Trial Outcomes & Findings for OPT-302 With Ranibizumab in Neovascular Age-related Macular Degeneration (nAMD) (NCT NCT04757610)
NCT ID: NCT04757610
Last Updated: 2025-07-22
Results Overview
To determine the efficacy of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 0.5 mg ranibizumab, in participants with neovascular age-related macular degeneration (nAMD), in terms of change in ETDRS BCVA letter score in the study eye from Baseline to Week 52. The primary analysis presented used mixed model for repeated measures in the overall population. (A positive outcome measure means an improvement in ETDRS BCVA letter score from baseline; a negative outcome measure means a deterioration in ETDRS BCVA letter score from baseline)
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
986 participants
Primary outcome timeframe
Baseline to Week 52
Results posted on
2025-07-22
Participant Flow
Participants 50 years or older with active subfoveal CNV lesion or juxtafoveal CNV lesion with foveal involvement that is secondary to AMD in the study eye with an ETDRS BCVA score between 60 and 25 (inclusive) letters in the study eye.
Participants who met all inclusion criteria and none of the exclusion criteria were enrolled in the study. 1 subject (in the 0.5 mg ranibizumab with standard dosing 2.0 mg OPT-302 arm) was enrolled, but never treated.
Participant milestones
| Measure |
0.5 mg Ranibizumab With Standard Dosing 2.0 mg OPT-302
0.5 mg ranibizumab intravitreal injection (0.05mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05mL) administered into the study eye at 4-weekly intervals through Week 96.
2.0 mg OPT-302: intravitreal injection
0.5 mg ranibizumab: intravitreal injection
|
0.5 mg Ranibizumab With Extended Dosing 2.0 mg OPT-302
0.5 mg ranibizumab intravitreal injection (0.05mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05mL) administered into the study eye at 4-weekly intervals for three treatments, and then at 8-weekly intervals through Week 96, with ranibizumab intravitreal injection followed by sham intravitreal injection administered into the study eye at the alternating visits when OPT-302 was not administered.
2.0 mg OPT-302: intravitreal injection
0.5 mg ranibizumab: intravitreal injection
Sham: intravitreal injection
|
0.5 mg Ranibizumab With Sham
0.5 mg ranibizumab intravitreal injection (0.05mL) followed by sham intravitreal injection administered into the study eye at 4-weekly intervals through Week 96.
0.5 mg ranibizumab: intravitreal injection
Sham: intravitreal injection
|
|---|---|---|---|
|
Overall Study
STARTED
|
329
|
326
|
331
|
|
Overall Study
Treated
|
328
|
326
|
331
|
|
Overall Study
COMPLETED
|
167
|
168
|
171
|
|
Overall Study
NOT COMPLETED
|
162
|
158
|
160
|
Reasons for withdrawal
| Measure |
0.5 mg Ranibizumab With Standard Dosing 2.0 mg OPT-302
0.5 mg ranibizumab intravitreal injection (0.05mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05mL) administered into the study eye at 4-weekly intervals through Week 96.
2.0 mg OPT-302: intravitreal injection
0.5 mg ranibizumab: intravitreal injection
|
0.5 mg Ranibizumab With Extended Dosing 2.0 mg OPT-302
0.5 mg ranibizumab intravitreal injection (0.05mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05mL) administered into the study eye at 4-weekly intervals for three treatments, and then at 8-weekly intervals through Week 96, with ranibizumab intravitreal injection followed by sham intravitreal injection administered into the study eye at the alternating visits when OPT-302 was not administered.
2.0 mg OPT-302: intravitreal injection
0.5 mg ranibizumab: intravitreal injection
Sham: intravitreal injection
|
0.5 mg Ranibizumab With Sham
0.5 mg ranibizumab intravitreal injection (0.05mL) followed by sham intravitreal injection administered into the study eye at 4-weekly intervals through Week 96.
0.5 mg ranibizumab: intravitreal injection
Sham: intravitreal injection
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
13
|
10
|
5
|
|
Overall Study
Death
|
5
|
13
|
8
|
|
Overall Study
Lack of Efficacy
|
1
|
2
|
3
|
|
Overall Study
Lost to Follow-up
|
7
|
2
|
7
|
|
Overall Study
Physician Decision
|
4
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
26
|
25
|
25
|
|
Overall Study
Study Terminated by Sponsor
|
105
|
105
|
110
|
|
Overall Study
Randomized in Error
|
1
|
0
|
0
|
Baseline Characteristics
OPT-302 With Ranibizumab in Neovascular Age-related Macular Degeneration (nAMD)
Baseline characteristics by cohort
| Measure |
0.5 mg Ranibizumab With Standard Dosing 2.0 mg OPT-302
n=328 Participants
0.5 mg ranibizumab intravitreal injection (0.05mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05mL) administered into the study eye at 4-weekly intervals through Week 96.
2.0 mg OPT-302: intravitreal injection
0.5 mg ranibizumab: intravitreal injection
|
0.5 mg Ranibizumab With Extended Dosing 2.0 mg OPT-302
n=326 Participants
0.5 mg ranibizumab intravitreal injection (0.05mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05mL) administered into the study eye at 4-weekly intervals for three treatments, and then at 8-weekly intervals through Week 96, with ranibizumab intravitreal injection followed by sham intravitreal injection administered into the study eye at the alternating visits when OPT-302 was not administered.
2.0 mg OPT-302: intravitreal injection
0.5 mg ranibizumab: intravitreal injection
Sham: intravitreal injection
|
0.5 mg Ranibizumab With Sham
n=331 Participants
0.5 mg ranibizumab intravitreal injection (0.05mL) followed by sham intravitreal injection administered into the study eye at 4-weekly intervals through Week 96.
0.5 mg ranibizumab: intravitreal injection
Sham: intravitreal injection
|
Total
n=985 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
104 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
297 Participants
n=5 Participants
|
288 Participants
n=7 Participants
|
296 Participants
n=5 Participants
|
881 Participants
n=4 Participants
|
|
Age, Continuous
|
75.3 years
STANDARD_DEVIATION 8.28 • n=5 Participants
|
75.8 years
STANDARD_DEVIATION 8.62 • n=7 Participants
|
75.1 years
STANDARD_DEVIATION 8.52 • n=5 Participants
|
75.4 years
STANDARD_DEVIATION 8.47 • n=4 Participants
|
|
Sex: Female, Male
Female
|
184 Participants
n=5 Participants
|
169 Participants
n=7 Participants
|
179 Participants
n=5 Participants
|
532 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
144 Participants
n=5 Participants
|
157 Participants
n=7 Participants
|
152 Participants
n=5 Participants
|
453 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
117 Participants
n=5 Participants
|
121 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
361 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
201 Participants
n=5 Participants
|
195 Participants
n=7 Participants
|
203 Participants
n=5 Participants
|
599 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
44 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
134 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
277 Participants
n=5 Participants
|
273 Participants
n=7 Participants
|
274 Participants
n=5 Participants
|
824 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Early Treatment Retinopathy Study (ETDRS) Best-Corrected Visual Acuity (BCVA) Letters
|
52.1 letters read
STANDARD_DEVIATION 9.45 • n=5 Participants
|
52.1 letters read
STANDARD_DEVIATION 8.83 • n=7 Participants
|
52.5 letters read
STANDARD_DEVIATION 9.13 • n=5 Participants
|
52.23 letters read
STANDARD_DEVIATION 9.14 • n=4 Participants
|
|
Choroidal Neovascularisation (CNV) Area by Fluorescein Angiography (FA)
|
6.256 mm^2
STANDARD_DEVIATION 2.8634 • n=5 Participants
|
6.576 mm^2
STANDARD_DEVIATION 3.2278 • n=7 Participants
|
6.286 mm^2
STANDARD_DEVIATION 3.1770 • n=5 Participants
|
6.373 mm^2
STANDARD_DEVIATION 3.0894 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 52Population: Modified Intent-to-Treat (mITT) analysis set - comprised all randomised participants with at least one dose of study medication. Participants were analysed according to the study medication to which they were randomised for all efficacy analyses.
To determine the efficacy of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 0.5 mg ranibizumab, in participants with neovascular age-related macular degeneration (nAMD), in terms of change in ETDRS BCVA letter score in the study eye from Baseline to Week 52. The primary analysis presented used mixed model for repeated measures in the overall population. (A positive outcome measure means an improvement in ETDRS BCVA letter score from baseline; a negative outcome measure means a deterioration in ETDRS BCVA letter score from baseline)
Outcome measures
| Measure |
0.5 mg Ranibizumab With Standard Dosing 2.0 mg OPT-302
n=328 Participants
0.5 mg ranibizumab intravitreal injection (0.05mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05mL) administered into the study eye at 4-weekly intervals through Week 96.
2.0 mg OPT-302: intravitreal injection
0.5 mg ranibizumab: intravitreal injection
|
0.5 mg Ranibizumab With Extended Dosing 2.0 mg OPT-302
n=326 Participants
0.5 mg ranibizumab intravitreal injection (0.05mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05mL) administered into the study eye at 4-weekly intervals for three treatments, and then at 8-weekly intervals through Week 96, with ranibizumab intravitreal injection followed by sham intravitreal injection administered into the study eye at the alternating visits when OPT-302 was not administered.
2.0 mg OPT-302: intravitreal injection
0.5 mg ranibizumab: intravitreal injection
Sham: intravitreal injection
|
0.5 mg Ranibizumab With Sham
n=331 Participants
0.5 mg ranibizumab intravitreal injection (0.05mL) followed by sham intravitreal injection administered into the study eye at 4-weekly intervals through Week 96.
0.5 mg ranibizumab: intravitreal injection
Sham: intravitreal injection
|
|---|---|---|---|
|
Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) Letters
|
13.20 Letters read
Standard Error 0.728
|
12.41 Letters read
Standard Error 0.731
|
14.30 Letters read
Standard Error 0.719
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: Modified Intent-to-Treat (mITT) analysis set - comprised all randomised participants with at least one dose of study medication. Participants were analysed according to the study medication to which they were randomised for all efficacy analyses.
To determine the effects of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 0.5 mg ranibizumab, in participants with neovascular age-related macular degeneration (nAMD), in terms of proportion of participants gaining 15 or more letters in ETDRS BCVA in the study eye from Baseline to Week 52.
Outcome measures
| Measure |
0.5 mg Ranibizumab With Standard Dosing 2.0 mg OPT-302
n=292 Participants
0.5 mg ranibizumab intravitreal injection (0.05mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05mL) administered into the study eye at 4-weekly intervals through Week 96.
2.0 mg OPT-302: intravitreal injection
0.5 mg ranibizumab: intravitreal injection
|
0.5 mg Ranibizumab With Extended Dosing 2.0 mg OPT-302
n=290 Participants
0.5 mg ranibizumab intravitreal injection (0.05mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05mL) administered into the study eye at 4-weekly intervals for three treatments, and then at 8-weekly intervals through Week 96, with ranibizumab intravitreal injection followed by sham intravitreal injection administered into the study eye at the alternating visits when OPT-302 was not administered.
2.0 mg OPT-302: intravitreal injection
0.5 mg ranibizumab: intravitreal injection
Sham: intravitreal injection
|
0.5 mg Ranibizumab With Sham
n=297 Participants
0.5 mg ranibizumab intravitreal injection (0.05mL) followed by sham intravitreal injection administered into the study eye at 4-weekly intervals through Week 96.
0.5 mg ranibizumab: intravitreal injection
Sham: intravitreal injection
|
|---|---|---|---|
|
Participants Gaining 15 or More ETDRS BCVA Letters
|
159 Participants
|
135 Participants
|
164 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: Modified Intent-to-Treat (mITT) analysis set - comprised all randomised participants with at least one dose of study medication. Participants were analysed according to the study medication to which they were randomised for all efficacy analyses.
To determine the effects of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 0.5 mg ranibizumab, in participants with neovascular age-related macular degeneration (nAMD), in terms of proportion of participants gaining 10 or more letters in ETDRS BCVA in the study eye from Baseline to Week 52.
Outcome measures
| Measure |
0.5 mg Ranibizumab With Standard Dosing 2.0 mg OPT-302
n=292 Participants
0.5 mg ranibizumab intravitreal injection (0.05mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05mL) administered into the study eye at 4-weekly intervals through Week 96.
2.0 mg OPT-302: intravitreal injection
0.5 mg ranibizumab: intravitreal injection
|
0.5 mg Ranibizumab With Extended Dosing 2.0 mg OPT-302
n=290 Participants
0.5 mg ranibizumab intravitreal injection (0.05mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05mL) administered into the study eye at 4-weekly intervals for three treatments, and then at 8-weekly intervals through Week 96, with ranibizumab intravitreal injection followed by sham intravitreal injection administered into the study eye at the alternating visits when OPT-302 was not administered.
2.0 mg OPT-302: intravitreal injection
0.5 mg ranibizumab: intravitreal injection
Sham: intravitreal injection
|
0.5 mg Ranibizumab With Sham
n=297 Participants
0.5 mg ranibizumab intravitreal injection (0.05mL) followed by sham intravitreal injection administered into the study eye at 4-weekly intervals through Week 96.
0.5 mg ranibizumab: intravitreal injection
Sham: intravitreal injection
|
|---|---|---|---|
|
Participants Gaining 10 More ETDRS BCVA Letters
|
198 Participants
|
182 Participants
|
202 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: Modified Intent-to-Treat (mITT) analysis set - comprised all randomised participants with at least one dose of study medication. Participants were analysed according to the study medication to which they were randomised for all efficacy analyses.
To determine the effects of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 0.5 mg ranibizumab, in participants with neovascular age-related macular degeneration (nAMD), in terms of change in CNV area as measured by FA in the study eye from Baseline to Week 52.
Outcome measures
| Measure |
0.5 mg Ranibizumab With Standard Dosing 2.0 mg OPT-302
n=147 Participants
0.5 mg ranibizumab intravitreal injection (0.05mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05mL) administered into the study eye at 4-weekly intervals through Week 96.
2.0 mg OPT-302: intravitreal injection
0.5 mg ranibizumab: intravitreal injection
|
0.5 mg Ranibizumab With Extended Dosing 2.0 mg OPT-302
n=132 Participants
0.5 mg ranibizumab intravitreal injection (0.05mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05mL) administered into the study eye at 4-weekly intervals for three treatments, and then at 8-weekly intervals through Week 96, with ranibizumab intravitreal injection followed by sham intravitreal injection administered into the study eye at the alternating visits when OPT-302 was not administered.
2.0 mg OPT-302: intravitreal injection
0.5 mg ranibizumab: intravitreal injection
Sham: intravitreal injection
|
0.5 mg Ranibizumab With Sham
n=154 Participants
0.5 mg ranibizumab intravitreal injection (0.05mL) followed by sham intravitreal injection administered into the study eye at 4-weekly intervals through Week 96.
0.5 mg ranibizumab: intravitreal injection
Sham: intravitreal injection
|
|---|---|---|---|
|
Change in Choroidal Neovascularisation (CNV) Area by Fluorescein Angiography (FA)
|
-3.359 mm^2
Standard Error 0.3483
|
-3.901 mm^2
Standard Error 0.3972
|
-3.238 mm^2
Standard Error 0.3588
|
SECONDARY outcome
Timeframe: at Week 52Population: Modified Intent-to-Treat (mITT) analysis set - comprised all randomised participants with at least one dose of study medication. Participants were analysed according to the study medication to which they were randomised for all efficacy analyses.
To determine the effects of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 0.5 mg ranibizumab, in participants with neovascular age-related macular degeneration (nAMD), in terms of proportion of participants with absence of both sub-retinal fluid and intra-retinal cysts by SD-OCT in the study eye at Week 52.
Outcome measures
| Measure |
0.5 mg Ranibizumab With Standard Dosing 2.0 mg OPT-302
n=260 Participants
0.5 mg ranibizumab intravitreal injection (0.05mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05mL) administered into the study eye at 4-weekly intervals through Week 96.
2.0 mg OPT-302: intravitreal injection
0.5 mg ranibizumab: intravitreal injection
|
0.5 mg Ranibizumab With Extended Dosing 2.0 mg OPT-302
n=258 Participants
0.5 mg ranibizumab intravitreal injection (0.05mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05mL) administered into the study eye at 4-weekly intervals for three treatments, and then at 8-weekly intervals through Week 96, with ranibizumab intravitreal injection followed by sham intravitreal injection administered into the study eye at the alternating visits when OPT-302 was not administered.
2.0 mg OPT-302: intravitreal injection
0.5 mg ranibizumab: intravitreal injection
Sham: intravitreal injection
|
0.5 mg Ranibizumab With Sham
n=265 Participants
0.5 mg ranibizumab intravitreal injection (0.05mL) followed by sham intravitreal injection administered into the study eye at 4-weekly intervals through Week 96.
0.5 mg ranibizumab: intravitreal injection
Sham: intravitreal injection
|
|---|---|---|---|
|
Participants With Absence of Both Sub-retinal Fluid and Intra-retinal Cysts by SD-OCT
|
33 Participants
|
22 Participants
|
22 Participants
|
Adverse Events
0.5 mg Ranibizumab With Standard Dosing 2.0 mg OPT-302
Serious events: 65 serious events
Other events: 290 other events
Deaths: 5 deaths
0.5 mg Ranibizumab With Extended Dosing 2.0 mg OPT-302
Serious events: 60 serious events
Other events: 261 other events
Deaths: 13 deaths
0.5 mg Ranibizumab With Sham
Serious events: 52 serious events
Other events: 265 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
0.5 mg Ranibizumab With Standard Dosing 2.0 mg OPT-302
n=328 participants at risk
0.5 mg ranibizumab intravitreal injection (0.05mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05mL) administered into the study eye at 4-weekly intervals through Week 96.
2.0 mg OPT-302: intravitreal injection
0.5 mg ranibizumab: intravitreal injection
|
0.5 mg Ranibizumab With Extended Dosing 2.0 mg OPT-302
n=327 participants at risk
0.5 mg ranibizumab intravitreal injection (0.05mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05mL) administered into the study eye at 4-weekly intervals for three treatments, and then at 8-weekly intervals through Week 96, with ranibizumab intravitreal injection followed by sham intravitreal injection administered into the study eye at the alternating visits when OPT-302 was not administered.
2.0 mg OPT-302: intravitreal injection
0.5 mg ranibizumab: intravitreal injection
Sham: intravitreal injection
|
0.5 mg Ranibizumab With Sham
n=330 participants at risk
0.5 mg ranibizumab intravitreal injection (0.05mL) followed by sham intravitreal injection administered into the study eye at 4-weekly intervals through Week 96.
0.5 mg ranibizumab: intravitreal injection
Sham: intravitreal injection
|
|---|---|---|---|
|
Eye disorders
Cataract
|
0.91%
3/328 • Number of events 3 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Eye disorders
Angle closure glaucoma
|
0.30%
1/328 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.31%
1/327 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Eye disorders
Retinal detachment
|
0.30%
1/328 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.30%
1/330 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Eye disorders
Rhegmatogenous retinal detachment
|
0.30%
1/328 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.30%
1/330 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Eye disorders
Retinal artery embolism
|
0.30%
1/328 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Eye disorders
Retinal haemorrhage
|
0.30%
1/328 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Eye disorders
Vitreous haemorrhage
|
0.30%
1/328 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Eye disorders
Vitritis
|
0.30%
1/328 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Eye disorders
Retinal pigment epithelial tear
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.31%
1/327 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.30%
1/330 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Eye disorders
Eye inflammation
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.31%
1/327 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Eye disorders
Optic neuropathy
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.31%
1/327 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Eye disorders
Retinal tear
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.31%
1/327 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.31%
1/327 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Infections and infestations
Endophthalmitis
|
1.2%
4/328 • Number of events 4 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.31%
1/327 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.30%
1/330 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Eye disorders
Glaucoma
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.30%
1/330 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.30%
1/328 • Number of events 2 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.30%
1/330 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.91%
3/328 • Number of events 3 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.61%
2/327 • Number of events 3 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.61%
2/330 • Number of events 2 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.61%
2/328 • Number of events 2 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.92%
3/327 • Number of events 4 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.30%
1/330 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Cardiac disorders
Coronary artery disease
|
0.61%
2/328 • Number of events 2 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.30%
1/328 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.31%
1/327 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.30%
1/328 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.30%
1/328 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
1.8%
6/327 • Number of events 7 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.61%
2/330 • Number of events 2 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.61%
2/327 • Number of events 2 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.30%
1/330 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.31%
1/327 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.31%
1/327 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Cardiac disorders
Hypertensive heart disease
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.31%
1/327 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.30%
1/330 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.30%
1/330 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.30%
1/330 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.30%
1/330 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.30%
1/330 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.31%
1/327 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Gastrointestinal disorders
Colitis
|
0.30%
1/328 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.30%
1/328 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.30%
1/328 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.31%
1/327 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.30%
1/330 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.31%
1/327 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.30%
1/330 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Gastrointestinal disorders
Abdominal compartment syndrome
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.31%
1/327 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Gastrointestinal disorders
Enterocele
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.31%
1/327 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.31%
1/327 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.31%
1/327 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.31%
1/327 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.31%
1/327 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.31%
1/327 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Gastrointestinal disorders
Pancreatic mass
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.31%
1/327 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.30%
1/330 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Gastrointestinal disorders
Mesenteric arterial occlusion
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.30%
1/330 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.30%
1/330 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
General disorders
Death
|
0.30%
1/328 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.31%
1/327 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.30%
1/330 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
General disorders
Asthenia
|
0.30%
1/328 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.31%
1/327 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
General disorders
Pyrexia
|
0.30%
1/328 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.30%
1/328 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
General disorders
General physical health deterioration
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.31%
1/327 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
General disorders
Gait disturbance
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.30%
1/330 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.61%
2/328 • Number of events 2 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.30%
1/328 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.31%
1/327 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.30%
1/330 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.30%
1/328 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Hepatobiliary disorders
Cholelithiasis obstructive
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.30%
1/330 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.30%
1/330 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Infections and infestations
Pneumonia
|
0.61%
2/328 • Number of events 2 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.92%
3/327 • Number of events 3 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.61%
2/330 • Number of events 2 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Infections and infestations
COVID-19
|
0.61%
2/328 • Number of events 2 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.31%
1/327 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Infections and infestations
COVID-19 Pneumonia
|
0.61%
2/328 • Number of events 2 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.31%
1/327 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Infections and infestations
Cellulitis
|
0.30%
1/328 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.61%
2/327 • Number of events 2 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.61%
2/330 • Number of events 2 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.30%
1/328 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Infections and infestations
Respiratory tract infection
|
0.30%
1/328 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Infections and infestations
Septic shock
|
0.30%
1/328 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.31%
1/327 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.30%
1/330 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.31%
1/327 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.30%
1/330 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.31%
1/327 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.31%
1/327 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Infections and infestations
Klebsiella urinary tract infection
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.31%
1/327 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Infections and infestations
Sepsis
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.31%
1/327 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.31%
1/327 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Infections and infestations
Medical device site infection
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.30%
1/330 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Infections and infestations
Skin bacterial infection
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.30%
1/330 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
1.2%
4/328 • Number of events 4 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.31%
1/327 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Injury, poisoning and procedural complications
Fall
|
0.61%
2/328 • Number of events 2 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.92%
3/327 • Number of events 3 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.61%
2/330 • Number of events 2 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.61%
2/328 • Number of events 2 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.30%
1/330 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Injury, poisoning and procedural complications
Craniofacial fracture
|
0.30%
1/328 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.30%
1/330 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.30%
1/328 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.30%
1/328 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.30%
1/328 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.30%
1/328 • Number of events 2 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Injury, poisoning and procedural complications
Femure fracture
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.31%
1/327 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.30%
1/330 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.31%
1/327 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.31%
1/327 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.30%
1/330 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Injury, poisoning and procedural complications
Carotid artery restenosis
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.30%
1/330 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.30%
1/330 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.30%
1/328 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.31%
1/327 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Metabolism and nutrition disorders
Hyperammonaemia
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.30%
1/330 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.30%
1/330 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.30%
1/330 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Metabolism and nutrition disorders
Type I diabetes mellitus
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.30%
1/330 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.61%
2/328 • Number of events 2 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.31%
1/327 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.31%
1/327 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.31%
1/327 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.30%
1/330 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic carcinoma of the bladder
|
0.61%
2/328 • Number of events 2 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.30%
1/328 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neoplasm
|
0.30%
1/328 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.30%
1/328 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.31%
1/327 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.30%
1/330 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.31%
1/327 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.31%
1/327 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Marginal zone lymphoma
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.31%
1/327 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.31%
1/327 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.30%
1/330 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer metastatic
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.30%
1/330 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer stage III
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.30%
1/330 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cutaneous T-cell lymphoma
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.30%
1/330 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.30%
1/330 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer metastatic
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.30%
1/330 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.30%
1/330 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.30%
1/330 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.30%
1/330 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Nervous system disorders
Ischaemic stroke
|
0.61%
2/328 • Number of events 2 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.61%
2/327 • Number of events 2 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.91%
3/330 • Number of events 3 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.61%
2/328 • Number of events 2 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.31%
1/327 • Number of events 2 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Nervous system disorders
Ataxia
|
0.30%
1/328 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Nervous system disorders
Radiculopathy
|
0.30%
1/328 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Nervous system disorders
Cerebral thrombosis
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.30%
1/330 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.30%
1/330 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.30%
1/330 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.30%
1/330 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Nervous system disorders
Neurodegenerative disorder
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.30%
1/330 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Psychiatric disorders
Rapid eye movement sleep behaviour disorder
|
0.30%
1/328 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.30%
1/328 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.61%
2/327 • Number of events 2 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Renal and urinary disorders
Haematuria
|
0.30%
1/328 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.30%
1/330 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.61%
2/328 • Number of events 2 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.61%
2/327 • Number of events 2 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.61%
2/328 • Number of events 2 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.31%
1/327 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.30%
1/328 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.31%
1/327 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.30%
1/328 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.30%
1/330 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.30%
1/328 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.30%
1/328 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis aspiration
|
0.30%
1/328 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.31%
1/327 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary amyloidosis
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.31%
1/327 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.31%
1/327 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.30%
1/330 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Vascular disorders
Deep vein thrombosis
|
0.30%
1/328 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.31%
1/327 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Vascular disorders
Haematoma
|
0.30%
1/328 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.31%
1/327 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.31%
1/327 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/330 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Vascular disorders
Hypertensive urgency
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.30%
1/330 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Vascular disorders
Peripheral venous disease
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.30%
1/330 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Vascular disorders
Venous hypertension
|
0.00%
0/328 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.00%
0/327 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
0.30%
1/330 • Number of events 1 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
Other adverse events
| Measure |
0.5 mg Ranibizumab With Standard Dosing 2.0 mg OPT-302
n=328 participants at risk
0.5 mg ranibizumab intravitreal injection (0.05mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05mL) administered into the study eye at 4-weekly intervals through Week 96.
2.0 mg OPT-302: intravitreal injection
0.5 mg ranibizumab: intravitreal injection
|
0.5 mg Ranibizumab With Extended Dosing 2.0 mg OPT-302
n=327 participants at risk
0.5 mg ranibizumab intravitreal injection (0.05mL) followed by 2.0 mg OPT-302 intravitreal injection (0.05mL) administered into the study eye at 4-weekly intervals for three treatments, and then at 8-weekly intervals through Week 96, with ranibizumab intravitreal injection followed by sham intravitreal injection administered into the study eye at the alternating visits when OPT-302 was not administered.
2.0 mg OPT-302: intravitreal injection
0.5 mg ranibizumab: intravitreal injection
Sham: intravitreal injection
|
0.5 mg Ranibizumab With Sham
n=330 participants at risk
0.5 mg ranibizumab intravitreal injection (0.05mL) followed by sham intravitreal injection administered into the study eye at 4-weekly intervals through Week 96.
0.5 mg ranibizumab: intravitreal injection
Sham: intravitreal injection
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
17.4%
57/328 • Number of events 79 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
12.8%
42/327 • Number of events 64 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
11.8%
39/330 • Number of events 53 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Eye disorders
Cataract
|
11.9%
39/328 • Number of events 42 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
10.1%
33/327 • Number of events 35 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
4.2%
14/330 • Number of events 14 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Eye disorders
Conjunctival haemorrhage
|
9.8%
32/328 • Number of events 49 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
12.8%
42/327 • Number of events 61 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
7.3%
24/330 • Number of events 39 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Eye disorders
Eye pain
|
9.8%
32/328 • Number of events 70 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
5.8%
19/327 • Number of events 38 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
6.1%
20/330 • Number of events 29 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Eye disorders
Vitreous floaters
|
7.0%
23/328 • Number of events 25 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
6.4%
21/327 • Number of events 22 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
4.2%
14/330 • Number of events 15 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Eye disorders
Vitreous detachment
|
6.1%
20/328 • Number of events 20 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
4.9%
16/327 • Number of events 16 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
3.9%
13/330 • Number of events 13 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Investigations
Intraocular pressure increased
|
10.7%
35/328 • Number of events 93 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
8.9%
29/327 • Number of events 71 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
4.8%
16/330 • Number of events 34 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Eye disorders
Neovascular age-related macular degeneration
|
6.7%
22/328 • Number of events 24 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
5.8%
19/327 • Number of events 20 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
8.2%
27/330 • Number of events 29 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Infections and infestations
COVID-19
|
9.8%
32/328 • Number of events 32 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
8.3%
27/327 • Number of events 28 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
11.5%
38/330 • Number of events 39 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Infections and infestations
Urinary tract infection
|
6.7%
22/328 • Number of events 25 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
7.0%
23/327 • Number of events 30 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
6.1%
20/330 • Number of events 27 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Infections and infestations
Influenza
|
5.8%
19/328 • Number of events 22 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
3.7%
12/327 • Number of events 13 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
3.3%
11/330 • Number of events 11 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.8%
19/328 • Number of events 25 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
3.4%
11/327 • Number of events 16 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
4.2%
14/330 • Number of events 18 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.6%
15/328 • Number of events 26 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
7.0%
23/327 • Number of events 37 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
4.8%
16/330 • Number of events 22 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.3%
14/328 • Number of events 15 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
4.6%
15/327 • Number of events 18 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
6.4%
21/330 • Number of events 25 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Nervous system disorders
Headache
|
6.4%
21/328 • Number of events 44 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
6.7%
22/327 • Number of events 32 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
7.6%
25/330 • Number of events 38 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
|
Vascular disorders
Hypertension
|
5.8%
19/328 • Number of events 20 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
6.4%
21/327 • Number of events 25 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
8.2%
27/330 • Number of events 31 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The principles for publication of results of this study will be addressed in clinical trial agreements between Opthea (Sponsor) and the study site, and Opthea and the subcontractors performing the study. Results means any and all information and know-how (whether patentable or not) which is discovered, invented or developed or which arises in the course of or as a result of the conduct of the Study, including any and all improvements to the products being studied.
- Publication restrictions are in place
Restriction type: OTHER