Trial Outcomes & Findings for Evaluate SLN360 in Participants With Elevated Lipoprotein(a) at High Risk of Atherosclerotic Cardiovascular Disease Events (NCT NCT05537571)
NCT ID: NCT05537571
Last Updated: 2025-07-01
Results Overview
Clinical trial results (relative to Day 1 pre-dose) was calculated for each participant by estimating the sum of the area under the curve with the linear trapezoidal method for all scheduled assessments from Week 4 to Week 36, inclusive, divided by the total time interval between the Week 4 and Week 36 assessments. Analysis of variance was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure. Time-averaged percent change in lipoprotein(a) to Week 36 was the dependent variable, and treatment group was included as the predictor variable. The least squares means, standard errors, and 2-sided 95% confidence intervals for each treatment group and for the pairwise comparisons between the SLN360 and placebo groups were estimated.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
180 participants
Primary outcome timeframe
Week 36
Results posted on
2025-07-01
Participant Flow
Participants were screened from 05 December 2022, first randomised participant signed informed consent on 13 December 2022 and last participant was randomised 27 April 2023.
A total of 253 participants were screened for inclusion, 73 participants failed screening.
Participant milestones
| Measure |
SLN360 300 mg Q16W
SLN360 300 mg administered subcutaneously at Weeks 0, 16 and 32 (Q16W)
SLN360: SLN360 is a double-stranded small interfering ribonucleic acid (siRNA) targeting LPA messenger RNA (mRNA)
|
SLN360 300 mg Q24W
SLN360 300 mg administered subcutaneously at Weeks 0 and 24 (Q24W)
SLN360: SLN360 is a double-stranded small interfering ribonucleic acid (siRNA) targeting LPA messenger RNA (mRNA)
|
SLN360 450 mg Q24W
SLN360 450 mg administered subcutaneously at Weeks 0 and 24 (Q24W)
SLN360: SLN360 is a double-stranded small interfering ribonucleic acid (siRNA) targeting LPA messenger RNA (mRNA)
|
Placebo Q16W
Placebo administered subcutaneously at Weeks 0, 16 and 32 (Q16W)
Placebo: Sodium chloride, solution for injection
|
Placebo Q24W
Placebo administered subcutaneously at Weeks 0 and 24 (Q24W). This group was stratified so that half of participants were dosed to match the SLN360 300 mg Q24W group and half were dosed to match the SLN360 450 mg Q24W group (with respect to injected volume)
Placebo: Sodium chloride, solution for injection
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
44
|
44
|
45
|
23
|
24
|
|
Overall Study
COMPLETED
|
39
|
43
|
44
|
23
|
23
|
|
Overall Study
NOT COMPLETED
|
5
|
1
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
SLN360 300 mg Q16W
SLN360 300 mg administered subcutaneously at Weeks 0, 16 and 32 (Q16W)
SLN360: SLN360 is a double-stranded small interfering ribonucleic acid (siRNA) targeting LPA messenger RNA (mRNA)
|
SLN360 300 mg Q24W
SLN360 300 mg administered subcutaneously at Weeks 0 and 24 (Q24W)
SLN360: SLN360 is a double-stranded small interfering ribonucleic acid (siRNA) targeting LPA messenger RNA (mRNA)
|
SLN360 450 mg Q24W
SLN360 450 mg administered subcutaneously at Weeks 0 and 24 (Q24W)
SLN360: SLN360 is a double-stranded small interfering ribonucleic acid (siRNA) targeting LPA messenger RNA (mRNA)
|
Placebo Q16W
Placebo administered subcutaneously at Weeks 0, 16 and 32 (Q16W)
Placebo: Sodium chloride, solution for injection
|
Placebo Q24W
Placebo administered subcutaneously at Weeks 0 and 24 (Q24W). This group was stratified so that half of participants were dosed to match the SLN360 300 mg Q24W group and half were dosed to match the SLN360 450 mg Q24W group (with respect to injected volume)
Placebo: Sodium chloride, solution for injection
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
2
|
0
|
0
|
0
|
0
|
|
Overall Study
Hepatitis A screening result
|
2
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
1
|
Baseline Characteristics
Evaluate SLN360 in Participants With Elevated Lipoprotein(a) at High Risk of Atherosclerotic Cardiovascular Disease Events
Baseline characteristics by cohort
| Measure |
SLN360 300 mg Q16W
n=42 Participants
SLN360 300 mg administered subcutaneously at Weeks 0, 16 and 32 (Q16W)
SLN360: SLN360 is a double-stranded small interfering ribonucleic acid (siRNA) targeting LPA messenger RNA (mRNA)
|
SLN360 300 mg Q24W
n=44 Participants
SLN360 300 mg administered subcutaneously at Weeks 0 and 24 (Q24W)
SLN360: SLN360 is a double-stranded small interfering ribonucleic acid (siRNA) targeting LPA messenger RNA (mRNA)
|
SLN360 450 mg Q24W
n=45 Participants
SLN360 450 mg administered subcutaneously at Weeks 0 and 24 (Q24W)
SLN360: SLN360 is a double-stranded small interfering ribonucleic acid (siRNA) targeting LPA messenger RNA (mRNA)
|
Placebo Q16W
n=23 Participants
Placebo administered subcutaneously at Weeks 0, 16 and 32 (dosing every 16 weeks \[Q16W\])
Placebo: Sodium chloride, solution for injection
|
Placebo Q24W
n=24 Participants
Placebo administered subcutaneously at Weeks 0 and 24 (dosing every 24 weeks \[Q24W\]). This group was stratified so that half of participants were dosed to match the SLN360 300 mg Q24W group and half were dosed to match the SLN360 450 mg Q24W group (with respect to injected volume).
Placebo: Sodium chloride, solution for injection
|
Total
n=178 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
91 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
23 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
87 Participants
n=10 Participants
|
|
Age, Continuous
|
63.1 years
STANDARD_DEVIATION 9.81 • n=5 Participants
|
64.5 years
STANDARD_DEVIATION 8.67 • n=7 Participants
|
63.8 years
STANDARD_DEVIATION 10.23 • n=5 Participants
|
65.0 years
STANDARD_DEVIATION 8.79 • n=4 Participants
|
62.1 years
STANDARD_DEVIATION 9.43 • n=21 Participants
|
63.7 years
STANDARD_DEVIATION 9.41 • n=10 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
46 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
132 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
178 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
8 Participants
n=10 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
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
153 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
13 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Region of Enrollment
Netherlands
|
13 participants
n=5 Participants
|
15 participants
n=7 Participants
|
16 participants
n=5 Participants
|
8 participants
n=4 Participants
|
8 participants
n=21 Participants
|
60 participants
n=10 Participants
|
|
Region of Enrollment
Czechia
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
3 participants
n=4 Participants
|
3 participants
n=21 Participants
|
11 participants
n=10 Participants
|
|
Region of Enrollment
Denmark
|
7 participants
n=5 Participants
|
9 participants
n=7 Participants
|
3 participants
n=5 Participants
|
3 participants
n=4 Participants
|
3 participants
n=21 Participants
|
25 participants
n=10 Participants
|
|
Region of Enrollment
United Kingdom
|
9 participants
n=5 Participants
|
6 participants
n=7 Participants
|
9 participants
n=5 Participants
|
5 participants
n=4 Participants
|
3 participants
n=21 Participants
|
32 participants
n=10 Participants
|
|
Region of Enrollment
South Africa
|
6 participants
n=5 Participants
|
8 participants
n=7 Participants
|
9 participants
n=5 Participants
|
3 participants
n=4 Participants
|
3 participants
n=21 Participants
|
29 participants
n=10 Participants
|
|
Region of Enrollment
Slovakia
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
5 participants
n=10 Participants
|
|
Region of Enrollment
Australia
|
3 participants
n=5 Participants
|
5 participants
n=7 Participants
|
3 participants
n=5 Participants
|
1 participants
n=4 Participants
|
4 participants
n=21 Participants
|
16 participants
n=10 Participants
|
|
Time from the initial date of elevated Lipoprotein(a) to randomisation date
|
6.10 months
n=5 Participants
|
5.45 months
n=7 Participants
|
3.70 months
n=5 Participants
|
3.60 months
n=4 Participants
|
5.35 months
n=21 Participants
|
4.45 months
n=10 Participants
|
|
Weight
|
84.15 kilograms
n=5 Participants
|
82.60 kilograms
n=7 Participants
|
80.20 kilograms
n=5 Participants
|
81.00 kilograms
n=4 Participants
|
84.10 kilograms
n=21 Participants
|
82.85 kilograms
n=10 Participants
|
|
Body Mass Index
|
27.060 kg/m2
n=5 Participants
|
28.240 kg/m2
n=7 Participants
|
26.470 kg/m2
n=5 Participants
|
26.930 kg/m2
n=4 Participants
|
26.160 kg/m2
n=21 Participants
|
26.905 kg/m2
n=10 Participants
|
|
Height
|
177.0 centimetres
n=5 Participants
|
175.0 centimetres
n=7 Participants
|
173.0 centimetres
n=5 Participants
|
170.0 centimetres
n=4 Participants
|
174.5 centimetres
n=21 Participants
|
175.0 centimetres
n=10 Participants
|
PRIMARY outcome
Timeframe: Week 36Population: The pharmacodynamic population included all participants who received at least 1 dose of study drug and had evaluable pharmacodynamic data.
Clinical trial results (relative to Day 1 pre-dose) was calculated for each participant by estimating the sum of the area under the curve with the linear trapezoidal method for all scheduled assessments from Week 4 to Week 36, inclusive, divided by the total time interval between the Week 4 and Week 36 assessments. Analysis of variance was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure. Time-averaged percent change in lipoprotein(a) to Week 36 was the dependent variable, and treatment group was included as the predictor variable. The least squares means, standard errors, and 2-sided 95% confidence intervals for each treatment group and for the pairwise comparisons between the SLN360 and placebo groups were estimated.
Outcome measures
| Measure |
SLN360 300 mg Q16W
n=42 Participants
SLN360 300 mg administered subcutaneously at Weeks 0, 16 and 32 (Q16W)
SLN360: SLN360 is a double-stranded small interfering ribonucleic acid (siRNA) targeting LPA messenger RNA (mRNA)
|
SLN360 300 mg Q24W
n=44 Participants
SLN360 300 mg administered subcutaneously at Weeks 0 and 24 (Q24W)
SLN360: SLN360 is a double-stranded small interfering ribonucleic acid (siRNA) targeting LPA messenger RNA (mRNA)
|
SLN360 450 mg Q24W
n=45 Participants
SLN360 450 mg administered subcutaneously at Weeks 0 and 24 (Q24W)
SLN360: SLN360 is a double-stranded small interfering ribonucleic acid (siRNA) targeting LPA messenger RNA (mRNA)
|
Pooled Placebo
n=47 Participants
Pooled data from both placebo groups
Placebo: Sodium chloride, solution for injection
|
|---|---|---|---|---|
|
Time-averaged Percent Change In Lipoprotein(a) Molar Concentration From Baseline to Week 36
|
-80.5 Percentage
Standard Error 1.99
|
-79.1 Percentage
Standard Error 1.94
|
-83.3 Percentage
Standard Error 1.92
|
2.3 Percentage
Standard Error 1.88
|
SECONDARY outcome
Timeframe: Week 48Population: The pharmacodynamic population included all participants who received at least 1 dose of study drug and had evaluable pharmacodynamic data.
Time-averaged secondary endpoints were calculated and analysed using the same conventions as the primary endpoint.
Outcome measures
| Measure |
SLN360 300 mg Q16W
n=42 Participants
SLN360 300 mg administered subcutaneously at Weeks 0, 16 and 32 (Q16W)
SLN360: SLN360 is a double-stranded small interfering ribonucleic acid (siRNA) targeting LPA messenger RNA (mRNA)
|
SLN360 300 mg Q24W
n=44 Participants
SLN360 300 mg administered subcutaneously at Weeks 0 and 24 (Q24W)
SLN360: SLN360 is a double-stranded small interfering ribonucleic acid (siRNA) targeting LPA messenger RNA (mRNA)
|
SLN360 450 mg Q24W
n=45 Participants
SLN360 450 mg administered subcutaneously at Weeks 0 and 24 (Q24W)
SLN360: SLN360 is a double-stranded small interfering ribonucleic acid (siRNA) targeting LPA messenger RNA (mRNA)
|
Pooled Placebo
n=47 Participants
Pooled data from both placebo groups
Placebo: Sodium chloride, solution for injection
|
|---|---|---|---|---|
|
Time-averaged Percent Change In Lipoprotein(a) Molar Concentration From Baseline to Week 48
|
-81.6 Percentage
Standard Error 2.05
|
-77.2 Percentage
Standard Error 2.00
|
-81.5 Percentage
Standard Error 1.98
|
1.5 Percentage
Standard Error 1.94
|
SECONDARY outcome
Timeframe: Week 60Population: The pharmacodynamic population included all participants who received at least 1 dose of study drug and had evaluable pharmacodynamic data.
Time-averaged secondary endpoints were calculated and analysed using the same conventions as the primary endpoint.
Outcome measures
| Measure |
SLN360 300 mg Q16W
n=42 Participants
SLN360 300 mg administered subcutaneously at Weeks 0, 16 and 32 (Q16W)
SLN360: SLN360 is a double-stranded small interfering ribonucleic acid (siRNA) targeting LPA messenger RNA (mRNA)
|
SLN360 300 mg Q24W
n=44 Participants
SLN360 300 mg administered subcutaneously at Weeks 0 and 24 (Q24W)
SLN360: SLN360 is a double-stranded small interfering ribonucleic acid (siRNA) targeting LPA messenger RNA (mRNA)
|
SLN360 450 mg Q24W
n=45 Participants
SLN360 450 mg administered subcutaneously at Weeks 0 and 24 (Q24W)
SLN360: SLN360 is a double-stranded small interfering ribonucleic acid (siRNA) targeting LPA messenger RNA (mRNA)
|
Pooled Placebo
n=47 Participants
Pooled data from both placebo groups
Placebo: Sodium chloride, solution for injection
|
|---|---|---|---|---|
|
Time-averaged Percent Change In Lipoprotein(a) Molar Concentration From Baseline to Week 60
|
-78.0 Percentage
Standard Error 2.24
|
-70.7 Percentage
Standard Error 2.19
|
-76.0 Percentage
Standard Error 2.16
|
1.1 Percentage
Standard Error 2.11
|
SECONDARY outcome
Timeframe: Week 36Population: The pharmacodynamic population included all participants who received at least 1 dose of study drug and had evaluable pharmacodynamic data.
Time-averaged secondary endpoints were calculated and analysed using the same conventions as the primary endpoint.
Outcome measures
| Measure |
SLN360 300 mg Q16W
n=42 Participants
SLN360 300 mg administered subcutaneously at Weeks 0, 16 and 32 (Q16W)
SLN360: SLN360 is a double-stranded small interfering ribonucleic acid (siRNA) targeting LPA messenger RNA (mRNA)
|
SLN360 300 mg Q24W
n=44 Participants
SLN360 300 mg administered subcutaneously at Weeks 0 and 24 (Q24W)
SLN360: SLN360 is a double-stranded small interfering ribonucleic acid (siRNA) targeting LPA messenger RNA (mRNA)
|
SLN360 450 mg Q24W
n=45 Participants
SLN360 450 mg administered subcutaneously at Weeks 0 and 24 (Q24W)
SLN360: SLN360 is a double-stranded small interfering ribonucleic acid (siRNA) targeting LPA messenger RNA (mRNA)
|
Pooled Placebo
n=47 Participants
Pooled data from both placebo groups
Placebo: Sodium chloride, solution for injection
|
|---|---|---|---|---|
|
Time-averaged Percent Change In Apolipoprotein B Concentration From Baseline to Week 36
|
-16.9 Percentage
Standard Error 1.93
|
-13.5 Percentage
Standard Error 1.88
|
-18.6 Percentage
Standard Error 1.86
|
-3.6 Percentage
Standard Error 1.82
|
SECONDARY outcome
Timeframe: Week 48Population: The pharmacodynamic population included all participants who received at least 1 dose of study drug and had evaluable pharmacodynamic data.
Time-averaged secondary endpoints were calculated and analysed using the same conventions as the primary endpoint.
Outcome measures
| Measure |
SLN360 300 mg Q16W
n=42 Participants
SLN360 300 mg administered subcutaneously at Weeks 0, 16 and 32 (Q16W)
SLN360: SLN360 is a double-stranded small interfering ribonucleic acid (siRNA) targeting LPA messenger RNA (mRNA)
|
SLN360 300 mg Q24W
n=44 Participants
SLN360 300 mg administered subcutaneously at Weeks 0 and 24 (Q24W)
SLN360: SLN360 is a double-stranded small interfering ribonucleic acid (siRNA) targeting LPA messenger RNA (mRNA)
|
SLN360 450 mg Q24W
n=45 Participants
SLN360 450 mg administered subcutaneously at Weeks 0 and 24 (Q24W)
SLN360: SLN360 is a double-stranded small interfering ribonucleic acid (siRNA) targeting LPA messenger RNA (mRNA)
|
Pooled Placebo
n=47 Participants
Pooled data from both placebo groups
Placebo: Sodium chloride, solution for injection
|
|---|---|---|---|---|
|
Time-averaged Percent Change In Apolipoprotein B Concentration From Baseline to Week 48
|
-16.4 Percentage
Standard Error 1.94
|
-12.6 Percentage
Standard Error 1.90
|
-18.0 Percentage
Standard Error 1.88
|
-4.0 Percentage
Standard Error 1.83
|
SECONDARY outcome
Timeframe: Week 60Population: The pharmacodynamic population included all participants who received at least 1 dose of study drug and had evaluable pharmacodynamic data.
Time-averaged secondary endpoints were calculated and analysed using the same conventions as the primary endpoint.
Outcome measures
| Measure |
SLN360 300 mg Q16W
n=42 Participants
SLN360 300 mg administered subcutaneously at Weeks 0, 16 and 32 (Q16W)
SLN360: SLN360 is a double-stranded small interfering ribonucleic acid (siRNA) targeting LPA messenger RNA (mRNA)
|
SLN360 300 mg Q24W
n=44 Participants
SLN360 300 mg administered subcutaneously at Weeks 0 and 24 (Q24W)
SLN360: SLN360 is a double-stranded small interfering ribonucleic acid (siRNA) targeting LPA messenger RNA (mRNA)
|
SLN360 450 mg Q24W
n=45 Participants
SLN360 450 mg administered subcutaneously at Weeks 0 and 24 (Q24W)
SLN360: SLN360 is a double-stranded small interfering ribonucleic acid (siRNA) targeting LPA messenger RNA (mRNA)
|
Pooled Placebo
n=47 Participants
Pooled data from both placebo groups
Placebo: Sodium chloride, solution for injection
|
|---|---|---|---|---|
|
Time-averaged Percent Change In Apolipoprotein B Concentration From Baseline to Week 60
|
-15.0 Percentage
Standard Error 2.04
|
-10.9 Percentage
Standard Error 1.99
|
-16.4 Percentage
Standard Error 1.97
|
-3.8 Percentage
Standard Error 1.93
|
SECONDARY outcome
Timeframe: Week 36Population: The pharmacodynamic population included all participants who received at least 1 dose of study drug and had evaluable pharmacodynamic data.
Time-averaged secondary endpoints were calculated and analysed using the same conventions as the primary endpoint.
Outcome measures
| Measure |
SLN360 300 mg Q16W
n=42 Participants
SLN360 300 mg administered subcutaneously at Weeks 0, 16 and 32 (Q16W)
SLN360: SLN360 is a double-stranded small interfering ribonucleic acid (siRNA) targeting LPA messenger RNA (mRNA)
|
SLN360 300 mg Q24W
n=44 Participants
SLN360 300 mg administered subcutaneously at Weeks 0 and 24 (Q24W)
SLN360: SLN360 is a double-stranded small interfering ribonucleic acid (siRNA) targeting LPA messenger RNA (mRNA)
|
SLN360 450 mg Q24W
n=45 Participants
SLN360 450 mg administered subcutaneously at Weeks 0 and 24 (Q24W)
SLN360: SLN360 is a double-stranded small interfering ribonucleic acid (siRNA) targeting LPA messenger RNA (mRNA)
|
Pooled Placebo
n=47 Participants
Pooled data from both placebo groups
Placebo: Sodium chloride, solution for injection
|
|---|---|---|---|---|
|
Time-averaged Percent Change In Low-density Lipoprotein Cholesterol Concentration From Baseline to Week 36
|
-22.3 Percentage
Standard Error 8.16
|
-20.1 Percentage
Standard Error 7.98
|
-15.5 Percentage
Standard Error 7.89
|
9.6 Percentage
Standard Error 7.72
|
SECONDARY outcome
Timeframe: Week 48Population: The pharmacodynamic population included all participants who received at least 1 dose of study drug and had evaluable pharmacodynamic data.
Time-averaged secondary endpoints were calculated and analysed using the same conventions as the primary endpoint.
Outcome measures
| Measure |
SLN360 300 mg Q16W
n=42 Participants
SLN360 300 mg administered subcutaneously at Weeks 0, 16 and 32 (Q16W)
SLN360: SLN360 is a double-stranded small interfering ribonucleic acid (siRNA) targeting LPA messenger RNA (mRNA)
|
SLN360 300 mg Q24W
n=44 Participants
SLN360 300 mg administered subcutaneously at Weeks 0 and 24 (Q24W)
SLN360: SLN360 is a double-stranded small interfering ribonucleic acid (siRNA) targeting LPA messenger RNA (mRNA)
|
SLN360 450 mg Q24W
n=45 Participants
SLN360 450 mg administered subcutaneously at Weeks 0 and 24 (Q24W)
SLN360: SLN360 is a double-stranded small interfering ribonucleic acid (siRNA) targeting LPA messenger RNA (mRNA)
|
Pooled Placebo
n=47 Participants
Pooled data from both placebo groups
Placebo: Sodium chloride, solution for injection
|
|---|---|---|---|---|
|
Time-averaged Percent Change In Low-density Lipoprotein Cholesterol Concentration From Baseline to Week 48
|
-20.9 Percentage
Standard Error 7.01
|
-18.5 Percentage
Standard Error 6.85
|
-17.0 Percentage
Standard Error 6.78
|
8.9 Percentage
Standard Error 6.63
|
SECONDARY outcome
Timeframe: Week 60Population: The pharmacodynamic population included all participants who received at least 1 dose of study drug and had evaluable pharmacodynamic data.
Time-averaged secondary endpoints were calculated and analysed using the same conventions as the primary endpoint.
Outcome measures
| Measure |
SLN360 300 mg Q16W
n=42 Participants
SLN360 300 mg administered subcutaneously at Weeks 0, 16 and 32 (Q16W)
SLN360: SLN360 is a double-stranded small interfering ribonucleic acid (siRNA) targeting LPA messenger RNA (mRNA)
|
SLN360 300 mg Q24W
n=44 Participants
SLN360 300 mg administered subcutaneously at Weeks 0 and 24 (Q24W)
SLN360: SLN360 is a double-stranded small interfering ribonucleic acid (siRNA) targeting LPA messenger RNA (mRNA)
|
SLN360 450 mg Q24W
n=45 Participants
SLN360 450 mg administered subcutaneously at Weeks 0 and 24 (Q24W)
SLN360: SLN360 is a double-stranded small interfering ribonucleic acid (siRNA) targeting LPA messenger RNA (mRNA)
|
Pooled Placebo
n=47 Participants
Pooled data from both placebo groups
Placebo: Sodium chloride, solution for injection
|
|---|---|---|---|---|
|
Time-averaged Percent Change In Low-density Lipoprotein Cholesterol Concentration From Baseline to Week 60
|
-19.3 Percentage
Standard Error 7.45
|
-16.8 Percentage
Standard Error 7.28
|
-14.7 Percentage
Standard Error 7.19
|
9.3 Percentage
Standard Error 7.04
|
Adverse Events
SLN360 300 mg Q16W
Serious events: 6 serious events
Other events: 42 other events
Deaths: 0 deaths
SLN360 300 mg Q24W
Serious events: 2 serious events
Other events: 43 other events
Deaths: 0 deaths
SLN360 450 mg Q24W
Serious events: 5 serious events
Other events: 42 other events
Deaths: 0 deaths
Placebo Q16W
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Placebo Q24W
Serious events: 3 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SLN360 300 mg Q16W
n=42 participants at risk
SLN360 300 mg administered subcutaneously at Weeks 0, 16 and 32 (Q16W).
SLN360: SLN360 is a double-stranded small interfering ribonucleic acid (siRNA) targeting LPA messenger RNA (mRNA)
|
SLN360 300 mg Q24W
n=44 participants at risk
SLN360 300 mg administered subcutaneously at Weeks 0 and 24 (Q24W).
SLN360: SLN360 is a double-stranded small interfering ribonucleic acid (siRNA) targeting LPA messenger RNA (mRNA)
|
SLN360 450 mg Q24W
n=45 participants at risk
SLN360 450 mg administered subcutaneously at Weeks 0 and 24 (Q24W).
SLN360: SLN360 is a double-stranded small interfering ribonucleic acid (siRNA) targeting LPA messenger RNA (mRNA)
|
Placebo Q16W
n=23 participants at risk
Placebo administered subcutaneously at Weeks 0, 16 and 32 (dosing every 16 weeks \[Q16W\]).
Placebo: Sodium chloride, solution for injection
|
Placebo Q24W
n=24 participants at risk
Placebo administered subcutaneously at Weeks 0 and 24 (dosing every 24 weeks \[Q24W\]). This group was stratified so that half of participants were dosed to match the SLN360 300 mg Q24W group and half were dosed to match the SLN360 450 mg Q24W group (with respect to injected volume).
Placebo: Sodium chloride, solution for injection
|
|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
2.4%
1/42 • Number of events 1 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/44 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/45 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/23 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/24 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant polyp
|
0.00%
0/42 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/44 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
2.2%
1/45 • Number of events 1 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/23 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/24 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
|
Vascular disorders
Hypertension
|
2.4%
1/42 • Number of events 1 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/44 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/45 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/23 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/24 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/42 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
2.3%
1/44 • Number of events 1 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
2.2%
1/45 • Number of events 1 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/23 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/24 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/42 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/44 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
2.2%
1/45 • Number of events 1 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/23 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/24 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/42 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/44 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/45 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
4.3%
1/23 • Number of events 1 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/24 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
|
Nervous system disorders
Acute vestibular syndrome
|
0.00%
0/42 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/44 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
2.2%
1/45 • Number of events 1 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/23 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/24 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/42 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/44 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/45 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/23 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
4.2%
1/24 • Number of events 1 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.4%
1/42 • Number of events 1 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/44 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/45 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/23 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/24 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/42 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
2.3%
1/44 • Number of events 1 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/45 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/23 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/24 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.4%
1/42 • Number of events 1 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/44 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/45 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/23 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/24 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.4%
1/42 • Number of events 1 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/44 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/45 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/23 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/24 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
|
Musculoskeletal and connective tissue disorders
Polymyositis
|
2.4%
1/42 • Number of events 1 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/44 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/45 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/23 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/24 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
|
Infections and infestations
Pneumonia
|
2.4%
1/42 • Number of events 1 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/44 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
2.2%
1/45 • Number of events 1 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/23 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/24 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
|
Infections and infestations
Lymph node tuberculosis
|
2.4%
1/42 • Number of events 1 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/44 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/45 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/23 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/24 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
|
Infections and infestations
Viral infection
|
0.00%
0/42 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/44 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
2.2%
1/45 • Number of events 1 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/23 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/24 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/42 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/44 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/45 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/23 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
4.2%
1/24 • Number of events 1 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/42 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/44 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/45 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/23 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
4.2%
1/24 • Number of events 1 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
Other adverse events
| Measure |
SLN360 300 mg Q16W
n=42 participants at risk
SLN360 300 mg administered subcutaneously at Weeks 0, 16 and 32 (Q16W).
SLN360: SLN360 is a double-stranded small interfering ribonucleic acid (siRNA) targeting LPA messenger RNA (mRNA)
|
SLN360 300 mg Q24W
n=44 participants at risk
SLN360 300 mg administered subcutaneously at Weeks 0 and 24 (Q24W).
SLN360: SLN360 is a double-stranded small interfering ribonucleic acid (siRNA) targeting LPA messenger RNA (mRNA)
|
SLN360 450 mg Q24W
n=45 participants at risk
SLN360 450 mg administered subcutaneously at Weeks 0 and 24 (Q24W).
SLN360: SLN360 is a double-stranded small interfering ribonucleic acid (siRNA) targeting LPA messenger RNA (mRNA)
|
Placebo Q16W
n=23 participants at risk
Placebo administered subcutaneously at Weeks 0, 16 and 32 (dosing every 16 weeks \[Q16W\]).
Placebo: Sodium chloride, solution for injection
|
Placebo Q24W
n=24 participants at risk
Placebo administered subcutaneously at Weeks 0 and 24 (dosing every 24 weeks \[Q24W\]). This group was stratified so that half of participants were dosed to match the SLN360 300 mg Q24W group and half were dosed to match the SLN360 450 mg Q24W group (with respect to injected volume).
Placebo: Sodium chloride, solution for injection
|
|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Procedural pain
|
9.5%
4/42 • Number of events 8 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
2.3%
1/44 • Number of events 1 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
4.4%
2/45 • Number of events 4 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
4.3%
1/23 • Number of events 2 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/24 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
|
Vascular disorders
Hypertension
|
0.00%
0/42 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
2.3%
1/44 • Number of events 1 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
4.4%
2/45 • Number of events 2 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
8.7%
2/23 • Number of events 2 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/24 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
|
Cardiac disorders
Angina pectoris
|
2.4%
1/42 • Number of events 1 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
2.3%
1/44 • Number of events 2 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
4.4%
2/45 • Number of events 2 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
8.7%
2/23 • Number of events 2 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
12.5%
3/24 • Number of events 3 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
|
Nervous system disorders
Dizziness
|
7.1%
3/42 • Number of events 3 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
9.1%
4/44 • Number of events 5 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
2.2%
1/45 • Number of events 1 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
4.3%
1/23 • Number of events 1 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
4.2%
1/24 • Number of events 1 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
|
Nervous system disorders
Headache
|
11.9%
5/42 • Number of events 5 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
6.8%
3/44 • Number of events 5 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
13.3%
6/45 • Number of events 8 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
4.3%
1/23 • Number of events 1 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
4.2%
1/24 • Number of events 1 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
|
General disorders
Fatigue
|
0.00%
0/42 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
9.1%
4/44 • Number of events 4 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
2.2%
1/45 • Number of events 1 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
8.7%
2/23 • Number of events 2 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
4.2%
1/24 • Number of events 1 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
|
General disorders
Influenza-like illness
|
4.8%
2/42 • Number of events 2 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
2.3%
1/44 • Number of events 1 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
15.6%
7/45 • Number of events 7 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/23 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
4.2%
1/24 • Number of events 1 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
|
General disorders
Injection site reaction
|
83.3%
35/42 • Number of events 71 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
81.8%
36/44 • Number of events 55 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
82.2%
37/45 • Number of events 109 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
8.7%
2/23 • Number of events 3 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
8.3%
2/24 • Number of events 2 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
|
General disorders
Malaise
|
14.3%
6/42 • Number of events 8 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/44 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
8.9%
4/45 • Number of events 5 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/23 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
4.2%
1/24 • Number of events 1 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.4%
1/42 • Number of events 2 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
2.3%
1/44 • Number of events 1 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
2.2%
1/45 • Number of events 1 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
4.3%
1/23 • Number of events 1 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
8.3%
2/24 • Number of events 2 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/42 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/44 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
2.2%
1/45 • Number of events 1 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
8.7%
2/23 • Number of events 2 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/24 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/42 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/44 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/45 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
8.7%
2/23 • Number of events 2 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
4.2%
1/24 • Number of events 1 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
|
General disorders
Oedema peripheral
|
0.00%
0/42 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/44 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
4.4%
2/45 • Number of events 2 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
4.3%
1/23 • Number of events 1 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
8.3%
2/24 • Number of events 3 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
|
Gastrointestinal disorders
Nausea
|
2.4%
1/42 • Number of events 1 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
2.3%
1/44 • Number of events 1 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
2.2%
1/45 • Number of events 1 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
4.3%
1/23 • Number of events 2 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
8.3%
2/24 • Number of events 2 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/42 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
4.5%
2/44 • Number of events 2 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/45 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/23 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
8.3%
2/24 • Number of events 2 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.1%
3/42 • Number of events 4 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
9.1%
4/44 • Number of events 4 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
4.4%
2/45 • Number of events 2 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
8.7%
2/23 • Number of events 2 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/24 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.8%
2/42 • Number of events 2 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
4.5%
2/44 • Number of events 2 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/45 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
8.7%
2/23 • Number of events 2 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/24 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.4%
1/42 • Number of events 2 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
2.3%
1/44 • Number of events 1 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
15.6%
7/45 • Number of events 8 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
4.3%
1/23 • Number of events 1 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
4.2%
1/24 • Number of events 1 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.4%
1/42 • Number of events 1 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
2.3%
1/44 • Number of events 1 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/45 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/23 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
8.3%
2/24 • Number of events 2 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.8%
2/42 • Number of events 2 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
2.3%
1/44 • Number of events 1 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
6.7%
3/45 • Number of events 3 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/23 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/24 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
|
Infections and infestations
COVID-19
|
4.8%
2/42 • Number of events 2 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
13.6%
6/44 • Number of events 7 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
8.9%
4/45 • Number of events 4 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
13.0%
3/23 • Number of events 3 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
16.7%
4/24 • Number of events 4 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
|
Infections and infestations
Nasopharyngitis
|
7.1%
3/42 • Number of events 3 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
13.6%
6/44 • Number of events 8 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
13.3%
6/45 • Number of events 9 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
8.7%
2/23 • Number of events 2 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/24 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/42 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/44 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
2.2%
1/45 • Number of events 1 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
8.7%
2/23 • Number of events 2 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/24 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
|
Infections and infestations
Upper respiratory tract infection
|
14.3%
6/42 • Number of events 7 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
15.9%
7/44 • Number of events 8 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
11.1%
5/45 • Number of events 5 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
4.3%
1/23 • Number of events 1 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
12.5%
3/24 • Number of events 6 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
|
Infections and infestations
Urinary tract infection
|
11.9%
5/42 • Number of events 6 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
2.3%
1/44 • Number of events 2 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
6.7%
3/45 • Number of events 4 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
13.0%
3/23 • Number of events 4 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
0.00%
0/24 • 05 December 2022 (first participant screened) to 01 July 2024 (last participant last visit). Median duration of exposure was 24.43 weeks. Adverse event data were collected over the 60-week study period (95.6% of participants completed to Week 60).
Serious treatment-emergent and non-serious treatment-emergent adverse events are summarised for the safety population: all participants who received at least 1 dose of study drug. Safety data were summarised by actual treatment received based on the safety population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place