Trial Outcomes & Findings for Study of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in Patients With Diabetic Macular Edema (NCT NCT01363440)
NCT ID: NCT01363440
Last Updated: 2016-05-30
Results Overview
Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of 73 to 24 (= Acuity of 20/40 to 20/320) in the study eye were included; a higher score represents better functioning.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
466 participants
Primary outcome timeframe
Baseline and Week 52
Results posted on
2016-05-30
Participant Flow
Participants with diabetic macular edema (DME) secondary to diabetes mellitus involving the center of the macula in the study eye could participate in the study.
Of 687 participants who were screened for inclusion in the study, 466 were enrolled (started) and 461 received treatment.
Participant milestones
| Measure |
Macular Laser Photocoagulation Treatment (Control)
Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
|
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4
Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
|
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8
Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
156
|
156
|
154
|
|
Overall Study
Participants Received Treatment
|
154
|
155
|
152
|
|
Overall Study
Completed Week 52
|
145
|
146
|
144
|
|
Overall Study
Completed Week 100
|
133
|
125
|
127
|
|
Overall Study
COMPLETED
|
133
|
125
|
127
|
|
Overall Study
NOT COMPLETED
|
23
|
31
|
27
|
Reasons for withdrawal
| Measure |
Macular Laser Photocoagulation Treatment (Control)
Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
|
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4
Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
|
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8
Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
5
|
4
|
4
|
|
Overall Study
Death
|
3
|
7
|
5
|
|
Overall Study
Withdrawal by Subject
|
9
|
11
|
11
|
|
Overall Study
Lost to Follow-up
|
2
|
4
|
5
|
|
Overall Study
Other
|
4
|
5
|
2
|
Baseline Characteristics
Study of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in Patients With Diabetic Macular Edema
Baseline characteristics by cohort
| Measure |
Control
n=154 Participants
Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
|
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4
n=155 Participants
Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
|
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8
n=152 Participants
Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
|
Total
n=461 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
61.7 years
STANDARD_DEVIATION 8.65 • n=5 Participants
|
62 years
STANDARD_DEVIATION 11.16 • n=7 Participants
|
63.1 years
STANDARD_DEVIATION 9.36 • n=5 Participants
|
62.2 years
STANDARD_DEVIATION 9.7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
210 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
85 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
251 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 52Population: The Primary efficacy endpoint was analyzed using the full analysis set (FAS). The FAS included all 'Participants received Treatment' and had a baseline and at least 1 post-baseline assessment of Best Corrected Visual Acuity (BCVA).
Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of 73 to 24 (= Acuity of 20/40 to 20/320) in the study eye were included; a higher score represents better functioning.
Outcome measures
| Measure |
Control
n=154 Participants
Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
|
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4
n=154 Participants
Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
|
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8
n=151 Participants
Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
|
|---|---|---|---|
|
Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 52 - Last Observation Carried Forward (LOCF)
|
.10 letters correctly read
Standard Error 1.03
|
12.3 letters correctly read
Standard Error .76
|
10.6 letters correctly read
Standard Error .69
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: All secondary efficacy endpoints were analyzed using the full analysis set (FAS). The FAS included all 'Participants received Treatment' and had a baseline and at least 1 post-baseline assessment of Best Corrected Visual Acuity (BCVA).
Outcome measures
| Measure |
Control
n=154 Participants
Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
|
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4
n=154 Participants
Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
|
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8
n=151 Participants
Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
|
|---|---|---|---|
|
Percentage of Participants Who Gained at Least 10 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF
|
30 percentage of participants
|
100 percentage of participants
|
88 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 52Outcome measures
| Measure |
Control
n=154 Participants
Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
|
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4
n=154 Participants
Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
|
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8
n=151 Participants
Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
|
|---|---|---|---|
|
Percentage of Participants Who Gained at Least 15 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF
|
12 percentage of participants
|
64 percentage of participants
|
47 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 52Baseline ETDRS DRSS: None (level 10); Mild to moderate nonproliferative DR (levels 14, 15, 20, 35, and 43); Moderately severe/severe nonproliferative DR (levels 47 and 53); Mild/moderate/high-risk/advanced proliferative DR (levels 61, 65, 71,75, 81, and 85)
Outcome measures
| Measure |
Control
n=154 Participants
Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
|
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4
n=154 Participants
Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
|
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8
n=151 Participants
Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
|
|---|---|---|---|
|
Percentage of Participants With a ≥2-step Improvement From Baseline in the ETDRS DRSS (Diabetic Retinopathy Severity Score) as Assessed by FP (Fundus Photography) at Week 52 - LOCF
|
22 percentage of participants
|
52 percentage of participants
|
44 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 52Outcome measures
| Measure |
Control
n=154 Participants
Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
|
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4
n=154 Participants
Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
|
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8
n=151 Participants
Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
|
|---|---|---|---|
|
Change From Baseline in Central Retinal Thickness (CRT) at Week 52 as Assessed on Optical Coherence Tomography (OCT) - LOCF
|
-73.3 microns
Standard Error 12.09
|
-184.1 microns
Standard Error 6.57
|
-186.8 microns
Standard Error 6.90
|
SECONDARY outcome
Timeframe: Baseline and Week 52The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales that are all scored from 0-100. Near activities are defined as reading ordinary print in newspapers, performing work or hobbies requiring near vision, or finding something on a crowded shelf.
Outcome measures
| Measure |
Control
n=154 Participants
Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
|
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4
n=154 Participants
Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
|
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8
n=151 Participants
Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
|
|---|---|---|---|
|
Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Near Activities Subscale at Week 52 - LOCF
|
3.7 scores on a scale
Standard Error 1.55
|
8.9 scores on a scale
Standard Error 1.58
|
8.1 scores on a scale
Standard Error 1.44
|
SECONDARY outcome
Timeframe: Baseline and Week 52The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales that are all scored from 0-100. Distance activities are defined as reading street signs or names on stores, and going down stairs, steps, or curbs.
Outcome measures
| Measure |
Control
n=154 Participants
Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
|
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4
n=154 Participants
Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
|
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8
n=151 Participants
Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
|
|---|---|---|---|
|
Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Distance Activities Subscale at Week 52 - LOCF
|
4.9 scores on a scale
Standard Error 1.44
|
7.7 scores on a scale
Standard Error 1.57
|
6.5 scores on a scale
Standard Error 1.48
|
Adverse Events
Control (Week 0 to Week 100)
Serious events: 67 serious events
Other events: 91 other events
Deaths: 0 deaths
IAI;EYLEA®;BAY86-5321 2Q4 (Week 0 to Week 100)
Serious events: 67 serious events
Other events: 90 other events
Deaths: 0 deaths
IAI;EYLEA®;BAY86-5321) 2Q8 (Week 0 to Week 100)
Serious events: 56 serious events
Other events: 76 other events
Deaths: 0 deaths
Control (Week 0 to Week 148)
Serious events: 84 serious events
Other events: 134 other events
Deaths: 0 deaths
IAI;EYLEA®;BAY86-5321 2Q4 (Week 0 to Week 148)
Serious events: 85 serious events
Other events: 137 other events
Deaths: 0 deaths
IAI;EYLEA®;BAY86-5321) 2Q8 (Week 0 to Week 148)
Serious events: 75 serious events
Other events: 136 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Control (Week 0 to Week 100)
n=154 participants at risk
Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
|
IAI;EYLEA®;BAY86-5321 2Q4 (Week 0 to Week 100)
n=155 participants at risk
Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
|
IAI;EYLEA®;BAY86-5321) 2Q8 (Week 0 to Week 100)
n=152 participants at risk
Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
|
Control (Week 0 to Week 148)
n=154 participants at risk
Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
|
IAI;EYLEA®;BAY86-5321 2Q4 (Week 0 to Week 148)
n=155 participants at risk
Participants received 2mg Intravitreal aflibercept injection(IAI) every 4 weeks.
|
IAI;EYLEA®;BAY86-5321) 2Q8 (Week 0 to Week 148)
n=152 participants at risk
Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
|
|---|---|---|---|---|---|---|
|
Investigations
Troponin increased
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.8%
9/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.3%
5/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
6.5%
10/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.9%
6/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Blood and lymphatic system disorders
Nephrogenic anaemia
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Cardiac disorders
Acute myocardial infarction
|
1.9%
3/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
2.6%
4/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
2.0%
3/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Cardiac disorders
Angina pectoris
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
2.0%
3/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
2.6%
4/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Cardiac disorders
Cardiac arrest
|
1.3%
2/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.9%
3/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Cardiac disorders
Cardiac failure acute
|
2.6%
4/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
2.6%
4/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Cardiac disorders
Cardiac failure congestive
|
3.2%
5/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.8%
9/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.3%
5/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.9%
6/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
7.1%
11/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.9%
6/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Cardiac disorders
Cor pulmonale chronic
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Cardiac disorders
Coronary artery disease
|
1.3%
2/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
2.6%
4/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.2%
5/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
2.6%
4/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Investigations
Visual acuity tests abnormal
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Cardiac disorders
Coronary artery stenosis
|
1.9%
3/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
2.6%
4/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.3%
5/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.9%
3/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
2.6%
4/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.3%
5/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Cardiac disorders
Coronary ostial stenosis
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Cardiac disorders
Myocardial infarction
|
1.9%
3/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.2%
5/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
2.0%
3/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.9%
3/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
2.6%
4/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Cardiac disorders
Right ventricular failure
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Cardiac disorders
Systolic dysfunction
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Eye disorders
Cataract
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
2.6%
4/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
2.6%
4/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Eye disorders
Cataract subcapsular
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Eye disorders
Corneal epithelium defect
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Eye disorders
Diabetic retinal oedema
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Nervous system disorders
Multiple sclerosis
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Eye disorders
Hyphaema
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Eye disorders
Intraocular pressure increased
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Eye disorders
Iris neovascularisation
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Eye disorders
Lens dislocation
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Eye disorders
Macular ischaemia
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Eye disorders
Punctate keratitis
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Eye disorders
Retinal aneurysm
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Eye disorders
Retinal artery occlusion
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Eye disorders
Retinal ischaemia
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.9%
3/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Eye disorders
Retinal haemorrhage
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Eye disorders
Retinal neovascularisation
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Eye disorders
Retinal vascular disorder
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Eye disorders
Retinal tear
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Eye disorders
Retinal vein occlusion
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.9%
3/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.8%
9/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
2.6%
4/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Eye disorders
Vitreous opacities
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Gastrointestinal disorders
Diabetic gastroparesis
|
1.3%
2/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.3%
2/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.9%
3/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
2.6%
4/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Gastrointestinal disorders
Haematemesis
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Gastrointestinal disorders
Ileus
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Gastrointestinal disorders
Internal hernia
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
General disorders
Chest pain
|
1.9%
3/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
2.6%
4/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
2.6%
4/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
2.6%
4/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
General disorders
Asthenia
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.3%
2/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Gastrointestinal disorders
Volvulus of small bowel
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
General disorders
Death
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
General disorders
Device failure
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
General disorders
Device malfunction
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
General disorders
Drug withdrawal syndrome
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
General disorders
Generalised oedema
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
General disorders
Medical device complication
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
General disorders
Multi-organ failure
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
General disorders
Oedema peripheral
|
1.3%
2/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
General disorders
Pyrexia
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
General disorders
Sudden cardiac death
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Hepatobiliary disorders
Gallbladder cholesterolosis
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Infections and infestations
Abscess limb
|
1.3%
2/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Infections and infestations
Appendicitis
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Infections and infestations
Breast cellulitis
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Infections and infestations
Bronchitis
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Infections and infestations
Burn infection
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Infections and infestations
Cellulitis
|
2.6%
4/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
4.5%
7/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.3%
8/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.2%
5/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.8%
9/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.3%
8/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Infections and infestations
Diabetic foot infection
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Infections and infestations
Endocarditis bacterial
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Infections and infestations
Endophthalmitis
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Infections and infestations
Gangrene
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Infections and infestations
Gastroenteritis
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Infections and infestations
Gastroenteritis viral
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Infections and infestations
Infection
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Infections and infestations
Influenza
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Infections and infestations
Klebsiella sepsis
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Infections and infestations
Lobar pneumonia
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.9%
3/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Infections and infestations
Localised infection
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Infections and infestations
Mastoiditis
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Infections and infestations
Osteomyelitis
|
1.9%
3/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.2%
5/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.2%
5/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
4.5%
7/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
2.0%
3/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Infections and infestations
Osteomyelitis acute
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Infections and infestations
Parotitis
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Infections and infestations
Perineal abscess
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Infections and infestations
Pneumonia
|
2.6%
4/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
2.6%
4/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
2.0%
3/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
2.6%
4/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.9%
6/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
2.6%
4/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Infections and infestations
Sepsis
|
1.3%
2/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.9%
3/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Infections and infestations
Sinusitis
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Investigations
Transaminases increased
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Infections and infestations
Urinary tract infection
|
1.3%
2/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
2.6%
4/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Infections and infestations
Urosepsis
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Infections and infestations
Wound sepsis
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Injury, poisoning and procedural complications
Accident
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site haemorrhage
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Injury, poisoning and procedural complications
Arteriovenous graft site haemorrhage
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Injury, poisoning and procedural complications
Cataract operation complication
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Injury, poisoning and procedural complications
Cataract traumatic
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Injury, poisoning and procedural complications
Clavical fracture
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Injury, poisoning and procedural complications
Fall
|
1.3%
2/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.9%
3/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.3%
5/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.9%
3/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.9%
3/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.3%
5/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Investigations
Blood creatinine increased
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Investigations
Haematocrit decreased
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Investigations
Heart rate increased
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Investigations
Intraocular pressure increased
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
2.6%
4/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.9%
3/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
2.6%
4/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Metabolism and nutrition disorders
Diabetes with hyperosmolarity
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.6%
4/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.9%
3/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.9%
6/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
2.6%
4/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.2%
5/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.9%
6/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Metabolism and nutrition disorders
Ketosis
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Musculoskeletal and connective tissue disorders
Neuropathic arthropathy
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.9%
3/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
2.6%
4/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.9%
3/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.2%
5/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Musculoskeletal and connective tissue disorders
Tendon disorder
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Musculoskeletal and connective tissue disorders
Tendonitits
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer stage II
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.9%
3/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.9%
3/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myelomonocytic leukaemia
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma stage III
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
2.0%
3/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
2.0%
3/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.9%
3/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.9%
3/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer recurrent
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal neoplasm
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Nervous system disorders
Autonomic nervous system imbalance
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Nervous system disorders
Brain injury
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Nervous system disorders
Brain stem stroke
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.3%
2/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.2%
5/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.3%
5/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
2.6%
4/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.2%
5/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.3%
5/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Nervous system disorders
Cognitive disorder
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Nervous system disorders
Coma
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Nervous system disorders
Diabetic coma
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Nervous system disorders
Headache
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Nervous system disorders
Hemianopia homonymous
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Nervous system disorders
Hypertensive encephalopathy
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Nervous system disorders
Normal pressure hydrocephalus
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Nervous system disorders
Sedation
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Nervous system disorders
Syncope
|
1.3%
2/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.9%
3/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.9%
3/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Nervous system disorders
Thalamic infarction
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Nervous system disorders
Toxic encephalopathy
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Nervous system disorders
Transient ischaemic attack
|
1.9%
3/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.9%
3/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Nervous system disorders
Visual field defect
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Psychiatric disorders
Affective disorder
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Psychiatric disorders
Depression
|
1.3%
2/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Psychiatric disorders
Schizoaffective disorder
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Renal and urinary disorders
Bladder outlet obstruction
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Renal and urinary disorders
Haematuria
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Renal and urinary disorders
Intercapillary glomerulosclerosis
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Renal and urinary disorders
Nephropathy
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Renal and urinary disorders
Nephropathy toxic
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Renal and urinary disorders
Nephrosclerosis
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Renal and urinary disorders
Renal failure
|
2.6%
4/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.2%
5/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.2%
5/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.2%
5/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Renal and urinary disorders
Renal failure acute
|
4.5%
7/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.9%
6/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.9%
6/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.8%
9/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
6.5%
10/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.3%
8/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Renal and urinary disorders
Renal failure chronic
|
1.3%
2/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
2.6%
4/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
2.0%
3/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
2.6%
4/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.2%
5/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
2.0%
3/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Renal and urinary disorders
Renal impairment
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Reproductive system and breast disorders
Breast mass
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Reproductive system and breast disorders
Labia enlarged
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Reproductive system and breast disorders
Uterine mass
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.3%
2/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.9%
3/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Skin and subcutaneous tissue disorders
Hypertrophic scar
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Surgical and medical procedures
Arteriovenous fistula operation
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Surgical and medical procedures
Coronary artery bypass
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Surgical and medical procedures
Foot amputation
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Vascular disorders
Haematoma
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Vascular disorders
Hypertension
|
1.9%
3/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.2%
5/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.9%
3/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.9%
6/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Vascular disorders
Hypertensive crisis
|
1.3%
2/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Vascular disorders
Hypertensive emergency
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Vascular disorders
Hypotension
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Vascular disorders
Hypovolaemic shock
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Vascular disorders
Intermittent claudication
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Vascular disorders
Malignant hypertension
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Vascular disorders
Orthostatic hypotension
|
1.3%
2/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Vascular disorders
Peripheral artery stenosis
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.00%
0/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
Other adverse events
| Measure |
Control (Week 0 to Week 100)
n=154 participants at risk
Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
|
IAI;EYLEA®;BAY86-5321 2Q4 (Week 0 to Week 100)
n=155 participants at risk
Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
|
IAI;EYLEA®;BAY86-5321) 2Q8 (Week 0 to Week 100)
n=152 participants at risk
Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
|
Control (Week 0 to Week 148)
n=154 participants at risk
Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
|
IAI;EYLEA®;BAY86-5321 2Q4 (Week 0 to Week 148)
n=155 participants at risk
Participants received 2mg Intravitreal aflibercept injection(IAI) every 4 weeks.
|
IAI;EYLEA®;BAY86-5321) 2Q8 (Week 0 to Week 148)
n=152 participants at risk
Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
7.8%
12/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
12.9%
20/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
7.9%
12/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
9.7%
15/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
17.4%
27/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
13.2%
20/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Psychiatric disorders
Anxiety
|
4.5%
7/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
7.7%
12/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
2.6%
4/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.8%
9/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
8.4%
13/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.3%
5/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.8%
9/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.2%
8/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.3%
8/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
7.8%
12/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
8.4%
13/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.9%
9/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
3.9%
6/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.2%
5/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
6.6%
10/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
4.5%
7/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.9%
6/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
7.9%
12/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.2%
8/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
12.9%
20/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.9%
6/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
7.1%
11/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
14.2%
22/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.9%
9/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Investigations
Blood creatine phosphokinase increased
|
7.8%
12/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
4.5%
7/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
2.6%
4/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
7.8%
12/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.8%
9/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
2.6%
4/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Investigations
Blood glucose increased
|
3.9%
6/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.8%
9/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
7.2%
11/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.8%
9/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
9.7%
15/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
10.5%
16/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Investigations
Blood pressure increased
|
6.5%
10/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.8%
9/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
4.6%
7/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
9.7%
15/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
7.7%
12/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.3%
8/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Investigations
Blood pressure systolic increased
|
1.3%
2/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.3%
5/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
2.6%
4/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.3%
8/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Infections and infestations
Bronchitis
|
7.1%
11/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
7.7%
12/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
2.6%
4/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
8.4%
13/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
7.7%
12/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
4.6%
7/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Cardiac disorders
Cardiac failure congestive
|
3.9%
6/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
7.7%
12/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.9%
9/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
2.6%
4/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.9%
6/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.3%
8/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Eye disorders
Cataract
|
10.4%
16/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
13.5%
21/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
8.6%
13/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
15.6%
24/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
18.1%
28/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
13.8%
21/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Eye disorders
Cataract cortical
|
5.2%
8/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
4.6%
7/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.2%
8/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.2%
5/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
4.6%
7/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Eye disorders
Cataract nuclear
|
1.3%
2/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.9%
6/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.2%
8/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Eye disorders
Cataract subcapsular
|
4.5%
7/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.9%
6/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.3%
8/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
6.5%
10/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
7.7%
12/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
6.6%
10/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Infections and infestations
Cellulitis
|
4.5%
7/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
6.5%
10/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
7.9%
12/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
4.5%
7/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.2%
5/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.3%
8/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
General disorders
Chest pain
|
5.8%
9/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.9%
3/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.3%
5/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.8%
9/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.9%
3/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.3%
5/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Eye disorders
Conjunctival haemorrhage
|
34.4%
53/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
40.6%
63/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
31.6%
48/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
35.7%
55/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
40.6%
63/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
32.9%
50/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Gastrointestinal disorders
Constipation
|
5.8%
9/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
7.1%
11/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.3%
5/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
9.1%
14/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
9.7%
15/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.9%
6/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Eye disorders
Corneal abrasion
|
3.9%
6/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
2.6%
4/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.9%
6/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.8%
9/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
4.5%
7/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.9%
6/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.4%
13/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
11.6%
18/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
11.2%
17/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
10.4%
16/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
13.5%
21/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
13.2%
20/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Psychiatric disorders
Depression
|
4.5%
7/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
4.5%
7/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
2.6%
4/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.8%
9/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.9%
6/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
2.6%
4/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
13.0%
20/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
8.4%
13/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
12.5%
19/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
18.2%
28/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
14.8%
23/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
16.4%
25/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Eye disorders
Diabetic retinal oedema
|
12.3%
19/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
14.2%
22/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
11.8%
18/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
16.9%
26/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
18.7%
29/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
15.1%
23/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Eye disorders
Diabetic retinopathy
|
7.1%
11/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.2%
8/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
9.2%
14/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
10.4%
16/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.2%
8/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
11.8%
18/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.4%
13/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
9.0%
14/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.9%
6/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
9.7%
15/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
12.3%
19/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
4.6%
7/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Nervous system disorders
Dizziness
|
5.2%
8/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
4.5%
7/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.9%
9/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.8%
9/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.8%
9/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
6.6%
10/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Immune system disorders
Drug hypersensitivity
|
1.3%
2/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.2%
5/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
2.0%
3/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.9%
6/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.2%
8/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
2.0%
3/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Eye disorders
Dry eye
|
6.5%
10/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
9.0%
14/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
4.6%
7/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
7.8%
12/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
10.3%
16/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.9%
9/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.9%
6/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
7.7%
12/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
7.2%
11/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
4.5%
7/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
9.7%
15/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
8.6%
13/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Infections and infestations
Ear infection
|
2.6%
4/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.9%
3/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.9%
6/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.9%
6/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.2%
5/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.9%
9/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Eye disorders
Eye irritation
|
4.5%
7/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.9%
6/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
4.6%
7/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.2%
8/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.8%
9/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.3%
8/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Eye disorders
Eye pain
|
4.5%
7/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
7.1%
11/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.9%
9/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
6.5%
10/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
8.4%
13/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
9.2%
14/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Injury, poisoning and procedural complications
Fall
|
5.2%
8/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
4.5%
7/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
7.9%
12/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
7.8%
12/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
4.5%
7/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
9.2%
14/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
General disorders
Fatigue
|
2.6%
4/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.2%
8/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
2.0%
3/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.2%
5/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.8%
9/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
2.0%
3/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Eye disorders
Foreign body sensation in eyes
|
5.2%
8/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.2%
8/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.3%
5/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.2%
8/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.8%
9/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.9%
6/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Infections and infestations
Gastroenteritis viral
|
1.3%
2/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.9%
6/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.9%
3/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.3%
8/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.8%
9/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
6.5%
10/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
2.6%
4/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
9.1%
14/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
8.4%
13/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
6.6%
10/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Investigations
Glycosylated haemoglobin increased
|
4.5%
7/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
4.5%
7/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
8.6%
13/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
6.5%
10/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
6.5%
10/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
10.5%
16/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Nervous system disorders
Headache
|
12.3%
19/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
11.6%
18/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
4.6%
7/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
14.3%
22/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
13.5%
21/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
8.6%
13/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
6.5%
10/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.2%
5/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
2.0%
3/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
8.4%
13/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.9%
6/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
2.6%
4/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.8%
9/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.8%
9/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.9%
6/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.8%
9/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
7.1%
11/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.3%
8/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Vascular disorders
Hypertension
|
31.8%
49/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
26.5%
41/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
27.6%
42/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
36.4%
56/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
32.9%
51/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
32.2%
49/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.9%
3/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.2%
8/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.3%
5/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
6.5%
10/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
9.0%
14/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.9%
9/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Endocrine disorders
Hypothyroidism
|
4.5%
7/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
2.6%
4/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.3%
5/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.2%
8/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
2.6%
4/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.3%
5/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Infections and infestations
Influenza
|
5.8%
9/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
4.5%
7/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
10.5%
16/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
9.7%
15/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.8%
9/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
14.5%
22/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Investigations
Intraocular pressure increased
|
1.3%
2/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
7.7%
12/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
6.6%
10/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.9%
6/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
10.3%
16/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
6.6%
10/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Eye disorders
Lacrimation increased
|
3.9%
6/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
4.5%
7/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.9%
6/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
4.5%
7/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.2%
8/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.3%
8/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Infections and infestations
Nasopharyngitis
|
11.0%
17/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
11.0%
17/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
12.5%
19/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
14.9%
23/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
14.2%
22/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
15.8%
24/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Infections and infestations
Localised infection
|
3.2%
5/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
6.5%
10/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.3%
5/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
7.1%
11/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
7.1%
11/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.3%
5/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Eye disorders
Macular fibrosis
|
7.8%
12/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
7.1%
11/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
10.5%
16/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
12.3%
19/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
9.0%
14/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
15.1%
23/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Eye disorders
Macular oedema
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
2.6%
4/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.9%
6/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
4.5%
7/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.9%
6/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.9%
9/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.2%
8/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.2%
5/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.8%
9/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.9%
6/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
2.6%
4/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Gastrointestinal disorders
Nausea
|
9.7%
15/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
12.3%
19/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
7.2%
11/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
10.4%
16/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
13.5%
21/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
10.5%
16/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Nervous system disorders
Neuropathy peripheral
|
3.2%
5/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.2%
5/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
4.6%
7/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.9%
6/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.9%
6/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.3%
8/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Eye disorders
Ocular hyperaemia
|
7.8%
12/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.9%
6/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.9%
6/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
7.8%
12/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.9%
6/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
4.6%
7/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
General disorders
Oedema peripheral
|
5.2%
8/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
9.7%
15/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
9.9%
15/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
7.1%
11/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
12.3%
19/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
10.5%
16/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
4.5%
7/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
4.5%
7/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.3%
5/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.9%
6/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
2.6%
4/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
7.9%
12/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Eye disorders
Pain in extremity
|
6.5%
10/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.2%
8/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.3%
5/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
8.4%
13/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
7.7%
12/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
4.6%
7/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Eye disorders
Photopsia
|
4.5%
7/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.66%
1/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.2%
8/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Infections and infestations
Pneumonia
|
4.5%
7/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.2%
8/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
4.6%
7/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
2.6%
4/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.8%
9/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.9%
6/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Eye disorders
Posterior capsule opacification
|
7.8%
12/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
4.5%
7/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.3%
8/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
10.4%
16/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.8%
9/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
9.9%
15/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.2%
8/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.2%
8/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
2.0%
3/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Eye disorders
Punctate keratitis
|
0.65%
1/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.2%
5/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
4.6%
7/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.9%
3/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.2%
8/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
4.6%
7/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
General disorders
Pyrexia
|
1.3%
2/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
4.5%
7/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.9%
6/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.2%
5/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
6.5%
10/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
4.6%
7/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Renal and urinary disorders
Renal failure acute
|
7.1%
11/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
6.5%
10/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.9%
9/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.2%
5/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.2%
8/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
4.6%
7/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Renal and urinary disorders
Renal failure chronic
|
2.6%
4/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.8%
9/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.3%
8/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.2%
5/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.8%
9/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.3%
8/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Eye disorders
Retinal exudates
|
7.1%
11/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
7.7%
12/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.9%
6/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
9.7%
15/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
9.7%
15/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.3%
8/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Eye disorders
Retinal haemorrhage
|
6.5%
10/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
7.1%
11/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.3%
5/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
8.4%
13/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
10.3%
16/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.9%
6/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Eye disorders
Retinal neovascularisation
|
7.8%
12/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.9%
3/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
2.0%
3/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
7.8%
12/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.9%
3/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
2.0%
3/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Eye disorders
Retinal pigment epitheliopathy
|
1.9%
3/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.2%
5/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.3%
8/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.9%
3/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.9%
6/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.9%
9/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Immune system disorders
Seasonal allergy
|
5.2%
8/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.9%
6/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.9%
9/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.8%
9/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.8%
9/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
7.9%
12/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Infections and infestations
Sinusitis
|
7.8%
12/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
8.4%
13/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
7.9%
12/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
11.7%
18/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
9.0%
14/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
8.6%
13/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
3.9%
6/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.8%
9/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.3%
5/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.8%
9/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
7.7%
12/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.9%
6/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.4%
13/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
7.1%
11/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
9.9%
15/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
10.4%
16/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
8.4%
13/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
11.2%
17/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Infections and infestations
Urinary tract infection
|
9.1%
14/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
11.0%
17/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
17.1%
26/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
13.0%
20/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
19.4%
30/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
21.1%
32/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Investigations
Urine protein/ creatinine ratio increased
|
5.2%
8/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.2%
5/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
1.3%
2/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.8%
9/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.2%
8/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
2.0%
3/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Eye disorders
Vision blurred
|
3.2%
5/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.2%
8/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.3%
5/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
4.5%
7/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
7.1%
11/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
4.6%
7/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Eye disorders
Visual Impairment
|
4.5%
7/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
2.0%
3/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.2%
8/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
0.65%
1/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
2.0%
3/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Eye disorders
Visual acuity reduced
|
7.1%
11/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
4.5%
7/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
6.6%
10/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
9.1%
14/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
6.5%
10/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
7.9%
12/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
4.5%
7/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.9%
6/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.3%
5/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
4.5%
7/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.2%
8/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
4.6%
7/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Eye disorders
Vitreous detachment
|
9.7%
15/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
9.0%
14/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
14.5%
22/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
13.0%
20/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
12.9%
20/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
16.4%
25/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Eye disorders
Vitreous floaters
|
9.1%
14/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
13.5%
21/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
11.2%
17/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
10.4%
16/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
14.8%
23/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
13.8%
21/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Eye disorders
Vitreous haemorrhage
|
7.1%
11/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.2%
8/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.3%
5/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
12.3%
19/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
7.1%
11/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
4.6%
7/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
|
Gastrointestinal disorders
Vomiting
|
4.5%
7/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
9.0%
14/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
2.0%
3/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
5.8%
9/154 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
10.3%
16/155 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
3.3%
5/152 • From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 100; From the first study drug injection until 30 days after the last study drug injection at the latest from week 0 to week 148.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Not less than 45 days prior to submission of any (M)anuscript, (I)nstitution shall, or cause PI to, provide (S)ponsor a copy of (M). (I) to consider comments submitted by (S), \& to delete confidential information upon (S) request. At (S)'s request, (I) to delay publication for an additional 60 days to allow filing of patent applications. (I) \& PI agree to delay publication, prior to (M) summarizing data from all sites, unless no (M) is published prior to first anniversary of final study report.
- Publication restrictions are in place
Restriction type: OTHER