment and evaluation regimen according to disease activity \[treat and extend\]
|
|---|---|---|
|
Mean Change in Central Subfield Foveal Thickness (CSFT) From Baseline to Month 12 and to Month 24
Baseline
|
468.2 micrometers
Standard Deviation 150.82
|
483.5 micrometers
Standard Deviation 168.05
|
|
Mean Change in Central Subfield Foveal Thickness (CSFT) From Baseline to Month 12 and to Month 24
Change from Baseline at Month 12
|
-147.2 micrometers
Standard Deviation 128.38
|
-171.6 micrometers
Standard Deviation 150.12
|
|
Mean Change in Central Subfield Foveal Thickness (CSFT) From Baseline to Month 12 and to Month 24
Change from Baseline at Month 24
|
-151.3 micrometers
Standard Deviation 133.37
|
-181.7 micrometers
Standard Deviation 155.48
|
SECONDARY outcome
Timeframe: Month 2, Month 12, Month 24Population: FAS. Following the intent-to-treat principle, patients were analyzed according to the treatment regimen they were assigned to at randomization, with no imputation for missing data.
Intraretinal fluid and subretinal fluid was assessed using Optical Coherence Tomography (OCT) and recorded as Present/Absent. One eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
Ranibizumab 0.5 mg
n=141 Participants
3 monthly loading doses (Baseline, Week 4, and Week 8), followed by an individualised treatment and evaluation regimen according to disease activity \[treat and extend\]
|
Aflibercept 2.0 mg
n=137 Participants
3 monthly loading doses (Baseline, Week 4, and Week 8), followed by an individualised treatment and evaluation regimen according to disease activity \[treat and extend\]
|
|---|---|---|
|
Percentage of Patients Showing no Intraretinal Fluid (IRF)/Subretinal Fluid (SRF)
Month 2
|
56.9 percentage of patients
|
61.3 percentage of patients
|
|
Percentage of Patients Showing no Intraretinal Fluid (IRF)/Subretinal Fluid (SRF)
Month 12
|
55.9 percentage of patients
|
63.6 percentage of patients
|
|
Percentage of Patients Showing no Intraretinal Fluid (IRF)/Subretinal Fluid (SRF)
Month 24
|
57.3 percentage of patients
|
60.6 percentage of patients
|
SECONDARY outcome
Timeframe: Baseline, Month 12, Month 24Population: FAS. Following the intent-to-treat principle, patients were analyzed according to the treatment regimen they were assigned to at randomization, with no imputation for missing data.
Visual acuity was assessed with spectacles or other visual corrective devices in place using logMAR charts and recorded in number of letters correctly identified. A gain in letters correctly identified indicates an improvement in visual acuity, while a loss indicates a worsening. One eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
Ranibizumab 0.5 mg
n=141 Participants
3 monthly loading doses (Baseline, Week 4, and Week 8), followed by an individualised treatment and evaluation regimen according to disease activity \[treat and extend\]
|
Aflibercept 2.0 mg
n=137 Participants
3 monthly loading doses (Baseline, Week 4, and Week 8), followed by an individualised treatment and evaluation regimen according to disease activity \[treat and extend\]
|
|---|---|---|
|
Percentage of Patients Showing Greater Than and Equal to 15 Letters Gain for BCVA From Baseline to Month 12 and to Month 24
Change from Baseline at Month 12
|
22.0 percentage of patients
|
20.7 percentage of patients
|
|
Percentage of Patients Showing Greater Than and Equal to 15 Letters Gain for BCVA From Baseline to Month 12 and to Month 24
Change from Baseline at Month 24
|
24.8 percentage of patients
|
18.5 percentage of patients
|
SECONDARY outcome
Timeframe: Baseline, Month 12, Month 24Population: FAS. Following the intent-to-treat principle, patients were analyzed according to the treatment regimen they were assigned to at randomization, with no imputation for missing data.
Visual acuity was assessed with spectacles or other visual corrective devices in place using logMAR charts and recorded in number of letters correctly identified. A gain in letters correctly identified indicates an improvement in visual acuity, while a loss indicates a worsening. One eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
Ranibizumab 0.5 mg
n=141 Participants
3 monthly loading doses (Baseline, Week 4, and Week 8), followed by an individualised treatment and evaluation regimen according to disease activity \[treat and extend\]
|
Aflibercept 2.0 mg
n=137 Participants
3 monthly loading doses (Baseline, Week 4, and Week 8), followed by an individualised treatment and evaluation regimen according to disease activity \[treat and extend\]
|
|---|---|---|
|
Percentage of Patients Showing Less Than and Equal to 15 Letters Loss for BCVA From Baseline to Month 12 and to Month 24
Change from Baseline at Month 12
|
96.9 percentage of patients
|
95.0 percentage of patients
|
|
Percentage of Patients Showing Less Than and Equal to 15 Letters Loss for BCVA From Baseline to Month 12 and to Month 24
Change from Baseline at Month 24
|
94.0 percentage of patients
|
94.4 percentage of patients
|
SECONDARY outcome
Timeframe: Month 24Population: FAS. Following the intent-to-treat principle, patients were analyzed according to the treatment regimen they were assigned to at randomization, with no imputation for missing data. Descriptive statistics only.
The number of times the patient returned to a monthly injection interval (from an extended interval) at least once during the 24-month study was calculated. One eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
Ranibizumab 0.5 mg
n=134 Participants
3 monthly loading doses (Baseline, Week 4, and Week 8), followed by an individualised treatment and evaluation regimen according to disease activity \[treat and extend\]
|
Aflibercept 2.0 mg
n=134 Participants
3 monthly loading doses (Baseline, Week 4, and Week 8), followed by an individualised treatment and evaluation regimen according to disease activity \[treat and extend\]
|
|---|---|---|
|
Mean Number of Times a Patient Needed to Return to Monthly Intravitreal Injections Over 24 Months
|
2.3 occurrences
Standard Deviation 1.28
|
2.3 occurrences
Standard Deviation 1.15
|
SECONDARY outcome
Timeframe: Baseline, Week 5, Week 9Population: FAS. Following the intent-to-treat principle, patients were analyzed according to the treatment regimen they were assigned to at randomization, with no imputation for missing data.
Blood for VEGF plasma concentration analysis was collected at Baseline and again at 7 days after the injection at Week 4 and 7 days after the injection at Week 8.
Outcome measures
| Measure |
Ranibizumab 0.5 mg
n=141 Participants
3 monthly loading doses (Baseline, Week 4, and Week 8), followed by an individualised treatment and evaluation regimen according to disease activity \[treat and extend\]
|
Aflibercept 2.0 mg
n=137 Participants
3 monthly loading doses (Baseline, Week 4, and Week 8), followed by an individualised treatment and evaluation regimen according to disease activity \[treat and extend\]
|
|---|---|---|
|
Mean Change in Vascular Endothelial Growth Factor (VEGF) Plasma Concentration From Baseline to 7 Days After the Second and 7 Days After the Third Mandated Intravitreal Injection of Treatment
Baseline
|
44.29 picogram/milliliter (pg/mL)
Standard Deviation 43.369
|
41.88 picogram/milliliter (pg/mL)
Standard Deviation 35.236
|
|
Mean Change in Vascular Endothelial Growth Factor (VEGF) Plasma Concentration From Baseline to 7 Days After the Second and 7 Days After the Third Mandated Intravitreal Injection of Treatment
Change from Baseline at Week 5
|
-0.48 picogram/milliliter (pg/mL)
Standard Deviation 30.299
|
-26.37 picogram/milliliter (pg/mL)
Standard Deviation 36.220
|
|
Mean Change in Vascular Endothelial Growth Factor (VEGF) Plasma Concentration From Baseline to 7 Days After the Second and 7 Days After the Third Mandated Intravitreal Injection of Treatment
Change from Baseline at Week 9
|
0.48 picogram/milliliter (pg/mL)
Standard Deviation 35.125
|
-25.14 picogram/milliliter (pg/mL)
Standard Deviation 32.525
|
SECONDARY outcome
Timeframe: Baseline, Month 12, Month 24Population: Safety Set. All patients who received at least one application of study treatment and had at least one post-baseline safety assessment, as treated. Descriptive statistics only.
Retinal nerve fibre thickness was assessed using Optical Coherence Tomography (OCT) and measured in micrometers. A negative change in value (i.e. thinner nerve fibre) indicates nerve damage. One eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
Ranibizumab 0.5 mg
n=141 Participants
3 monthly loading doses (Baseline, Week 4, and Week 8), followed by an individualised treatment and evaluation regimen according to disease activity \[treat and extend\]
|
Aflibercept 2.0 mg
n=139 Participants
3 monthly loading doses (Baseline, Week 4, and Week 8), followed by an individualised treatment and evaluation regimen according to disease activity \[treat and extend\]
|
|---|---|---|
|
Percentage of Patients With Change in Retinal Nerve Fibre Thickness From Baseline to Month 12 and Month 24
Month 12: No Change from Baseline
|
96.7 percentage of patients
|
97.3 percentage of patients
|
|
Percentage of Patients With Change in Retinal Nerve Fibre Thickness From Baseline to Month 12 and Month 24
Month 12: Decrease from Baseline
|
2.5 percentage of patients
|
2.7 percentage of patients
|
|
Percentage of Patients With Change in Retinal Nerve Fibre Thickness From Baseline to Month 12 and Month 24
Month 12: Increase from Baseline
|
0.8 percentage of patients
|
0 percentage of patients
|
|
Percentage of Patients With Change in Retinal Nerve Fibre Thickness From Baseline to Month 12 and Month 24
Month 24: Decrease from Baseline
|
3.6 percentage of patients
|
1.0 percentage of patients
|
|
Percentage of Patients With Change in Retinal Nerve Fibre Thickness From Baseline to Month 12 and Month 24
Month 24: No Change from Baseline
|
96.4 percentage of patients
|
97.9 percentage of patients
|
|
Percentage of Patients With Change in Retinal Nerve Fibre Thickness From Baseline to Month 12 and Month 24
Month 24: Increase from Baseline
|
0 percentage of patients
|
1.0 percentage of patients
|
SECONDARY outcome
Timeframe: Baseline, Week 9Population: Safety Set. All patients who received at least one application of study treatment and had at least one post-baseline safety assessment, as treated. Descriptive statistics only.
Anterior cell grade was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0=0 cells; Grade 1=1 to 10 cells; Grade 2=11 to 20 cells; Grade 3=21 to 50 cells; Grade 4=\>50 cells. The presence of blood cells (red and white) in the anterior chamber of the eye (the fluid-filled space inside the eye between the iris and the cornea's innermost surface) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. One eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
Ranibizumab 0.5 mg
n=141 Participants
3 monthly loading doses (Baseline, Week 4, and Week 8), followed by an individualised treatment and evaluation regimen according to disease activity \[treat and extend\]
|
Aflibercept 2.0 mg
n=138 Participants
3 monthly loading doses (Baseline, Week 4, and Week 8), followed by an individualised treatment and evaluation regimen according to disease activity \[treat and extend\]
|
|---|---|---|
|
Percentage of Patients With Ocular Inflammation at Baseline and 7 Days Post-injection Following 3rd Mandated Intravitreal Injection - Anterior Chamber Cells
Baseline: Grade 0
|
99.3 percentage of patients
|
98.5 percentage of patients
|
|
Percentage of Patients With Ocular Inflammation at Baseline and 7 Days Post-injection Following 3rd Mandated Intravitreal Injection - Anterior Chamber Cells
Baseline: Grade 1+
|
0.7 percentage of patients
|
1.5 percentage of patients
|
|
Percentage of Patients With Ocular Inflammation at Baseline and 7 Days Post-injection Following 3rd Mandated Intravitreal Injection - Anterior Chamber Cells
Baseline: Grade 2+
|
0 percentage of patients
|
0 percentage of patients
|
|
Percentage of Patients With Ocular Inflammation at Baseline and 7 Days Post-injection Following 3rd Mandated Intravitreal Injection - Anterior Chamber Cells
Baseline: Grade 3+
|
0 percentage of patients
|
0 percentage of patients
|
|
Percentage of Patients With Ocular Inflammation at Baseline and 7 Days Post-injection Following 3rd Mandated Intravitreal Injection - Anterior Chamber Cells
Baseline: Grade 4+
|
0 percentage of patients
|
0 percentage of patients
|
|
Percentage of Patients With Ocular Inflammation at Baseline and 7 Days Post-injection Following 3rd Mandated Intravitreal Injection - Anterior Chamber Cells
Week 9: Grade 0
|
95.1 percentage of patients
|
92.7 percentage of patients
|
|
Percentage of Patients With Ocular Inflammation at Baseline and 7 Days Post-injection Following 3rd Mandated Intravitreal Injection - Anterior Chamber Cells
Week 9: Grade 1+
|
4.9 percentage of patients
|
7.3 percentage of patients
|
|
Percentage of Patients With Ocular Inflammation at Baseline and 7 Days Post-injection Following 3rd Mandated Intravitreal Injection - Anterior Chamber Cells
Week 9: Grade 2+
|
0 percentage of patients
|
0 percentage of patients
|
|
Percentage of Patients With Ocular Inflammation at Baseline and 7 Days Post-injection Following 3rd Mandated Intravitreal Injection - Anterior Chamber Cells
Week 9: Grade 3+
|
0 percentage of patients
|
0 percentage of patients
|
|
Percentage of Patients With Ocular Inflammation at Baseline and 7 Days Post-injection Following 3rd Mandated Intravitreal Injection - Anterior Chamber Cells
Week 9: Grade 4+
|
0 percentage of patients
|
0 percentage of patients
|
SECONDARY outcome
Timeframe: Baseline, Week 9Population: Safety Set. All patients who received at least one application of study treatment and had at least one post-baseline safety assessment, as treated. Descriptive statistics only.
Anterior chamber flare was assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = none; 1 = mild (trace to clearly noticeable, visible); 2 = moderate; 3 = marked; and 4 = severe. The presence of flare (increased protein levels) in the anterior chamber of the eye (the fluid-filled space inside the eye between the iris and the cornea's innermost surface) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. Proportion of patients is reported as a percentage. One eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
Ranibizumab 0.5 mg
n=141 Participants
3 monthly loading doses (Baseline, Week 4, and Week 8), followed by an individualised treatment and evaluation regimen according to disease activity \[treat and extend\]
|
Aflibercept 2.0 mg
n=138 Participants
3 monthly loading doses (Baseline, Week 4, and Week 8), followed by an individualised treatment and evaluation regimen according to disease activity \[treat and extend\]
|
|---|---|---|
|
Percentage of Patients With Ocular Inflammation at Baseline and 7 Days Post-injection Following 3rd Mandated Intravitreal Injection - Anterior Chamber Flare
Week 9: Grade 3+
|
0 percentage of patients
|
0 percentage of patients
|
|
Percentage of Patients With Ocular Inflammation at Baseline and 7 Days Post-injection Following 3rd Mandated Intravitreal Injection - Anterior Chamber Flare
Baseline: Grade 1+
|
2.2 percentage of patients
|
0.7 percentage of patients
|
|
Percentage of Patients With Ocular Inflammation at Baseline and 7 Days Post-injection Following 3rd Mandated Intravitreal Injection - Anterior Chamber Flare
Baseline: Grade 2+
|
0 percentage of patients
|
0 percentage of patients
|
|
Percentage of Patients With Ocular Inflammation at Baseline and 7 Days Post-injection Following 3rd Mandated Intravitreal Injection - Anterior Chamber Flare
Baseline: Grade 0
|
97.8 percentage of patients
|
99.3 percentage of patients
|
|
Percentage of Patients With Ocular Inflammation at Baseline and 7 Days Post-injection Following 3rd Mandated Intravitreal Injection - Anterior Chamber Flare
Baseline: Grade 3+
|
0 percentage of patients
|
0 percentage of patients
|
|
Percentage of Patients With Ocular Inflammation at Baseline and 7 Days Post-injection Following 3rd Mandated Intravitreal Injection - Anterior Chamber Flare
Baseline: Grade 4+
|
0 percentage of patients
|
0 percentage of patients
|
|
Percentage of Patients With Ocular Inflammation at Baseline and 7 Days Post-injection Following 3rd Mandated Intravitreal Injection - Anterior Chamber Flare
Week 9: Grade 0
|
94.3 percentage of patients
|
92.7 percentage of patients
|
|
Percentage of Patients With Ocular Inflammation at Baseline and 7 Days Post-injection Following 3rd Mandated Intravitreal Injection - Anterior Chamber Flare
Week 9: Grade 1+
|
5.7 percentage of patients
|
7.3 percentage of patients
|
|
Percentage of Patients With Ocular Inflammation at Baseline and 7 Days Post-injection Following 3rd Mandated Intravitreal Injection - Anterior Chamber Flare
Week 9: Grade 2+
|
0 percentage of patients
|
0 percentage of patients
|
|
Percentage of Patients With Ocular Inflammation at Baseline and 7 Days Post-injection Following 3rd Mandated Intravitreal Injection - Anterior Chamber Flare
Week 9: Grade 4+
|
0 percentage of patients
|
0 percentage of patients
|
Adverse Events
Ranibizumab 0.5 mg
Serious events: 50 serious events
Other events: 122 other events
Deaths: 3 deaths
Aflibercept 2.0 mg
Serious events: 58 serious events
Other events: 123 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Ranibizumab 0.5 mg
n=141 participants at risk
3 monthly loading doses (Baseline, Week 4, and Week 8), followed by an individualised treatment and evaluation regimen according to disease activity \[treat and extend\]
|
Aflibercept 2.0 mg
n=139 participants at risk
3 monthly loading doses (Baseline, Week 4, and Week 8), followed by an individualised treatment and evaluation regimen according to disease activity \[treat and extend\]
|
|---|---|---|
|
Cardiac disorders
Tachycardia (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Cardiac disorders
Ventricular tachycardia (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Ear and labyrinth disorders
Meniere's disease (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Blood and lymphatic system disorders
Anaemia (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Blood and lymphatic system disorders
Platelet dysfunction (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Cardiac disorders
Acute myocardial infarction (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Cardiac disorders
Aortic valve incompetence (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Cardiac disorders
Atrial fibrillation (Non-ocular)
|
5.0%
7/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Cardiac disorders
Atrioventricular block complete (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Cardiac disorders
Cardiac arrest (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Cardiac disorders
Cardiac failure (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Cardiac disorders
Cardiac failure chronic (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Cardiac disorders
Cardiac failure congestive (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Cardiac disorders
Coronary artery disease (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Cardiac disorders
Left ventricular failure (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
1.4%
2/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Cardiac disorders
Myocardial infarction (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Cardiac disorders
Palpitations (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Eye disorders
Retinal artery embolism (Right eye)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Eye disorders
Retinal artery occlusion (Right eye)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Eye disorders
Retinal detachment (Left eye)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
1.4%
2/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Gastrointestinal disorders
Constipation (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Gastrointestinal disorders
Diarrhoea (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Gastrointestinal disorders
Diverticulum (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Gastrointestinal disorders
Gastritis (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Gastrointestinal disorders
Intestinal obstruction (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Gastrointestinal disorders
Localised intraabdominal fluid collection (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Gastrointestinal disorders
Nausea (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Gastrointestinal disorders
Oesophageal food impaction (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Gastrointestinal disorders
Peritoneal adhesions (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Gastrointestinal disorders
Pharyngo-oesophageal diverticulum (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Gastrointestinal disorders
Rectal haemorrhage (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Gastrointestinal disorders
Small intestinal obstruction (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Gastrointestinal disorders
Volvulus (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Gastrointestinal disorders
Vomiting (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
General disorders
Chest pain (Non-ocular)
|
2.1%
3/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
1.4%
2/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
General disorders
Condition aggravated (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
1.4%
2/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
General disorders
Death (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
General disorders
Disease progression (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
General disorders
General physical health deterioration (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
General disorders
Hernia (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
General disorders
Pyrexia (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Hepatobiliary disorders
Bile duct stone (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
1.4%
2/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Hepatobiliary disorders
Cholecystitis (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Infections and infestations
Blastocystis infection (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Infections and infestations
Cellulitis (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
1.4%
2/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Infections and infestations
Clostridium difficile colitis (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Infections and infestations
Cystitis (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Infections and infestations
Endophthalmitis (Left eye)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Infections and infestations
Endophthalmitis (Right eye)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Infections and infestations
Escherichia infection (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Infections and infestations
Gallbladder empyema (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Infections and infestations
Gastroenteritis (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Infections and infestations
Gastroenteritis viral (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Infections and infestations
Herpes zoster (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease (Non-ocular)
|
1.4%
2/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Infections and infestations
Influenza (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Infections and infestations
Localised infection (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Infections and infestations
Lower respiratory tract infection (Non-ocular)
|
1.4%
2/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Infections and infestations
Onychomycosis (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Infections and infestations
Pneumonia (Non-ocular)
|
2.8%
4/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.9%
4/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Infections and infestations
Pneumonia bacterial (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Infections and infestations
Rhinovirus infection (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Infections and infestations
Sepsis (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Infections and infestations
Septic shock (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Infections and infestations
Subcutaneous abscess (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Infections and infestations
Urinary tract infection (Non-ocular)
|
1.4%
2/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.9%
4/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Infections and infestations
Urinary tract infection bacterial (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Injury, poisoning and procedural complications
Ankle fracture (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Injury, poisoning and procedural complications
Back injury (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Injury, poisoning and procedural complications
Cataract traumatic (Right eye)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Injury, poisoning and procedural complications
Contusion (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Injury, poisoning and procedural complications
Facial bones fracture (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Injury, poisoning and procedural complications
Fall (Non-ocular)
|
2.1%
3/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Injury, poisoning and procedural complications
Femoral neck fracture (Non-ocular)
|
2.1%
3/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
1.4%
2/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Injury, poisoning and procedural complications
Femur fracture (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
1.4%
2/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Injury, poisoning and procedural complications
Fibula fracture (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Injury, poisoning and procedural complications
Foot fracture (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Injury, poisoning and procedural complications
Forearm fracture (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Injury, poisoning and procedural complications
Hip fracture (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Injury, poisoning and procedural complications
Humerus fracture (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Injury, poisoning and procedural complications
Jaw fracture (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Injury, poisoning and procedural complications
Joint injury (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Injury, poisoning and procedural complications
Laceration (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Injury, poisoning and procedural complications
Limb injury (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Injury, poisoning and procedural complications
Radius fracture (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Injury, poisoning and procedural complications
Rib fracture (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Injury, poisoning and procedural complications
Spinal column injury (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Injury, poisoning and procedural complications
Subdural haematoma (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Injury, poisoning and procedural complications
Tibia fracture (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Metabolism and nutrition disorders
Hypercalcaemia (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Metabolism and nutrition disorders
Hypoglycaemia (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Metabolism and nutrition disorders
Hypokalaemia (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Metabolism and nutrition disorders
Hyponatraemia (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
1.4%
2/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Metabolism and nutrition disorders
Malnutrition (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Metabolism and nutrition disorders
Metabolic acidosis (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Musculoskeletal and connective tissue disorders
Arthritis (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Musculoskeletal and connective tissue disorders
Back pain (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc space narrowing (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased (Non-ocular)
|
1.4%
2/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis (Non-ocular)
|
1.4%
2/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal gland cancer (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Angioimmunoblastic T-cell lymphoma (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma (Non-ocular)
|
5.0%
7/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
1.4%
2/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign ovarian tumour (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign uterine neoplasm (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal carcinoma (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
1.4%
2/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
1.4%
2/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mesothelioma (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myeloproliferative disorder (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal cancer metastatic (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sinonasal papilloma (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer metastatic (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma (Non-ocular)
|
2.8%
4/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.9%
4/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil cancer (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Nervous system disorders
Amnesia (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Nervous system disorders
Aphasia (Non-ocular)
|
2.1%
3/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Nervous system disorders
Basal ganglia haemorrhage (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Nervous system disorders
Cerebral artery thrombosis (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Nervous system disorders
Cerebrovascular accident (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.2%
3/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Nervous system disorders
Dementia (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Nervous system disorders
Dizziness (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Nervous system disorders
Dysarthria (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Nervous system disorders
Ischaemic stroke (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Nervous system disorders
Lacunar infarction (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Nervous system disorders
Neuralgia (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Nervous system disorders
Presyncope (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Nervous system disorders
Subarachnoid haemorrhage (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Nervous system disorders
Syncope (Non-ocular)
|
2.1%
3/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
1.4%
2/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Nervous system disorders
Transient ischaemic attack (Non-ocular)
|
1.4%
2/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Psychiatric disorders
Delirium (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Psychiatric disorders
Depression (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Renal and urinary disorders
Haematuria (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Renal and urinary disorders
Nephrolithiasis (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Renal and urinary disorders
Obstructive uropathy (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Renal and urinary disorders
Renal failure acute (Non-ocular)
|
2.1%
3/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
1.4%
2/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Renal and urinary disorders
Urethral haemorrhage (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Renal and urinary disorders
Urinary bladder haemorrhage (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Renal and urinary disorders
Urinary retention (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
1.4%
2/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Reproductive system and breast disorders
Ovarian cyst (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Reproductive system and breast disorders
Prostatomegaly (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Reproductive system and breast disorders
Uterovaginal prolapse (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Reproductive system and breast disorders
Vaginal ulceration (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
1.4%
2/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
1.4%
2/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure (Non-ocular)
|
1.4%
2/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Surgical and medical procedures
Open reduction of fracture (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Vascular disorders
Aortic dilatation (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Vascular disorders
Aortic embolus (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Vascular disorders
Aortic stenosis (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Vascular disorders
Hypertension (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Vascular disorders
Hypotension (Non-ocular)
|
1.4%
2/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
Other adverse events
| Measure |
Ranibizumab 0.5 mg
n=141 participants at risk
3 monthly loading doses (Baseline, Week 4, and Week 8), followed by an individualised treatment and evaluation regimen according to disease activity \[treat and extend\]
|
Aflibercept 2.0 mg
n=139 participants at risk
3 monthly loading doses (Baseline, Week 4, and Week 8), followed by an individualised treatment and evaluation regimen according to disease activity \[treat and extend\]
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia (Non-ocular)
|
2.8%
4/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.9%
4/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Cardiac disorders
Angina pectoris (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.2%
3/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Cardiac disorders
Atrial fibrillation (Non-ocular)
|
2.1%
3/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.9%
4/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Cardiac disorders
Bundle branch block left (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.2%
3/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Cardiac disorders
Tachycardia (Non-ocular)
|
1.4%
2/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.2%
3/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Ear and labyrinth disorders
Vertigo (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
3.6%
5/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Eye disorders
Age-related macular degeneration (Left eye)
|
4.3%
6/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
5.8%
8/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Eye disorders
Age-related macular degeneration (Right eye)
|
7.1%
10/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
10.1%
14/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Eye disorders
Blepharitis (Both eyes)
|
2.1%
3/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
1.4%
2/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Eye disorders
Cataract (Both eyes)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.2%
3/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Eye disorders
Cataract (Left eye)
|
2.1%
3/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
10.1%
14/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Eye disorders
Cataract (Right eye)
|
4.3%
6/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
5.8%
8/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Eye disorders
Chalazion (Left eye)
|
1.4%
2/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.9%
4/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Eye disorders
Chalazion (Right eye)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.2%
3/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Eye disorders
Choroidal neovascularisation (Left eye)
|
1.4%
2/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.2%
3/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Eye disorders
Choroidal neovascularisation (Right eye)
|
4.3%
6/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
3.6%
5/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Eye disorders
Conjunctival haemorrhage (Left eye)
|
4.3%
6/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.2%
3/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Eye disorders
Dry eye (Both eyes)
|
9.2%
13/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
6.5%
9/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Eye disorders
Dry eye (Left eye)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.2%
3/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Eye disorders
Eye discharge (Both eyes)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.2%
3/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Eye disorders
Eye discharge (Left eye)
|
2.1%
3/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Eye disorders
Eye discharge (Right eye)
|
1.4%
2/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.2%
3/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Eye disorders
Eye irritation (Both eyes)
|
1.4%
2/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.2%
3/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Eye disorders
Eye irritation (Left eye)
|
3.5%
5/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.2%
3/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Eye disorders
Eye irritation (Right eye)
|
1.4%
2/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.9%
4/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Eye disorders
Eye pain (Both eyes)
|
4.3%
6/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Eye disorders
Eye pain (Left eye)
|
7.1%
10/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
10.8%
15/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Eye disorders
Eye pain (Right eye)
|
9.9%
14/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
9.4%
13/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Eye disorders
Eye pruritus (Both eyes)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.9%
4/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Eye disorders
Lacrimation increased (Both eyes)
|
2.8%
4/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
3.6%
5/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Eye disorders
Lacrimation increased (Left eye)
|
3.5%
5/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.2%
3/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Eye disorders
Lacrimation increased (Right eye)
|
2.1%
3/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.2%
3/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Eye disorders
Macular degeneration (Right eye)
|
2.1%
3/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.2%
3/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Eye disorders
Metamorphopsia (Left eye)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.2%
3/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Eye disorders
Metamorphopsia (Right eye)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.2%
3/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Eye disorders
Ocular hyperaemia (Left eye)
|
2.1%
3/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
5.0%
7/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Eye disorders
Ocular hyperaemia (Right eye)
|
2.8%
4/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.9%
4/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Eye disorders
Posterior capsule opacification (Right eye)
|
1.4%
2/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.9%
4/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Eye disorders
Retinal haemorrhage (Left eye)
|
2.1%
3/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
3.6%
5/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Eye disorders
Retinal haemorrhage (Right eye)
|
3.5%
5/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.2%
3/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Eye disorders
Retinal pigment epithelial tear (Left eye)
|
3.5%
5/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.2%
3/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Eye disorders
Vision blurred (Both eyes)
|
2.8%
4/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Eye disorders
Vision blurred (Left eye)
|
1.4%
2/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
3.6%
5/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Eye disorders
Vision blurred (Right eye)
|
2.1%
3/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
4.3%
6/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Eye disorders
Visual acuity reduced (Right eye)
|
4.3%
6/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
1.4%
2/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Eye disorders
Vitreous detachment (Both eyes)
|
2.8%
4/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
1.4%
2/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Eye disorders
Vitreous detachment (Left eye)
|
2.1%
3/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
8.6%
12/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Eye disorders
Vitreous detachment (Right eye)
|
1.4%
2/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
7.9%
11/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Eye disorders
Vitreous floaters (Both eyes)
|
2.8%
4/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
1.4%
2/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Eye disorders
Vitreous floaters (Left eye)
|
5.0%
7/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
5.0%
7/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Eye disorders
Vitreous floaters (Right eye)
|
5.0%
7/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
6.5%
9/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Gastrointestinal disorders
Abdominal pain (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
3.6%
5/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Gastrointestinal disorders
Constipation (Non-ocular)
|
4.3%
6/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
9.4%
13/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Gastrointestinal disorders
Diarrhoea (Non-ocular)
|
5.0%
7/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
3.6%
5/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease (Non-ocular)
|
2.1%
3/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
7.2%
10/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Gastrointestinal disorders
Nausea (Non-ocular)
|
8.5%
12/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
4.3%
6/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Gastrointestinal disorders
Vomiting (Non-ocular)
|
2.8%
4/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
3.6%
5/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
General disorders
Asthenia (Non-ocular)
|
2.1%
3/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
General disorders
Chest pain (Non-ocular)
|
2.8%
4/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.9%
4/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
General disorders
Influenza like illness (Non-ocular)
|
5.7%
8/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.2%
3/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
General disorders
Malaise (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.9%
4/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
General disorders
Oedema peripheral (Non-ocular)
|
1.4%
2/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.2%
3/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
General disorders
Pain (Right eye)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.2%
3/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
General disorders
Pyrexia (Non-ocular)
|
2.8%
4/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
1.4%
2/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Immune system disorders
Drug hypersensitivity (Both eyes)
|
2.1%
3/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Immune system disorders
Drug hypersensitivity (Non-ocular)
|
2.8%
4/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.2%
3/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Immune system disorders
Seasonal allergy (Non-ocular)
|
4.3%
6/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Infections and infestations
Bronchitis (Non-ocular)
|
2.8%
4/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Infections and infestations
Cellulitis (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.2%
3/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Infections and infestations
Diverticulitis (Non-ocular)
|
2.1%
3/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Infections and infestations
Gastroenteritis (Non-ocular)
|
1.4%
2/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.2%
3/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Infections and infestations
Herpes zoster (Non-ocular)
|
2.8%
4/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.9%
4/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Infections and infestations
Influenza (Non-ocular)
|
7.8%
11/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
4.3%
6/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Infections and infestations
Lower respiratory tract infection (Non-ocular)
|
7.8%
11/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
4.3%
6/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Infections and infestations
Nasopharyngitis (Non-ocular)
|
10.6%
15/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
5.8%
8/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Infections and infestations
Pneumonia (Non-ocular)
|
1.4%
2/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.9%
4/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Infections and infestations
Sinusitis (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.2%
3/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Infections and infestations
Upper respiratory tract infection (Non-ocular)
|
5.7%
8/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
7.9%
11/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Infections and infestations
Urinary tract infection (Non-ocular)
|
7.8%
11/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
10.8%
15/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Injury, poisoning and procedural complications
Contusion (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.2%
3/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Injury, poisoning and procedural complications
Corneal abrasion (Right eye)
|
2.8%
4/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
1.4%
2/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Injury, poisoning and procedural complications
Fall (Non-ocular)
|
7.8%
11/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
10.8%
15/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Injury, poisoning and procedural complications
Head injury (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.2%
3/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Investigations
Abdominal X-ray (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.9%
4/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Investigations
Angiogram (Non-ocular)
|
2.8%
4/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.2%
3/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Investigations
Arteriogram coronary (Non-ocular)
|
2.1%
3/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.9%
4/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Investigations
Biopsy (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.9%
4/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Investigations
Blood alkaline phosphatase increased (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.2%
3/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Investigations
Blood chloride decreased (Non-ocular)
|
2.1%
3/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.2%
3/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Investigations
Blood cholesterol increased (Non-ocular)
|
2.1%
3/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Investigations
Blood creatinine increased (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.9%
4/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Investigations
Blood sodium decreased (Non-ocular)
|
2.1%
3/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
1.4%
2/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Investigations
Blood urea increased (Non-ocular)
|
1.4%
2/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.9%
4/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Investigations
C-reactive protein increased (Non-ocular)
|
2.1%
3/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
4.3%
6/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Investigations
Chest X-ray (Non-ocular)
|
9.9%
14/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
14.4%
20/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Investigations
Colonoscopy (Non-ocular)
|
4.3%
6/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
4.3%
6/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Investigations
Computerised tomogram (Non-ocular)
|
4.3%
6/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
12.9%
18/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Investigations
Computerised tomogram abdomen (Non-ocular)
|
2.1%
3/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
1.4%
2/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Investigations
Computerised tomogram head (Non-ocular)
|
7.8%
11/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
7.9%
11/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Investigations
Cystoscopy (Non-ocular)
|
1.4%
2/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.2%
3/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Investigations
Echocardiogram (Non-ocular)
|
6.4%
9/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
9.4%
13/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Investigations
Electrocardiogram (Non-ocular)
|
5.0%
7/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
3.6%
5/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Investigations
Electrocardiogram ambulatory (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.2%
3/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Investigations
Full blood count (Non-ocular)
|
2.1%
3/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Investigations
Gamma-glutamyltransferase increased (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.9%
4/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Investigations
Glomerular filtration rate decreased (Non-ocular)
|
1.4%
2/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.2%
3/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Investigations
Haematocrit decreased (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.9%
4/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Investigations
Haemoglobin decreased (Non-ocular)
|
1.4%
2/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.9%
4/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Investigations
International normalised ratio increased (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.2%
3/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Investigations
Intraocular pressure increased (Left eye)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.2%
3/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Investigations
Lymphocyte count decreased (Non-ocular)
|
1.4%
2/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.9%
4/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Investigations
Neutrophil count increased (Non-ocular)
|
1.4%
2/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
3.6%
5/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Investigations
Nuclear magnetic resonance imaging (Non-ocular)
|
1.4%
2/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.9%
4/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Investigations
Nuclear magnetic resonance imaging brain (Non-ocular)
|
3.5%
5/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.2%
3/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Investigations
Red blood cell count decreased (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.2%
3/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Investigations
Ultrasound Doppler (Non-ocular)
|
3.5%
5/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.9%
4/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Investigations
Ultrasound abdomen (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.2%
3/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Investigations
Ultrasound kidney (Non-ocular)
|
1.4%
2/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.2%
3/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Investigations
Weight decreased (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.2%
3/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Investigations
White blood cell count increased (Non-ocular)
|
1.4%
2/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
3.6%
5/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Investigations
X-ray (Non-ocular)
|
3.5%
5/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Investigations
X-ray limb (Non-ocular)
|
2.1%
3/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Investigations
X-ray of pelvis and hip (Non-ocular)
|
1.4%
2/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
3.6%
5/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia (Non-ocular)
|
3.5%
5/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Metabolism and nutrition disorders
Hypokalaemia (Non-ocular)
|
2.1%
3/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.9%
4/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Metabolism and nutrition disorders
Vitamin D deficiency (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.2%
3/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia (Non-ocular)
|
4.3%
6/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
5.0%
7/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Musculoskeletal and connective tissue disorders
Arthritis (Non-ocular)
|
2.8%
4/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
1.4%
2/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Musculoskeletal and connective tissue disorders
Back pain (Non-ocular)
|
6.4%
9/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
5.8%
8/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness (Non-ocular)
|
2.1%
3/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain (Non-ocular)
|
3.5%
5/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis (Non-ocular)
|
2.8%
4/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
1.4%
2/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.9%
4/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity (Non-ocular)
|
2.1%
3/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
1.4%
2/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Nervous system disorders
Dizziness (Non-ocular)
|
3.5%
5/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
5.0%
7/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Nervous system disorders
Headache (Non-ocular)
|
4.3%
6/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
8.6%
12/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Nervous system disorders
Lethargy (Non-ocular)
|
2.1%
3/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.2%
3/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Nervous system disorders
Migraine (Non-ocular)
|
2.1%
3/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Nervous system disorders
Neuralgia (Non-ocular)
|
2.1%
3/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Nervous system disorders
Sciatica (Non-ocular)
|
2.1%
3/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
1.4%
2/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Psychiatric disorders
Anxiety (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.9%
4/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Psychiatric disorders
Delirium (Non-ocular)
|
2.1%
3/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
1.4%
2/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Psychiatric disorders
Insomnia (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
5.0%
7/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Renal and urinary disorders
Haematuria (Non-ocular)
|
1.4%
2/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
4.3%
6/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Renal and urinary disorders
Renal cyst (Non-ocular)
|
1.4%
2/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.2%
3/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Renal and urinary disorders
Renal impairment (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.2%
3/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Renal and urinary disorders
Urinary incontinence (Non-ocular)
|
2.1%
3/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
1.4%
2/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma (Non-ocular)
|
2.1%
3/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Respiratory, thoracic and mediastinal disorders
Cough (Non-ocular)
|
7.8%
11/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
5.0%
7/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea (Non-ocular)
|
5.7%
8/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
3.6%
5/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain (Non-ocular)
|
1.4%
2/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.2%
3/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough (Non-ocular)
|
2.8%
4/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.72%
1/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Skin and subcutaneous tissue disorders
Rash (Non-ocular)
|
2.8%
4/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
4.3%
6/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Skin and subcutaneous tissue disorders
Skin lesion (Non-ocular)
|
2.1%
3/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Surgical and medical procedures
Cancer surgery (Non-ocular)
|
4.3%
6/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
3.6%
5/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Surgical and medical procedures
Cardiac pacemaker insertion (Non-ocular)
|
0.71%
1/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.2%
3/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Surgical and medical procedures
Cataract operation (Left eye)
|
2.8%
4/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
7.9%
11/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Surgical and medical procedures
Cataract operation (Right eye)
|
7.1%
10/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
5.0%
7/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Surgical and medical procedures
Hip arthroplasty (Non-ocular)
|
3.5%
5/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
4.3%
6/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Surgical and medical procedures
Inguinal hernia repair (Non-ocular)
|
0.00%
0/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.2%
3/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Surgical and medical procedures
Intraocular lens implant (Right eye)
|
1.4%
2/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.9%
4/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Surgical and medical procedures
Radiotherapy (Non-ocular)
|
2.1%
3/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
1.4%
2/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Surgical and medical procedures
Skin neoplasm excision (Non-ocular)
|
6.4%
9/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
4.3%
6/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Surgical and medical procedures
Transfusion (Non-ocular)
|
2.1%
3/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
0.00%
0/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Vascular disorders
Hypertension (Non-ocular)
|
5.7%
8/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
8.6%
12/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
|
Vascular disorders
Hypotension (Non-ocular)
|
3.5%
5/141 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
2.9%
4/139 • Adverse events were collected for the duration of the individual's participation in the study (approximately 24 months).
This analysis population includes all patients who received at least one application of study treatment and had at least one post-baseline safety assessment (Safety Analysis Set).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER