Trial Outcomes & Findings for A Safety and Efficacy Study of Abicipar Pegol in Participants With Neovascular Age-related Macular Degeneration (NCT NCT02462928)
NCT ID: NCT02462928
Last Updated: 2020-07-28
Results Overview
Stable vision was defined as a loss of fewer than 15 letters in BCVA compared to baseline. BCVA was measured using an eye chart and 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 loss of fewer than 15 letters are reported. The study eye is defined as the eye that meets the entry criteria. If both eyes met the entry criteria, the eye with the worse BCVA at baseline (Day 1) was selected as the study eye. If both eyes had same BCVA values at baseline (Day 1), then the participant had to select their non-dominant eye for treatment, or else the right eye was selected as the study eye.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
939 participants
Primary outcome timeframe
Baseline to Week 52
Results posted on
2020-07-28
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, Week 8 and every 8 weeks (2Q8) thereafter 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, Week 12, and every 12 weeks (2Q12) thereafter 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 0.5 mg (rQ4)
Ranibizumab (Lucentis®) 0.5 mg was administered to the study eye by intravitreal injection every 4 weeks (rQ4) from Day 1 through Week 96.
|
|---|---|---|---|
|
Overall Study
STARTED
|
314
|
313
|
312
|
|
Overall Study
COMPLETED
|
224
|
221
|
255
|
|
Overall Study
NOT COMPLETED
|
90
|
92
|
57
|
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, Week 8 and every 8 weeks (2Q8) thereafter 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, Week 12, and every 12 weeks (2Q12) thereafter 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 0.5 mg (rQ4)
Ranibizumab (Lucentis®) 0.5 mg was administered to the study eye by intravitreal injection every 4 weeks (rQ4) from Day 1 through Week 96.
|
|---|---|---|---|
|
Overall Study
Screen Failure:Missed Exclusion Criteria
|
1
|
1
|
2
|
|
Overall Study
Adverse Event
|
47
|
51
|
25
|
|
Overall Study
Lack of Efficacy
|
3
|
8
|
3
|
|
Overall Study
Lost to Follow-up
|
4
|
4
|
1
|
|
Overall Study
Withdrawal by Patient
|
31
|
21
|
21
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
|
Overall Study
Reason not Specified
|
4
|
6
|
5
|
Baseline Characteristics
The 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=314 Participants
Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 8 and every 8 weeks (2Q8) thereafter 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=313 Participants
Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 12, and every 12 weeks (2Q12) thereafter 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 0.5 mg (rQ4)
n=312 Participants
Ranibizumab (Lucentis®) 0.5 mg was administered to the study eye by intravitreal injection every 4 weeks (rQ4) from Day 1 through Week 96.
|
Total
n=939 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
75.5 years
STANDARD_DEVIATION 8.4 • n=314 Participants
|
76.9 years
STANDARD_DEVIATION 8.0 • n=313 Participants
|
77.1 years
STANDARD_DEVIATION 8.4 • n=312 Participants
|
76.5 years
STANDARD_DEVIATION 8.3 • n=939 Participants
|
|
Sex: Female, Male
Female
|
162 Participants
n=314 Participants
|
183 Participants
n=313 Participants
|
169 Participants
n=312 Participants
|
514 Participants
n=939 Participants
|
|
Sex: Female, Male
Male
|
152 Participants
n=314 Participants
|
130 Participants
n=313 Participants
|
143 Participants
n=312 Participants
|
425 Participants
n=939 Participants
|
|
Race/Ethnicity, Customized
White
|
249 Participants
n=314 Participants
|
248 Participants
n=313 Participants
|
243 Participants
n=312 Participants
|
740 Participants
n=939 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 Participants
n=314 Participants
|
1 Participants
n=313 Participants
|
1 Participants
n=312 Participants
|
4 Participants
n=939 Participants
|
|
Race/Ethnicity, Customized
Asian
|
49 Participants
n=314 Participants
|
44 Participants
n=313 Participants
|
45 Participants
n=312 Participants
|
138 Participants
n=939 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
12 Participants
n=314 Participants
|
12 Participants
n=313 Participants
|
11 Participants
n=312 Participants
|
35 Participants
n=939 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
2 Participants
n=314 Participants
|
8 Participants
n=313 Participants
|
12 Participants
n=312 Participants
|
22 Participants
n=939 Participants
|
|
Best-corrected Visual Acuity (BCVA) Per Per-protocol Population
|
56.7 letters
STANDARD_DEVIATION 13.3 • n=265 Participants • The 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 13.1 • n=262 Participants • The 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.
|
56.5 letters
STANDARD_DEVIATION 12.6 • n=290 Participants • The 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.
|
56.5 letters
STANDARD_DEVIATION 13.0 • n=817 Participants • The 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 Per ITT Population
|
56.4 letters
STANDARD_DEVIATION 13.4 • n=313 Participants • Number analyzed is the number of participants with data available at Baseline.
|
56.5 letters
STANDARD_DEVIATION 12.9 • n=313 Participants • Number analyzed is the number of participants with data available at Baseline.
|
56.5 letters
STANDARD_DEVIATION 12.5 • n=312 Participants • Number analyzed is the number of participants with data available at Baseline.
|
56.5 letters
STANDARD_DEVIATION 12.9 • n=938 Participants • Number analyzed is the number of participants with data available at Baseline.
|
|
Central Retinal Thickness (CRT)
|
384.7 microns
STANDARD_DEVIATION 142.7 • n=313 Participants • Number analyzed is the number of participants with data available at Baseline.
|
378.4 microns
STANDARD_DEVIATION 119.1 • n=313 Participants • Number analyzed is the number of participants with data available at Baseline.
|
378.2 microns
STANDARD_DEVIATION 120.5 • n=312 Participants • Number analyzed is the number of participants with data available at Baseline.
|
380.4 microns
STANDARD_DEVIATION 127.8 • n=938 Participants • Number analyzed is the number of participants with data available at Baseline.
|
|
National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25)
|
78.7 score on a scale
n=313 Participants • Number analyzed is the number of participants with data available at Baseline.
|
77.3 score on a scale
n=313 Participants • Number analyzed is the number of participants with data available at Baseline.
|
77.1 score on a scale
n=311 Participants • Number analyzed is the number of participants with data available at Baseline.
|
77.7 score on a scale
n=937 Participants • Number analyzed is the number of participants with data available at Baseline.
|
PRIMARY outcome
Timeframe: Baseline to Week 52Population: The 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 a loss of fewer than 15 letters in BCVA compared to baseline. BCVA was measured using an eye chart and 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 loss of fewer than 15 letters are reported. The study eye is defined as the eye that meets the entry criteria. If both eyes met the entry criteria, the eye with the worse BCVA at baseline (Day 1) was selected as the study eye. If both eyes had same BCVA values at baseline (Day 1), then the participant had to select their non-dominant eye for treatment, or else the right eye was selected as the study eye.
Outcome measures
| Measure |
Abicipar Pegol 2 mg (2Q8)
n=265 Participants
Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 8 and every 8 weeks (2Q8) thereafter 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=262 Participants
Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 12, and every 12 weeks (2Q12) thereafter 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 0.5 mg (rQ4)
n=290 Participants
Ranibizumab (Lucentis®) 0.5 mg was administered to the study eye by intravitreal injection every 4 weeks (rQ4) from Day 1 through Week 96.
|
|---|---|---|---|
|
Percentage of Participants With Stable Vision at Week 52
|
91.7 percentage of participants
|
91.2 percentage of participants
|
95.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: The 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 was 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 study eye is defined as the eye that meets the entry criteria. If both eyes met the entry criteria, the eye with the worse BCVA at baseline (Day 1) was selected as the study eye. If both eyes had same BCVA values at baseline (Day 1), then the participant had to select their nondominant eye for treatment, or else the right eye was selected as the study eye. Mixed model for repeated measures (MMRM) analysis was used.
Outcome measures
| Measure |
Abicipar Pegol 2 mg (2Q8)
n=241 Participants
Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 8 and every 8 weeks (2Q8) thereafter 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=239 Participants
Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 12, and every 12 weeks (2Q12) thereafter 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 0.5 mg (rQ4)
n=272 Participants
Ranibizumab (Lucentis®) 0.5 mg was administered to the study eye by intravitreal injection every 4 weeks (rQ4) from Day 1 through Week 96.
|
|---|---|---|---|
|
Mean Change From Baseline in BCVA in the Study Eye at Week 52
|
6.7 letters
Standard Deviation 12.9
|
5.6 letters
Standard Deviation 13.3
|
8.5 letters
Standard Deviation 13.6
|
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.
CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement. The study eye is defined as the eye that meets the entry criteria. If both eyes met the entry criteria, the eye with the worse BCVA at baseline (Day 1) was selected as the study eye. If both eyes had same BCVA values at baseline (Day 1), then the participant had to select their non-dominant eye for treatment, or else the right eye was selected as the study eye. MMRM analysis was used.
Outcome measures
| Measure |
Abicipar Pegol 2 mg (2Q8)
n=242 Participants
Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 8 and every 8 weeks (2Q8) thereafter 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=235 Participants
Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 12, and every 12 weeks (2Q12) thereafter 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 0.5 mg (rQ4)
n=269 Participants
Ranibizumab (Lucentis®) 0.5 mg was administered to the study eye by intravitreal injection every 4 weeks (rQ4) from Day 1 through Week 96.
|
|---|---|---|---|
|
Mean Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye at Week 52
|
-141.5 microns
Standard Deviation 136.4
|
-150.1 microns
Standard Deviation 127.4
|
-141.3 microns
Standard Deviation 122.0
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: ITT population included all randomized participants.
BCVA was measured using an eye chart and 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 study eye is defined as the eye that meets the entry criteria. If both eyes met the entry criteria, the eye with the worse BCVA at baseline (Day 1) was selected as the study eye. If both eyes had same BCVA values at baseline (Day 1), then the participant had to select their non-dominant eye for treatment, or else the right eye was selected as the study eye.
Outcome measures
| Measure |
Abicipar Pegol 2 mg (2Q8)
n=314 Participants
Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 8 and every 8 weeks (2Q8) thereafter 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=313 Participants
Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 12, and every 12 weeks (2Q12) thereafter 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 0.5 mg (rQ4)
n=312 Participants
Ranibizumab (Lucentis®) 0.5 mg was administered to the study eye by intravitreal injection every 4 weeks (rQ4) from Day 1 through Week 96.
|
|---|---|---|---|
|
Percentage of Participants With a Gain of 15 or More ETDRS Letters in BCVA From Baseline in Study Eye at Week 52
|
22.6 percentage of participants
|
19.2 percentage of participants
|
27.2 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 related function. The overall composite score is then calculated by averaging over all 11 vision-targeted subscale scores, excluding the general health score. Overall composite score was calculated based on mean of non-missing subscales. Study eye was defined as 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=250 Participants
Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 8 and every 8 weeks (2Q8) thereafter 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=253 Participants
Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 12, and every 12 weeks (2Q12) thereafter 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 0.5 mg (rQ4)
n=273 Participants
Ranibizumab (Lucentis®) 0.5 mg was administered to the study eye by intravitreal injection every 4 weeks (rQ4) from Day 1 through Week 96.
|
|---|---|---|---|
|
Mean Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) Composite Score in Study Eye at Week 52
|
2.7 score on a scale
Standard Error 0.7
|
3.7 score on a scale
Standard Error 0.7
|
4.6 score on a scale
Standard Error 0.7
|
Adverse Events
Abicipar Pegol 2 mg (2Q8)
Serious events: 92 serious events
Other events: 202 other events
Deaths: 8 deaths
Abicipar Pegol 2 mg (2Q12)
Serious events: 102 serious events
Other events: 217 other events
Deaths: 7 deaths
Ranibizumab 0.5 mg (rQ4)
Serious events: 95 serious events
Other events: 196 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
Abicipar Pegol 2 mg (2Q8)
n=312 participants at risk
Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 8 and every 8 weeks (2Q8) thereafter 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=312 participants at risk
Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 12, and every 12 weeks (2Q12) thereafter 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 0.5 mg (rQ4)
n=310 participants at risk
Ranibizumab (Lucentis®) 0.5 mg was administered to the study eye by intravitreal injection every 4 weeks (rQ4) from Day 1 through Week 96.
|
|---|---|---|---|
|
Cardiac disorders
Hypertensive heart disease
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.64%
2/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Cardiac disorders
Left ventricular failure
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Cardiac disorders
Mitral valve prolapse
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.64%
2/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
1.3%
4/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Cardiac disorders
Atrial fibrillation
|
0.96%
3/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
1.3%
4/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
1.3%
4/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Cardiac disorders
Coronary artery disease
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.64%
2/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.97%
3/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.64%
2/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.96%
3/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.65%
2/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.96%
3/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.65%
2/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.65%
2/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Cardiac disorders
Cardiac failure
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.65%
2/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.65%
2/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Cardiac disorders
Myocardial infarction
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Cardiac disorders
Atrial flutter
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Cardiac disorders
Cardiac tamponade
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Retinal artery occlusion
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.96%
3/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Retinal haemorrhage
|
1.3%
4/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Neovascular age-related macular degeneration
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Retinal pigment epithelial tear
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Macular degeneration
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Uveitis
|
3.2%
10/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
3.2%
10/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Iridocyclitis
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
1.3%
4/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Retinal vasculitis
|
1.9%
6/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.96%
3/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Visual acuity reduced
|
1.3%
4/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.96%
3/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Vitritis
|
1.6%
5/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.64%
2/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Cataract
|
0.96%
3/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Autoimmune uveitis
|
0.64%
2/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Eye pain
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Macular fibrosis
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Ocular hypertension
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Age-related macular degeneration
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Iritis
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Macular scar
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Optic disc haemorrhage
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Optic ischaemic neuropathy
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Vitreous adhesions
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Retinal detachment
|
0.96%
3/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Dacryostenosis acquired
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Diplopia
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Glaucoma
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Lacrimation increased
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Necrotising retinitis
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Photopsia
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Retinal oedema
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Retinal tear
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Retinal vein occlusion
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Subretinal fibrosis
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Visual impairment
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.65%
2/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.65%
2/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Gastrointestinal disorders
Constipation
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Gastrointestinal disorders
Femoral hernia incarcerated
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Gastrointestinal disorders
Functional gastrointestinal disorder
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Gastrointestinal disorders
Intestinal infarction
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.64%
2/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Gastrointestinal disorders
Gastrointestinal polyp haemorrhage
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Gastrointestinal disorders
Barrett's oesophagus
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Gastrointestinal disorders
Haematemesis
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Gastrointestinal disorders
Incarcerated inguinal hernia
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Gastrointestinal disorders
Oesophageal spasm
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
General disorders
Non-cardiac chest pain
|
0.64%
2/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
General disorders
Death
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
General disorders
Pyrexia
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
General disorders
Asthenia
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
General disorders
Chest pain
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
General disorders
Fatigue
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
General disorders
Oedema peripheral
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.64%
2/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Hepatobiliary disorders
Hepatic mass
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Hepatobiliary disorders
Biliary dilatation
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Pneumonia
|
2.9%
9/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
2.9%
9/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
4.5%
14/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Endophthalmitis
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
1.3%
4/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.65%
2/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Sepsis
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.64%
2/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.65%
2/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Urinary tract infection
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.65%
2/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Bronchitis
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
1.6%
5/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Cellulitis
|
0.64%
2/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Device related infection
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Febrile infection
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Wound infection
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Diverticulitis
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Endocarditis
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Influenza
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Localised infection
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Periorbital cellulitis
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Septic shock
|
0.64%
2/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Abscess jaw
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Clostridium difficile infection
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Pulmonary sepsis
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Respiratory tract infection
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Retinitis
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Tracheobronchitis
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
1.6%
5/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.96%
3/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.97%
3/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.65%
2/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Injury, poisoning and procedural complications
Cataract operation complication
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.96%
3/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.64%
2/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.64%
2/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Injury, poisoning and procedural complications
Inflammation of wound
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Injury, poisoning and procedural complications
Periprosthetic fracture
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Injury, poisoning and procedural complications
Procedural pneumothorax
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Injury, poisoning and procedural complications
Ocular procedural complication
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Injury, poisoning and procedural complications
Procedural vomiting
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Injury, poisoning and procedural complications
Spinal column injury
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Investigations
Heart rate increased
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Investigations
Intraocular pressure increased
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Investigations
Blood pressure increased
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.96%
3/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.65%
2/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Metabolism and nutrition disorders
Adult failure to thrive
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.64%
2/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.97%
3/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.97%
3/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's contracture
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Musculoskeletal and connective tissue disorders
Ankle deformity
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Musculoskeletal and connective tissue disorders
Sacroiliitis
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.97%
3/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.65%
2/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.65%
2/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified stage IV
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.65%
2/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone sarcoma
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer female
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer stage IV
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal carcinoma
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.64%
2/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal stromal tumour
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (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%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer metastatic
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (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%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of skin
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone cancer
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Head and neck cancer metastatic
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to adrenals
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Spinal cord neoplasm
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Testis cancer
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil cancer
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.64%
2/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.64%
2/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
1.6%
5/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.64%
2/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Nervous system disorders
Quadrantanopia
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Nervous system disorders
Syncope
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Nervous system disorders
Dementia
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Nervous system disorders
Hypoaesthesia
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Nervous system disorders
Myelopathy
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Nervous system disorders
Optic neuritis
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Psychiatric disorders
Depression
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Psychiatric disorders
Suicide attempt
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Psychiatric disorders
Intensive care unit delirium
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Psychiatric disorders
Mental status changes
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Renal and urinary disorders
Nephritis
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Renal and urinary disorders
Bladder prolapse
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Renal and urinary disorders
Urinary retention
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.3%
4/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
1.6%
5/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.97%
3/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.65%
2/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.65%
2/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.64%
2/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.64%
2/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopneumopathy
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Skin and subcutaneous tissue disorders
Panniculitis
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Vascular disorders
Aortic aneurysm
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.64%
2/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.65%
2/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.64%
2/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Vascular disorders
Hypertension
|
0.64%
2/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Vascular disorders
Hypotension
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Vascular disorders
Haematoma
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.32%
1/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.00%
0/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
Other adverse events
| Measure |
Abicipar Pegol 2 mg (2Q8)
n=312 participants at risk
Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 8 and every 8 weeks (2Q8) thereafter 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=312 participants at risk
Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 12, and every 12 weeks (2Q12) thereafter 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 0.5 mg (rQ4)
n=310 participants at risk
Ranibizumab (Lucentis®) 0.5 mg was administered to the study eye by intravitreal injection every 4 weeks (rQ4) from Day 1 through Week 96.
|
|---|---|---|---|
|
Eye disorders
Conjunctival haemorrhage
|
8.7%
27/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
10.3%
32/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
14.8%
46/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Neovascular age-related macular degeneration
|
8.3%
26/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
9.0%
28/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
12.6%
39/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Eye pain
|
8.3%
26/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
8.3%
26/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
7.1%
22/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Cataract
|
9.3%
29/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
6.1%
19/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
6.5%
20/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Visual acuity reduced
|
7.7%
24/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
10.6%
33/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
5.8%
18/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Vitreous detachment
|
6.1%
19/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
6.7%
21/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
5.5%
17/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Retinal haemorrhage
|
5.1%
16/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
7.4%
23/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
5.2%
16/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Vitreous floaters
|
7.1%
22/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
6.4%
20/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
5.2%
16/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Eye irritation
|
3.5%
11/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
5.1%
16/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
2.9%
9/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Subretinal fluid
|
2.6%
8/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
5.4%
17/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
2.3%
7/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Eye disorders
Iridocyclitis
|
3.2%
10/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
5.8%
18/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
0.65%
2/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Nasopharyngitis
|
11.9%
37/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
11.5%
36/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
11.6%
36/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Urinary tract infection
|
6.1%
19/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
6.7%
21/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
10.0%
31/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Influenza
|
4.8%
15/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
5.1%
16/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
7.7%
24/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Bronchitis
|
7.4%
23/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
6.1%
19/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
7.4%
23/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Infections and infestations
Conjunctivitis
|
6.7%
21/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
6.4%
20/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
3.5%
11/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Injury, poisoning and procedural complications
Fall
|
3.5%
11/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
3.8%
12/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
5.5%
17/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Investigations
Intraocular pressure increased
|
4.8%
15/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
8.0%
25/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
4.2%
13/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.5%
14/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
6.7%
21/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
4.2%
13/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.5%
14/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
5.8%
18/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
3.2%
10/310 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
|
Vascular disorders
Hypertension
|
8.0%
25/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
6.4%
20/312 • From first dose to last dose of study drug (Up to Week 104)
Safety population included all treated participants.
|
9.0%
28/310 • From first dose to last dose of study drug (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