Trial Outcomes & Findings for Safety and Efficacy of Abicipar Pegol in Participants With Neovascular Age-related Macular Degeneration (NCT NCT02462486)
NCT ID: NCT02462486
Last Updated: 2020-07-30
Results Overview
Stable vision was defined as vision loss of fewer than 15 letters in Best-corrected Visual Acuity (BCVA) from baseline. BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The percentage of participants with a BCVA loss of fewer than 15 letters are reported. Study eye was defined as the eye that meets the entry criteria. If both the eyes met all of the entry criteria, the eye with worse BCVA at baseline (Day 1) was selected. If BCVA values for both eyes were identical then participant had to select the non-dominant eye, or else right eye was selected as study eye.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
949 participants
Primary outcome timeframe
Baseline to Week 52
Results posted on
2020-07-30
Participant Flow
Participant milestones
| Measure |
Abicipar Pegol 2 mg (2Q8)
Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, and Week 8, followed by injections every 8 weeks through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.
|
Abicipar Pegol 2 mg (2Q12)
Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, and Week 12, followed by injections every 12 weeks through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.
|
Ranibizumab (rQ4)
Ranibizumab (Lucentis®) was administered to the study eye by intravitreal injection every 4 weeks from Day 1 through Week 96.
|
|---|---|---|---|
|
Overall Study
STARTED
|
316
|
315
|
318
|
|
Overall Study
COMPLETED
|
222
|
223
|
266
|
|
Overall Study
NOT COMPLETED
|
94
|
92
|
52
|
Reasons for withdrawal
| Measure |
Abicipar Pegol 2 mg (2Q8)
Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, and Week 8, followed by injections every 8 weeks through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.
|
Abicipar Pegol 2 mg (2Q12)
Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, and Week 12, followed by injections every 12 weeks through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.
|
Ranibizumab (rQ4)
Ranibizumab (Lucentis®) was administered to the study eye by intravitreal injection every 4 weeks from Day 1 through Week 96.
|
|---|---|---|---|
|
Overall Study
Screen Failure:Missed Exclusion Criteria
|
1
|
1
|
3
|
|
Overall Study
Adverse Event
|
53
|
48
|
21
|
|
Overall Study
Lack of Efficacy
|
6
|
12
|
3
|
|
Overall Study
Lost to Follow-up
|
3
|
4
|
2
|
|
Overall Study
Withdrawal by Subject
|
25
|
22
|
19
|
|
Overall Study
Protocol Violation
|
3
|
1
|
1
|
|
Overall Study
Reason not Specified
|
3
|
4
|
3
|
Baseline Characteristics
Per Protocol (PP) population included all randomized and treated participants without any protocol deviations that impacted the primary efficacy variable and with treatment compliance to represent the intended regimen adequately.
Baseline characteristics by cohort
| Measure |
Abicipar Pegol 2 mg (2Q8)
n=316 Participants
Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, and Week 8, followed by injections every 8 weeks through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.
|
Abicipar Pegol 2 mg (2Q12)
n=315 Participants
Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, and Week 12, followed by injections every 12 weeks through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.
|
Ranibizumab (rQ4)
n=318 Participants
Ranibizumab (Lucentis®) was administered to the study eye by intravitreal injection every 4 weeks from Day 1 through Week 96.
|
Total
n=949 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
75.9 years
STANDARD_DEVIATION 8.6 • n=316 Participants
|
76.2 years
STANDARD_DEVIATION 8.3 • n=315 Participants
|
75.9 years
STANDARD_DEVIATION 8.4 • n=318 Participants
|
76.0 years
STANDARD_DEVIATION 8.4 • n=949 Participants
|
|
Sex: Female, Male
Female
|
179 Participants
n=316 Participants
|
174 Participants
n=315 Participants
|
185 Participants
n=318 Participants
|
538 Participants
n=949 Participants
|
|
Sex: Female, Male
Male
|
137 Participants
n=316 Participants
|
141 Participants
n=315 Participants
|
133 Participants
n=318 Participants
|
411 Participants
n=949 Participants
|
|
Race/Ethnicity, Customized
White
|
266 Participants
n=316 Participants
|
266 Participants
n=315 Participants
|
264 Participants
n=318 Participants
|
796 Participants
n=949 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 Participants
n=316 Participants
|
4 Participants
n=315 Participants
|
3 Participants
n=318 Participants
|
9 Participants
n=949 Participants
|
|
Race/Ethnicity, Customized
Asian
|
39 Participants
n=316 Participants
|
35 Participants
n=315 Participants
|
41 Participants
n=318 Participants
|
115 Participants
n=949 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
7 Participants
n=316 Participants
|
8 Participants
n=315 Participants
|
9 Participants
n=318 Participants
|
24 Participants
n=949 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=316 Participants
|
0 Participants
n=315 Participants
|
0 Participants
n=318 Participants
|
2 Participants
n=949 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
0 Participants
n=316 Participants
|
1 Participants
n=315 Participants
|
1 Participants
n=318 Participants
|
2 Participants
n=949 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=316 Participants
|
1 Participants
n=315 Participants
|
0 Participants
n=318 Participants
|
1 Participants
n=949 Participants
|
|
Best Corrected Visual Acuity (BCVA) for Per Protocol Population
|
57.8 letters
STANDARD_DEVIATION 12.1 • n=267 Participants • Per Protocol (PP) population included all randomized and treated participants without any protocol deviations that impacted the primary efficacy variable and with treatment compliance to represent the intended regimen adequately.
|
56.3 letters
STANDARD_DEVIATION 12.5 • n=265 Participants • Per Protocol (PP) population included all randomized and treated participants without any protocol deviations that impacted the primary efficacy variable and with treatment compliance to represent the intended regimen adequately.
|
57.0 letters
STANDARD_DEVIATION 12.3 • n=299 Participants • Per Protocol (PP) population included all randomized and treated participants without any protocol deviations that impacted the primary efficacy variable and with treatment compliance to represent the intended regimen adequately.
|
57.0 letters
STANDARD_DEVIATION 12.3 • n=831 Participants • Per Protocol (PP) population included all randomized and treated participants without any protocol deviations that impacted the primary efficacy variable and with treatment compliance to represent the intended regimen adequately.
|
|
BCVA for ITT Population
|
57.2 letters
STANDARD_DEVIATION 12.3 • n=316 Participants
|
56.4 letters
STANDARD_DEVIATION 12.5 • n=315 Participants
|
57.1 letters
STANDARD_DEVIATION 12.3 • n=318 Participants
|
56.9 letters
STANDARD_DEVIATION 12.4 • n=949 Participants
|
|
Central Retinal Thickness (CRT)
|
380.3 microns
STANDARD_DEVIATION 117.9 • n=316 Participants • Number analyzed is the number of participants with data available at the Baseline.
|
378.2 microns
STANDARD_DEVIATION 123.8 • n=314 Participants • Number analyzed is the number of participants with data available at the Baseline.
|
382.4 microns
STANDARD_DEVIATION 130.3 • n=318 Participants • Number analyzed is the number of participants with data available at the Baseline.
|
380.3 microns
STANDARD_DEVIATION 124.0 • n=948 Participants • Number analyzed is the number of participants with data available at the Baseline.
|
|
National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25)
|
78.4 score on a scale
n=316 Participants
|
78.3 score on a scale
n=315 Participants
|
77.3 score on a scale
n=318 Participants
|
78 score on a scale
n=949 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 52Population: Per Protocol (PP) population included all randomized and treated participants without any protocol deviations that impacted the primary efficacy variable and with treatment compliance to represent the intended regimen adequately.
Stable vision was defined as vision loss of fewer than 15 letters in Best-corrected Visual Acuity (BCVA) from baseline. BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The percentage of participants with a BCVA loss of fewer than 15 letters are reported. Study eye was defined as the eye that meets the entry criteria. If both the eyes met all of the entry criteria, the eye with worse BCVA at baseline (Day 1) was selected. If BCVA values for both eyes were identical then participant had to select the non-dominant eye, or else right eye was selected as study eye.
Outcome measures
| Measure |
Abicipar Pegol 2 mg (2Q8)
n=267 Participants
Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, and Week 8, followed by injections every 8 weeks through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.
|
Abicipar Pegol 2 mg (2Q12)
n=265 Participants
Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, and Week 12, followed by injections every 12 weeks through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.
|
Ranibizumab (rQ4)
n=299 Participants
Ranibizumab (Lucentis®) was administered to the study eye by intravitreal injection every 4 weeks from Day 1 through Week 96.
|
|---|---|---|---|
|
Percentage of Participants With Stable Vision at Week 52
|
94.8 percentage of participants
|
91.3 percentage of participants
|
96.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: PP population included all randomized and treated participants without any protocol deviations that impacted the primary efficacy variable and with treatment compliance to represent the intended regimen adequately. Number of participants analyzed was based on observed data; missing data were not imputed.
BCVA was measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. Mixed-effect model for repeated measures (MMRM) analysis was used. Study eye is defined as the eye that meets the entry criteria. If both the eyes met all of the entry criteria, the eye with worse BCVA at baseline (Day 1) was selected. If BCVA values for both eyes were identical then participant had to select the non-dominant eye, or else right eye was selected as study eye.
Outcome measures
| Measure |
Abicipar Pegol 2 mg (2Q8)
n=248 Participants
Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, and Week 8, followed by injections every 8 weeks through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.
|
Abicipar Pegol 2 mg (2Q12)
n=251 Participants
Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, and Week 12, followed by injections every 12 weeks through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.
|
Ranibizumab (rQ4)
n=287 Participants
Ranibizumab (Lucentis®) was administered to the study eye by intravitreal injection every 4 weeks from Day 1 through Week 96.
|
|---|---|---|---|
|
Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) in the Study Eye at Week 52
|
8.3 letters
Standard Deviation 14.3
|
7.3 letters
Standard Deviation 13.8
|
8.3 letters
Standard Deviation 11.8
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: Intent-to-treat (ITT) Population included all randomized participants. Number of participants analyzed was based on observed data; missing data were not imputed.
CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system that provides high-resolution imaging sections of the retina. SD-OCT is performed in the study eye after pupil dilation. A negative change from Baseline indicates improvement and a positive change from baseline indicates worsening. Study eye is defined as the eye that meets the entry criteria. If both the eyes met all of the entry criteria, the eye with worse BCVA at baseline (Day 1) was selected. If BCVA values for both eyes were identical then participant had to select the non-dominant eye, or else right eye was selected as study eye. MMRM analysis was used.
Outcome measures
| Measure |
Abicipar Pegol 2 mg (2Q8)
n=248 Participants
Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, and Week 8, followed by injections every 8 weeks through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.
|
Abicipar Pegol 2 mg (2Q12)
n=256 Participants
Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, and Week 12, followed by injections every 12 weeks through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.
|
Ranibizumab (rQ4)
n=286 Participants
Ranibizumab (Lucentis®) was administered to the study eye by intravitreal injection every 4 weeks from Day 1 through Week 96.
|
|---|---|---|---|
|
Mean Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye at Week 52
|
-146.8 microns
Standard Deviation 118.1
|
-141.7 microns
Standard Deviation 127.1
|
-147.1 microns
Standard Deviation 126.2
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: ITT Population included all randomized participants.
BCVA is measured using an eye chart and is reported as the number of letters read correctly using the Early Treatment of Diabetic Retinopathy Study (ETDRS) Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The percentage of participants with a BCVA gain of more than 15 letters are noted. Study eye is defined as the eye that meets the entry criteria. If both the eyes met all of the entry criteria, the eye with worse BCVA at baseline (Day 1) was selected. If BCVA values for both eyes were identical then participant had to select the non-dominant eye, or else right eye was selected as study eye.
Outcome measures
| Measure |
Abicipar Pegol 2 mg (2Q8)
n=316 Participants
Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, and Week 8, followed by injections every 8 weeks through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.
|
Abicipar Pegol 2 mg (2Q12)
n=315 Participants
Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, and Week 12, followed by injections every 12 weeks through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.
|
Ranibizumab (rQ4)
n=318 Participants
Ranibizumab (Lucentis®) was administered to the study eye by intravitreal injection every 4 weeks from Day 1 through Week 96.
|
|---|---|---|---|
|
Percentage of Participants With BCVA Gain of More Than 15 Letters From Baseline in the Study Eye at Week 52
|
28.2 percentage of participants
|
24.4 percentage of participants
|
26.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: ITT population included all randomized participants. Number of participants analyzed was based on observed data; missing data were not imputed.
NEI-VFQ-25 consists of 25 vision-targeted questions that represent 11 vision-related quality of life subscales and one general health item. Responses of individual participants were recorded as scores that ranged between 0 (worst) to 100 (best vision related function) with higher scale indicating better vision. Overall composite score is then calculated by averaging over all 11 vision-targeted subscale scores, excluding general health score. Overall composite score was calculated based on mean of non-missing subscales. Study eye: eye that meets entry criteria. If both eyes met all of entry criteria, eye with worse BCVA at baseline (day 1) was selected. If BCVA values for both eyes were identical then participant had to select non-dominant eye, or else right eye was selected as study eye. A positive change from baseline indicates improvement. MMRM analysis was used.
Outcome measures
| Measure |
Abicipar Pegol 2 mg (2Q8)
n=254 Participants
Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, and Week 8, followed by injections every 8 weeks through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.
|
Abicipar Pegol 2 mg (2Q12)
n=261 Participants
Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, and Week 12, followed by injections every 12 weeks through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.
|
Ranibizumab (rQ4)
n=287 Participants
Ranibizumab (Lucentis®) was administered to the study eye by intravitreal injection every 4 weeks from Day 1 through Week 96.
|
|---|---|---|---|
|
Mean Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) Composite Score at Week 52
|
2.8 scores on a scale
Standard Error 0.7
|
2.4 scores on a scale
Standard Error 0.7
|
4.4 scores on a scale
Standard Error 0.7
|
Adverse Events
Abicipar Pegol 2 mg (2Q8)
Serious events: 94 serious events
Other events: 168 other events
Deaths: 11 deaths
Abicipar Pegol 2 mg (2Q12)
Serious events: 83 serious events
Other events: 166 other events
Deaths: 6 deaths
Ranibizumab (rQ4)
Serious events: 78 serious events
Other events: 166 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Abicipar Pegol 2 mg (2Q8)
n=313 participants at risk
Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, and Week 8, followed by injections every 8 weeks through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.
|
Abicipar Pegol 2 mg (2Q12)
n=314 participants at risk
Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, and Week 12, followed by injections every 12 weeks through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.
|
Ranibizumab (rQ4)
n=315 participants at risk
Ranibizumab (Lucentis®) was administered to the study eye by intravitreal injection every 4 weeks from Day 1 through Week 96.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.96%
3/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
1.6%
5/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
1.6%
5/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Cardiac disorders
Atrial fibrillation
|
0.64%
2/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.96%
3/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
1.6%
5/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Cardiac disorders
Angina pectoris
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.64%
2/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.95%
3/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Cardiac disorders
Coronary artery disease
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.63%
2/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.63%
2/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.63%
2/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
1.3%
4/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Cardiac disorders
Cardiac arrest
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Cardiac disorders
Myocardial oedema
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Cardiac disorders
Cardiac failure
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.64%
2/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.64%
2/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Cardiac disorders
Aortic valve disease
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Cardiac disorders
Sinus bradycardia
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Cardiac disorders
Tachycardia
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Ear and labyrinth disorders
Meniere's disease
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Retinal haemorrhage
|
0.64%
2/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
1.6%
5/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Retinal detachment
|
0.96%
3/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.63%
2/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Cataract
|
0.64%
2/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.96%
3/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.64%
2/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Retinal fibrosis
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Retinal pigment epithelial tear
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Uveitis
|
2.2%
7/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
1.3%
4/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Retinal vasculitis
|
1.3%
4/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
1.3%
4/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Visual acuity reduced
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.96%
3/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Vitritis
|
1.3%
4/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Iridocyclitis
|
0.64%
2/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Retinal artery occlusion
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Age-related macular degeneration
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Autoimmune uveitis
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Choroidal neovascularisation
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Neovascular age-related macular degeneration
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Retinal vein occlusion
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Anterior chamber inflammation
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Keratitis
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Macular hole
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Serous retinal detachment
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Gastrointestinal disorders
Alcoholic pancreatitis
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.64%
2/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Gastrointestinal disorders
Constipation
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Gastrointestinal disorders
Gastrointestinal ulcer haemorrhage
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Gastrointestinal disorders
Pharyngo-oesophageal diverticulum
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
General disorders
Peripheral swelling
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
General disorders
Asthenia
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
General disorders
Death
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
General disorders
Non-cardiac chest pain
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Immune system disorders
Drug hypersensitivity
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Pneumonia
|
1.3%
4/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.96%
3/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
2.5%
8/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.63%
2/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Endophthalmitis
|
1.6%
5/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
1.3%
4/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Sepsis
|
0.64%
2/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Influenza
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Arteritis infective
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Enterocolitis viral
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Infective aortitis
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Cellulitis
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Pneumonia escherichia
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Septic shock
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Bronchitis
|
0.96%
3/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Urinary tract infection
|
0.64%
2/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Cellulitis staphylococcal
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Diarrhoea infectious
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Gastroenteritis
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Infectious colitis
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Pulmonary sepsis
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Respiratory tract infection
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Injury, poisoning and procedural complications
Fall
|
0.64%
2/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.96%
3/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.95%
3/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.63%
2/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Injury, poisoning and procedural complications
Scrotal haematoma
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Injury, poisoning and procedural complications
Synovial rupture
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Injury, poisoning and procedural complications
Traumatic liver injury
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.64%
2/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Injury, poisoning and procedural complications
Periprosthetic fracture
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Injury, poisoning and procedural complications
Skin wound
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.64%
2/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.64%
2/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.64%
2/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Investigations
Troponin increased
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Investigations
Intraocular pressure increased
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.64%
2/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Investigations
Heart rate decreased
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Investigations
Monoclonal immunoglobulin present
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Investigations
Blood glucose abnormal
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Investigations
Blood pressure increased
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Investigations
Pulmonary function test decreased
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Investigations
Urine electrolytes decreased
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.64%
2/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.64%
2/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.64%
2/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.63%
2/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Musculoskeletal and connective tissue disorders
Bone loss
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Musculoskeletal and connective tissue disorders
Foot fracture
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.64%
2/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.96%
3/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
1.9%
6/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.63%
2/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.63%
2/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.64%
2/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer metastatic
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Keratoacanthoma
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Retroperitoneal neoplasm metastatic
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.64%
2/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer metastatic
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma stage IV
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer metastatic
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of head and neck
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.64%
2/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oropharyngeal squamous cell carcinoma
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.95%
3/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.96%
3/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Nervous system disorders
Syncope
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Nervous system disorders
Brain stem stroke
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Nervous system disorders
Piriformis syndrome
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Nervous system disorders
Seizure
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Nervous system disorders
Optic neuritis
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Nervous system disorders
Peroneal nerve palsy
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Nervous system disorders
Vertebral artery occlusion
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Nervous system disorders
Carotid artery occlusion
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Nervous system disorders
Cerebral infarction
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Nervous system disorders
Headache
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Nervous system disorders
Ischaemic stroke
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Nervous system disorders
Speech disorder
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Nervous system disorders
Vascular dementia
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Psychiatric disorders
Depression
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Renal and urinary disorders
Haematuria
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.64%
2/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.96%
3/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.95%
3/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.64%
2/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.63%
2/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.64%
2/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.63%
2/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.64%
2/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.64%
2/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Vascular disorders
Hypertension
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.64%
2/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.63%
2/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Vascular disorders
Haematoma
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.64%
2/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Vascular disorders
Blood pressure inadequately controlled
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Vascular disorders
Hypotension
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Vascular disorders
Deep vein thrombosis
|
0.64%
2/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Vascular disorders
Lymphoedema
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.32%
1/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
Other adverse events
| Measure |
Abicipar Pegol 2 mg (2Q8)
n=313 participants at risk
Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, and Week 8, followed by injections every 8 weeks through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.
|
Abicipar Pegol 2 mg (2Q12)
n=314 participants at risk
Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, and Week 12, followed by injections every 12 weeks through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.
|
Ranibizumab (rQ4)
n=315 participants at risk
Ranibizumab (Lucentis®) was administered to the study eye by intravitreal injection every 4 weeks from Day 1 through Week 96.
|
|---|---|---|---|
|
Eye disorders
Eye pain
|
11.8%
37/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
11.1%
35/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
11.4%
36/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Conjunctival haemorrhage
|
7.7%
24/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
9.2%
29/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
9.2%
29/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Conjunctival hyperaemia
|
5.4%
17/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
4.8%
15/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
7.3%
23/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Neovascular age-related macular degeneration
|
5.8%
18/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
8.0%
25/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
6.7%
21/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Vitreous floaters
|
8.6%
27/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
9.6%
30/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
5.4%
17/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Vitreous detachment
|
5.1%
16/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
5.4%
17/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
3.5%
11/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Visual acuity reduced
|
5.4%
17/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
4.8%
15/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
1.9%
6/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Nasopharyngitis
|
10.5%
33/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
11.1%
35/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
12.7%
40/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Influenza
|
6.1%
19/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
4.8%
15/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
7.0%
22/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Urinary tract infection
|
7.0%
22/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
6.7%
21/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
3.8%
12/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Injury, poisoning and procedural complications
Fall
|
4.2%
13/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
4.5%
14/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
7.0%
22/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Investigations
Intraocular pressure increased
|
9.3%
29/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
9.2%
29/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
6.3%
20/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Nervous system disorders
Headache
|
3.5%
11/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
5.7%
18/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
5.4%
17/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
|
Vascular disorders
Hypertension
|
5.8%
18/313 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
7.0%
22/314 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
5.1%
16/315 • From the first dose up to last dose (Up to Week 104)
Safety population included all treated participants.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER