Trial Outcomes & Findings for OPT-302 With Aflibercept in Neovascular Age-related Macular Degeneration (nAMD) (NCT NCT04757636)
NCT ID: NCT04757636
Last Updated: 2025-08-05
Results Overview
To determine the efficacy of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 2.0 mg aflibercept, 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
998 participants
Primary outcome timeframe
Baseline to Week 52
Results posted on
2025-08-05
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. 2 subjects (in the 2.0 mg aflibercept with sham arm) were enrolled, but never treated.
Participant milestones
| Measure |
2.0 mg Aflibercept With Standard Dosing 2.0 mg OPT-302
2.0 mg aflibercept 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 OPT-302 administered alone at visits when aflibercept was not.
2.0 mg OPT-302: intravitreal injection
2.0 aflibercept: intravitreal injection
|
2.0 mg Aflibercept With Extended Dosing 2.0 mg OPT-302
2.0 mg aflibercept 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 sham intravitreal injection administered alone into the study eye at the alternating visits when aflibercept and OPT-302 were not administered.
2.0 mg OPT-302: intravitreal injection
2.0 aflibercept: intravitreal injection
Sham: intravitreal injection
|
2.0 mg Aflibercept With Sham
2.0 mg aflibercept intravitreal injection (0.05mL) followed by sham intravitreal injection administered into the study eye at 4-weekly intervals for three treatments, and then at 8-weekly intervals through Week 96, with sham intravitreal injection administered alone at visits when aflibercept was not.
2.0 aflibercept: intravitreal injection
Sham: intravitreal injection
|
|---|---|---|---|
|
Overall Study
STARTED
|
333
|
330
|
335
|
|
Overall Study
Treated
|
333
|
330
|
333
|
|
Overall Study
Completed Week 52 Visit
|
300
|
305
|
308
|
|
Overall Study
COMPLETED
|
172
|
173
|
172
|
|
Overall Study
NOT COMPLETED
|
161
|
157
|
163
|
Reasons for withdrawal
| Measure |
2.0 mg Aflibercept With Standard Dosing 2.0 mg OPT-302
2.0 mg aflibercept 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 OPT-302 administered alone at visits when aflibercept was not.
2.0 mg OPT-302: intravitreal injection
2.0 aflibercept: intravitreal injection
|
2.0 mg Aflibercept With Extended Dosing 2.0 mg OPT-302
2.0 mg aflibercept 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 sham intravitreal injection administered alone into the study eye at the alternating visits when aflibercept and OPT-302 were not administered.
2.0 mg OPT-302: intravitreal injection
2.0 aflibercept: intravitreal injection
Sham: intravitreal injection
|
2.0 mg Aflibercept With Sham
2.0 mg aflibercept intravitreal injection (0.05mL) followed by sham intravitreal injection administered into the study eye at 4-weekly intervals for three treatments, and then at 8-weekly intervals through Week 96, with sham intravitreal injection administered alone at visits when aflibercept was not.
2.0 aflibercept: intravitreal injection
Sham: intravitreal injection
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
25
|
8
|
11
|
|
Overall Study
Death
|
9
|
12
|
6
|
|
Overall Study
Lack of Efficacy
|
2
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
6
|
7
|
|
Overall Study
Physician Decision
|
1
|
3
|
4
|
|
Overall Study
Withdrawal by Subject
|
20
|
23
|
18
|
|
Overall Study
Discontinued Study Treatment at or prior to Week 52
|
0
|
1
|
0
|
|
Overall Study
Study Terminated by Sponsor
|
103
|
104
|
114
|
|
Overall Study
Sponsor Decision
|
0
|
0
|
1
|
|
Overall Study
Randomized in Error
|
0
|
0
|
2
|
Baseline Characteristics
OPT-302 With Aflibercept in Neovascular Age-related Macular Degeneration (nAMD)
Baseline characteristics by cohort
| Measure |
2.0 mg Aflibercept With Standard Dosing 2.0 mg OPT-302
n=333 Participants
2.0 mg aflibercept 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 OPT-302 administered alone at visits when aflibercept was not.
2.0 mg OPT-302: intravitreal injection
2.0 aflibercept: intravitreal injection
|
2.0 mg Aflibercept With Extended Dosing 2.0 mg OPT-302
n=330 Participants
2.0 mg aflibercept 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 3 treatments, and then at 8-weekly intervals through Week 96, with sham intravitreal injection administered alone into the study eye at the alternating visits when aflibercept and OPT-302 were not administered.
2.0 mg OPT-302: intravitreal injection
2.0 aflibercept: intravitreal injection
Sham: intravitreal injection
|
2.0 mg Aflibercept With Sham
n=330 Participants
2.0 mg aflibercept intravitreal injection (0.05mL) followed by sham intravitreal injection administered into the study eye at 4-weekly intervals for 3 treatments, and then at 8-weekly intervals through Week 96, with sham intravitreal injection administered alone at visits when aflibercept was not.
2.0 aflibercept: intravitreal injection
Sham: intravitreal injection
|
Total
n=993 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Sex: Female, Male
Female
|
190 Participants
n=5 Participants
|
183 Participants
n=7 Participants
|
184 Participants
n=5 Participants
|
557 Participants
n=4 Participants
|
|
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
|
39 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
105 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
294 Participants
n=5 Participants
|
298 Participants
n=7 Participants
|
296 Participants
n=5 Participants
|
888 Participants
n=4 Participants
|
|
Age, Continuous
|
74.3 years
STANDARD_DEVIATION 7.80 • n=5 Participants
|
74.9 years
STANDARD_DEVIATION 7.97 • n=7 Participants
|
75.2 years
STANDARD_DEVIATION 8.28 • n=5 Participants
|
74.8 years
STANDARD_DEVIATION 8.02 • n=4 Participants
|
|
Sex: Female, Male
Male
|
143 Participants
n=5 Participants
|
147 Participants
n=7 Participants
|
146 Participants
n=5 Participants
|
436 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
83 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
241 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
246 Participants
n=5 Participants
|
247 Participants
n=7 Participants
|
247 Participants
n=5 Participants
|
740 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
29 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
83 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
288 Participants
n=5 Participants
|
287 Participants
n=7 Participants
|
281 Participants
n=5 Participants
|
856 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
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Early Treatment Retinopathy Study (ETDRS) Best-Corrected Visual Acuity (BCVA) Letters
|
52.8 letters read
STANDARD_DEVIATION 9.04 • n=5 Participants
|
52.3 letters read
STANDARD_DEVIATION 9.63 • n=7 Participants
|
52.4 letters read
STANDARD_DEVIATION 9.65 • n=5 Participants
|
52.5 letters read
STANDARD_DEVIATION 9.44 • n=4 Participants
|
|
Choroidal Neovascularisation (CNV) Area by Fluorescein Angiography (FA)
|
6.16 mm^2
STANDARD_DEVIATION 3.277 • n=5 Participants
|
6.47 mm^2
STANDARD_DEVIATION 3.137 • n=7 Participants
|
6.54 mm^2
STANDARD_DEVIATION 3.185 • n=5 Participants
|
6.39 mm^2
STANDARD_DEVIATION 3.199 • 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 2.0 mg aflibercept, 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 |
2.0 mg Aflibercept With Standard Dosing 2.0 mg OPT-302
n=333 Participants
2.0 mg aflibercept 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 OPT-302 administered alone at visits when aflibercept was not.
2.0 mg OPT-302: intravitreal injection
2.0 aflibercept: intravitreal injection
|
2.0 mg Aflibercept With Extended Dosing 2.0 mg OPT-302
n=330 Participants
2.0 mg aflibercept 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 3 treatments, and then at 8-weekly intervals through Week 96, with sham intravitreal injection administered alone into the study eye at the alternating visits when aflibercept and OPT-302 were not administered.
2.0 mg OPT-302: intravitreal injection
2.0 aflibercept: intravitreal injection
Sham: intravitreal injection
|
2.0 mg Aflibercept With Sham
n=330 Participants
2.0 mg aflibercept intravitreal injection (0.05mL) followed by sham intravitreal injection administered into the study eye at 4-weekly intervals for 3 treatments, and then at 8-weekly intervals through Week 96, with sham intravitreal injection administered alone at visits when aflibercept was not.
2.0 aflibercept: intravitreal injection
Sham: intravitreal injection
|
|---|---|---|---|
|
Mean Change in Early Treatment Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) Letters
|
13.48 Letters read
Standard Error 0.729
|
12.82 Letters read
Standard Error 0.728
|
13.66 Letters read
Standard Error 0.728
|
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 2.0 mg aflibercept, 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. The secondary analysis presented used multiple imputation analysis assuming missing at random in the overall population.
Outcome measures
| Measure |
2.0 mg Aflibercept With Standard Dosing 2.0 mg OPT-302
n=307 Participants
2.0 mg aflibercept 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 OPT-302 administered alone at visits when aflibercept was not.
2.0 mg OPT-302: intravitreal injection
2.0 aflibercept: intravitreal injection
|
2.0 mg Aflibercept With Extended Dosing 2.0 mg OPT-302
n=298 Participants
2.0 mg aflibercept 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 3 treatments, and then at 8-weekly intervals through Week 96, with sham intravitreal injection administered alone into the study eye at the alternating visits when aflibercept and OPT-302 were not administered.
2.0 mg OPT-302: intravitreal injection
2.0 aflibercept: intravitreal injection
Sham: intravitreal injection
|
2.0 mg Aflibercept With Sham
n=303 Participants
2.0 mg aflibercept intravitreal injection (0.05mL) followed by sham intravitreal injection administered into the study eye at 4-weekly intervals for 3 treatments, and then at 8-weekly intervals through Week 96, with sham intravitreal injection administered alone at visits when aflibercept was not.
2.0 aflibercept: intravitreal injection
Sham: intravitreal injection
|
|---|---|---|---|
|
Proportion of Participants Gaining 15 or More ETDRS BCVA Letters
|
167 Participants
|
156 Participants
|
162 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 2.0 mg aflibercept, 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. The secondary analysis presented used multiple imputation analysis assuming missing at random in the overall population.
Outcome measures
| Measure |
2.0 mg Aflibercept With Standard Dosing 2.0 mg OPT-302
n=307 Participants
2.0 mg aflibercept 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 OPT-302 administered alone at visits when aflibercept was not.
2.0 mg OPT-302: intravitreal injection
2.0 aflibercept: intravitreal injection
|
2.0 mg Aflibercept With Extended Dosing 2.0 mg OPT-302
n=298 Participants
2.0 mg aflibercept 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 3 treatments, and then at 8-weekly intervals through Week 96, with sham intravitreal injection administered alone into the study eye at the alternating visits when aflibercept and OPT-302 were not administered.
2.0 mg OPT-302: intravitreal injection
2.0 aflibercept: intravitreal injection
Sham: intravitreal injection
|
2.0 mg Aflibercept With Sham
n=303 Participants
2.0 mg aflibercept intravitreal injection (0.05mL) followed by sham intravitreal injection administered into the study eye at 4-weekly intervals for 3 treatments, and then at 8-weekly intervals through Week 96, with sham intravitreal injection administered alone at visits when aflibercept was not.
2.0 aflibercept: intravitreal injection
Sham: intravitreal injection
|
|---|---|---|---|
|
Proportion of Participants Gaining 10 or More ETDRS BCVA Letters
|
204 Participants
|
197 Participants
|
204 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 2.0 mg aflibercept, 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. The secondary analysis presented used mixed model for repeated measures in the overall population.
Outcome measures
| Measure |
2.0 mg Aflibercept With Standard Dosing 2.0 mg OPT-302
n=290 Participants
2.0 mg aflibercept 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 OPT-302 administered alone at visits when aflibercept was not.
2.0 mg OPT-302: intravitreal injection
2.0 aflibercept: intravitreal injection
|
2.0 mg Aflibercept With Extended Dosing 2.0 mg OPT-302
n=279 Participants
2.0 mg aflibercept 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 3 treatments, and then at 8-weekly intervals through Week 96, with sham intravitreal injection administered alone into the study eye at the alternating visits when aflibercept and OPT-302 were not administered.
2.0 mg OPT-302: intravitreal injection
2.0 aflibercept: intravitreal injection
Sham: intravitreal injection
|
2.0 mg Aflibercept With Sham
n=281 Participants
2.0 mg aflibercept intravitreal injection (0.05mL) followed by sham intravitreal injection administered into the study eye at 4-weekly intervals for 3 treatments, and then at 8-weekly intervals through Week 96, with sham intravitreal injection administered alone at visits when aflibercept was not.
2.0 aflibercept: intravitreal injection
Sham: intravitreal injection
|
|---|---|---|---|
|
Change in Choroidal Neovascularisation (CNV) Area by Fluorescein Angiography (FA)
|
-4.91 mm^2
Standard Error 0.165
|
-4.92 mm^2
Standard Error 0.166
|
-4.61 mm^2
Standard Error 0.166
|
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 2.0 mg aflibercept, 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. The secondary analysis presented used multiple imputation analysis assuming missing at random in the overall population.
Outcome measures
| Measure |
2.0 mg Aflibercept With Standard Dosing 2.0 mg OPT-302
n=306 Participants
2.0 mg aflibercept 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 OPT-302 administered alone at visits when aflibercept was not.
2.0 mg OPT-302: intravitreal injection
2.0 aflibercept: intravitreal injection
|
2.0 mg Aflibercept With Extended Dosing 2.0 mg OPT-302
n=297 Participants
2.0 mg aflibercept 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 3 treatments, and then at 8-weekly intervals through Week 96, with sham intravitreal injection administered alone into the study eye at the alternating visits when aflibercept and OPT-302 were not administered.
2.0 mg OPT-302: intravitreal injection
2.0 aflibercept: intravitreal injection
Sham: intravitreal injection
|
2.0 mg Aflibercept With Sham
n=301 Participants
2.0 mg aflibercept intravitreal injection (0.05mL) followed by sham intravitreal injection administered into the study eye at 4-weekly intervals for 3 treatments, and then at 8-weekly intervals through Week 96, with sham intravitreal injection administered alone at visits when aflibercept was not.
2.0 aflibercept: intravitreal injection
Sham: intravitreal injection
|
|---|---|---|---|
|
Proportion of Participants With Absence of Both Sub-retinal Fluid and Intra-retinal Cysts by SD-OCT
|
30 Participants
|
32 Participants
|
29 Participants
|
Adverse Events
2.0 mg Aflibercept With Standard Dosing 2.0 mg OPT-302
Serious events: 71 serious events
Other events: 288 other events
Deaths: 9 deaths
2.0 mg Aflibercept With Extended Dosing 2.0 mg OPT-302
Serious events: 61 serious events
Other events: 290 other events
Deaths: 12 deaths
2.0 mg Aflibercept With Sham
Serious events: 68 serious events
Other events: 282 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
2.0 mg Aflibercept With Standard Dosing 2.0 mg OPT-302
n=333 participants at risk
2.0 mg aflibercept 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 OPT-302 administered alone at visits when aflibercept was not.
2.0 mg OPT-302: intravitreal injection
2.0 aflibercept: intravitreal injection
|
2.0 mg Aflibercept With Extended Dosing 2.0 mg OPT-302
n=330 participants at risk
2.0 mg aflibercept 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 3 treatments, and then at 8-weekly intervals through Week 96, with sham intravitreal injection administered alone into the study eye at the alternating visits when aflibercept and OPT-302 were not administered.
2.0 mg OPT-302: intravitreal injection
2.0 aflibercept: intravitreal injection
Sham: intravitreal injection
|
2.0 mg Aflibercept With Sham
n=330 participants at risk
2.0 mg aflibercept intravitreal injection (0.05mL) followed by sham intravitreal injection administered into the study eye at 4-weekly intervals for 3 treatments, and then at 8-weekly intervals through Week 96, with sham intravitreal injection administered alone at visits when aflibercept was not.
2.0 aflibercept: intravitreal injection
Sham: intravitreal injection
|
|---|---|---|---|
|
Eye disorders
Visual acuity reduced
|
0.60%
2/333 • 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.
|
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
Cataract
|
0.30%
1/333 • 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%
2/330 • 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.
|
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
Cataract nuclear
|
0.30%
1/333 • 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.
|
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
Cataract subcapsular
|
0.30%
1/333 • 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.
|
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
Lenticular opacities
|
0.30%
1/333 • 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.
|
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%
1/333 • 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.
|
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 haemorrhage
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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.
|
|
Eye disorders
Eye inflammation
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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
Uveitis
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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
Ocular hypertension
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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
Endophthalmitis
|
0.90%
3/333 • 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%
0/330 • 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.
|
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
Cataract traumatic
|
0.60%
2/333 • 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.
|
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
Anaemia
|
0.30%
1/333 • 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.
|
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
|
1.2%
4/333 • 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.
|
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
|
0.90%
3/333 • 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.
|
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
Atrial fibrillation
|
0.60%
2/333 • 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.
|
1.2%
4/330 • 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.
|
1.2%
4/330 • 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.
|
|
Cardiac disorders
Coronary artery disease
|
0.60%
2/333 • 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.
|
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
Supraventricular tachycardia
|
0.60%
2/333 • 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.
|
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
|
0.60%
2/333 • 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.
|
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 flutter
|
0.60%
2/333 • 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.
|
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 infarction
|
0.30%
1/333 • 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%
2/330 • 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.
|
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
|
0.30%
1/333 • 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.
|
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 congestive
|
0.30%
1/333 • 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%
0/330 • 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.
|
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
Angina unstable
|
0.30%
1/333 • 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.
|
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
Aortic valve incompetence
|
0.30%
1/333 • 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.
|
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
Left ventricular failure
|
0.30%
1/333 • 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.
|
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
Cardiogenic shock
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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
Sinus arrhythmia
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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
Acute left ventricular failure
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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
Degenerative multivalvular disease
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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
Myocardial ischaemia
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
0.30%
1/330 • 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.
|
|
Congenital, familial and genetic disorders
Hypertrophic cardiomyopathy
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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 pain
|
0.30%
1/333 • 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 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.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.30%
1/333 • 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.
|
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
Diarrhoea
|
0.30%
1/333 • 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.
|
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
Gastroduodenal ulcer
|
0.30%
1/333 • 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.
|
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
Gastrointestinal haemorrhage
|
0.30%
1/333 • 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.
|
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
Small intestinal haemorrhage
|
0.30%
1/333 • 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.
|
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%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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
Ascites
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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
Diverticulum intestinal haemorrhagic
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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
Enteritis
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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
Pancreatitis
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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
Food poisoning
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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
Gastritis
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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
Large intestinal stenosis
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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
Umbilical hernia
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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
Gait disturbance
|
0.30%
1/333 • 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.
|
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
Multiple organ dysfunction syndrome
|
0.30%
1/333 • 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.
|
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%
1/333 • 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.
|
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
Ulcer haemorrhage
|
0.30%
1/333 • 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.
|
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
Death
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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
Asthenia
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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
Malaise
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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
Bile duct stone
|
0.30%
1/333 • 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.
|
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
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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.
|
|
Infections and infestations
Pneumonia
|
2.1%
7/333 • Number of events 9 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
1.2%
4/330 • 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.
|
2.1%
7/330 • 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.
|
|
Infections and infestations
Sepsis
|
0.90%
3/333 • 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.
|
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
|
0.90%
3/333 • 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%
0/330 • 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.
|
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
|
0.30%
1/333 • 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.
|
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
|
0.30%
1/333 • 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.
|
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
|
0.30%
1/333 • 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.
|
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
Bacteriuria
|
0.30%
1/333 • 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.
|
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
|
0.30%
1/333 • 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.
|
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
Kidney infection
|
0.30%
1/333 • 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.
|
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 sepsis
|
0.30%
1/333 • 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.
|
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%
1/333 • 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.
|
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
Sinusitis fungal
|
0.30%
1/333 • 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.
|
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
Infective exacerbation of chronic obstructive airways disease
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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 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.
|
|
Infections and infestations
Complicated appendicitis
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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
Herpes zoster
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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
Peritonitis
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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
Urosepsis
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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
Viral infection
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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
Appendicitis perforated
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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
Cystitis
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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
Focal peritonitis
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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
Herpes simplex hepatitis
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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
Liver abscess
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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 viral
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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
Pyelonephritis
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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
Fall
|
0.60%
2/333 • 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.
|
0.61%
2/330 • 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.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.60%
2/333 • 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.
|
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
Subdural haematoma
|
0.60%
2/333 • 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.
|
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
Hip fracture
|
0.30%
1/333 • 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.
|
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
Femur fracture
|
0.30%
1/333 • 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.
|
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
Aortic injury
|
0.30%
1/333 • 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.
|
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
|
0.30%
1/333 • 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.
|
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
Upper limb fracture
|
0.30%
1/333 • 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.
|
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
Wrist fracture
|
0.30%
1/333 • 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.
|
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
Femoral neck fracture
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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
Pelvic fracture
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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
Traumatic haematoma
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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.
|
|
Investigations
Troponin increased
|
0.30%
1/333 • 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.
|
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
Dehydration
|
0.30%
1/333 • 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.
|
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
Diabetes mellitus
|
0.30%
1/333 • 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.
|
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
Hypokalaemia
|
0.30%
1/333 • 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.
|
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
Hypomagnesaemia
|
0.30%
1/333 • 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.
|
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
Hyponatraemia
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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
Arthritis
|
0.30%
1/333 • 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.
|
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
|
0.30%
1/333 • 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.
|
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
Osteoarthritis
|
0.30%
1/333 • 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.
|
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
|
0.30%
1/333 • 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.
|
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
Spinal stenosis
|
0.30%
1/333 • 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.
|
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)
Squamous cell carcinoma of lung
|
0.30%
1/333 • 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.
|
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)
Adenocarcinoma of colon
|
0.30%
1/333 • 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.
|
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 neoplasm
|
0.30%
1/333 • 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.
|
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)
Invasive breast cancer
|
0.30%
1/333 • 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.
|
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 stage IV
|
0.30%
1/333 • 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.
|
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
|
0.30%
1/333 • 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.
|
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)
Metastatic carcinoma of the bladder
|
0.30%
1/333 • 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.
|
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 metastatic
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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)
Breast cancer
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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)
Gastric cancer
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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)
Intraductal papillary mucinous neoplasm
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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)
Metastases to abdominal cavity
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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)
Metastases to peritoneum
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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)
Ovarian epithelial cancer
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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)
Sarcoma uterus
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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)
Spindle cell sarcoma
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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)
Adenocarcinoma of the cervix
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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)
Glioblastoma
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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)
Haemangioma of liver
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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)
Oesophageal adenocarcinoma
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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)
Oesophageal carcinoma
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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)
Ovarian cancer
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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)
Squamous cell carcinoma
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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)
Transitional cell carcinoma
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
0.30%
1/330 • 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.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.60%
2/333 • 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.
|
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
Ischaemic stroke
|
0.30%
1/333 • 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%
2/330 • 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.
|
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.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.30%
1/333 • 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 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
Encephalitis autoimmune
|
0.30%
1/333 • 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.
|
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
Essential tremor
|
0.30%
1/333 • 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.
|
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
Diabetic neuropathy
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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
Syncope
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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
Vertebrobasilar insufficiency
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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
Transient ischaemic attach
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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
Dementia
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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
Intracranial aneurysm
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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
Polyneuropathy
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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
Presyncope
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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
Vertebrobasilar stroke
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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
Alcoholism
|
0.30%
1/333 • 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.
|
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.
|
|
Psychiatric disorders
Bipolar I disorder
|
0.30%
1/333 • 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.
|
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.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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
|
0.60%
2/333 • 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.
|
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.
|
|
Renal and urinary disorders
Bladder tamponade
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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
Urinary retention
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.30%
1/333 • 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.
|
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.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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
|
0.60%
2/333 • 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.
|
0.30%
1/330 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.60%
2/333 • 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.
|
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.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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
Acute pulmonary oedema
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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 oedema
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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
Asthma
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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
Lung disorder
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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%
1/333 • 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.
|
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
Peripheral arterial occlusive disease
|
0.30%
1/333 • 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.
|
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
Varicose vein
|
0.30%
1/333 • 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.
|
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
Peripheral artery occlusion
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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
Aortic dissection
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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
Hypertensive emergency
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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 artery aneurysm
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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 artery thrombosis
|
0.00%
0/333 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least 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.
|
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 |
2.0 mg Aflibercept With Standard Dosing 2.0 mg OPT-302
n=333 participants at risk
2.0 mg aflibercept 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 OPT-302 administered alone at visits when aflibercept was not.
2.0 mg OPT-302: intravitreal injection
2.0 aflibercept: intravitreal injection
|
2.0 mg Aflibercept With Extended Dosing 2.0 mg OPT-302
n=330 participants at risk
2.0 mg aflibercept 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 3 treatments, and then at 8-weekly intervals through Week 96, with sham intravitreal injection administered alone into the study eye at the alternating visits when aflibercept and OPT-302 were not administered.
2.0 mg OPT-302: intravitreal injection
2.0 aflibercept: intravitreal injection
Sham: intravitreal injection
|
2.0 mg Aflibercept With Sham
n=330 participants at risk
2.0 mg aflibercept intravitreal injection (0.05mL) followed by sham intravitreal injection administered into the study eye at 4-weekly intervals for 3 treatments, and then at 8-weekly intervals through Week 96, with sham intravitreal injection administered alone at visits when aflibercept was not.
2.0 aflibercept: intravitreal injection
Sham: intravitreal injection
|
|---|---|---|---|
|
Eye disorders
Cataract
|
24.9%
83/333 • Number of events 87 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
18.8%
62/330 • Number of events 67 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at least one arm are reported; the Total Affected is the total number of participants experiencing at least one non-serious TEAE during the study.
|
14.2%
47/330 • Number of events 48 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at 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
|
5.4%
18/333 • 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.
|
2.7%
9/330 • Number of events 9 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at 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%
6/330 • 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.
|
|
Eye disorders
Conjunctival haemorrhage
|
5.1%
17/333 • 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.
|
7.3%
24/330 • 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.
|
3.9%
13/330 • 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
Visual acuity reduced
|
5.1%
17/333 • Number of events 19 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at 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%
6/330 • Number of events 8 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at 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 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.
|
|
Eye disorders
Eye pain
|
4.8%
16/333 • 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.
|
5.2%
17/330 • 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.
|
2.7%
9/330 • 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.
|
|
Eye disorders
Retinal degeneration
|
2.4%
8/333 • Number of events 9 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at 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.
|
5.2%
17/330 • 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.
|
|
Investigations
Intraocular pressure increased
|
9.6%
32/333 • 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.
|
9.4%
31/330 • Number of events 47 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at 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 17 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at 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
|
8.7%
29/333 • 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.
|
8.2%
27/330 • 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.
|
9.1%
30/330 • 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.
|
|
Infections and infestations
COVID-19
|
9.3%
31/333 • 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.
|
9.7%
32/330 • 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.
|
10.6%
35/330 • 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.
|
|
Infections and infestations
Nasopharyngitis
|
6.6%
22/333 • 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%
23/330 • 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.
|
8.8%
29/330 • Number of events 43 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at 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
|
5.4%
18/333 • 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.
|
7.6%
25/330 • 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 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
Influenza
|
5.1%
17/333 • 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.
|
3.6%
12/330 • 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.
|
5.2%
17/330 • 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
|
7.2%
24/333 • 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.
|
4.2%
14/330 • 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.
|
5.8%
19/330 • 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.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.1%
17/333 • 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.
|
3.3%
11/330 • 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.
|
3.9%
13/330 • Number of events 23 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at 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
|
5.4%
18/333 • 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.
|
5.8%
19/330 • 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.
|
5.8%
19/330 • 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.
|
|
Vascular disorders
Hypertension
|
3.6%
12/333 • 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.
|
3.6%
12/330 • 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.
|
9.4%
31/330 • Number of events 36 • From Baseline to Week 100
The safety dataset comprised all participants in the mITT dataset (all randomised participants with at least one dose of study medication). Participants were analysed according to the study medication received for all safety analyses. For Other (Not Including Serious) Adverse Events (AEs), non-serious AEs with a frequency greater than 5% within at 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