Trial Outcomes & Findings for Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction - DOSE Finding Study (NCT NCT04270760)
NCT ID: NCT04270760
Last Updated: 2025-05-09
Results Overview
Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
281 participants
Primary outcome timeframe
Baseline and Week 36
Results posted on
2025-05-09
Participant Flow
This study was conducted at 34 centers in Australia, Denmark, Iceland, the Netherlands, Canada, the United States, and Japan between 28 July 2020 and 08 November 2022.
The Treatment Period was 48 weeks with investigational product (IP) administered subcutaneously (SC) every 12 weeks (Q12W) or 24 weeks (Q24W). After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks. Participants remained on standard of care per their local guidelines during the Treatment Period and Extended Safety Follow-up Period.
Participant milestones
| Measure |
Group 1: Olpasiran 10 mg Q12W
Participants were administered SC olpasiran 10 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
|
Group 2: Olpasiran 75 mg Q12W
Participants were administered SC olpasiran 75 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
|
Group 3: Olpasiran 225 mg Q12W
Participants were administered SC olpasiran 225 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
|
Group 4: Olpasiran 225 mg Q24W
Participants were administered SC olpasiran 225 mg Q24W for 48 weeks with doses at Day 1 and Week 24. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
|
Group 5: Placebo Q12W
Participants were administered SC placebo Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
58
|
58
|
56
|
55
|
54
|
|
Overall Study
Entered Extended Safety Follow-up Period
|
57
|
57
|
54
|
55
|
53
|
|
Overall Study
COMPLETED
|
57
|
55
|
52
|
55
|
53
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
4
|
0
|
1
|
Reasons for withdrawal
| Measure |
Group 1: Olpasiran 10 mg Q12W
Participants were administered SC olpasiran 10 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
|
Group 2: Olpasiran 75 mg Q12W
Participants were administered SC olpasiran 75 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
|
Group 3: Olpasiran 225 mg Q12W
Participants were administered SC olpasiran 225 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
|
Group 4: Olpasiran 225 mg Q24W
Participants were administered SC olpasiran 225 mg Q24W for 48 weeks with doses at Day 1 and Week 24. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
|
Group 5: Placebo Q12W
Participants were administered SC placebo Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
3
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
1
|
0
|
0
|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction - DOSE Finding Study
Baseline characteristics by cohort
| Measure |
Group 1: Olpasiran 10 mg Q12W
n=58 Participants
Participants were administered SC olpasiran 10 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
|
Group 2: Olpasiran 75 mg Q12W
n=58 Participants
Participants were administered SC olpasiran 75 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
|
Group 3: Olpasiran 225 mg Q12W
n=56 Participants
Participants were administered SC olpasiran 225 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
|
Group 4: Olpasiran 225 mg Q24W
n=55 Participants
Participants were administered SC olpasiran 225 mg Q24W for 48 weeks with doses at Day 1 and Week 24. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
|
Group 5: Placebo Q12W
n=54 Participants
Participants were administered SC placebo Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
|
Total
n=281 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
63.4 Years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
61.3 Years
STANDARD_DEVIATION 9.2 • n=7 Participants
|
59.7 Years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
61.8 Years
STANDARD_DEVIATION 9.4 • n=4 Participants
|
63.4 Years
STANDARD_DEVIATION 8.9 • n=21 Participants
|
61.9 Years
STANDARD_DEVIATION 9.5 • n=10 Participants
|
|
Age, Customized
18 - 64 years
|
31 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
163 Participants
n=10 Participants
|
|
Age, Customized
65 - 74 years
|
19 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
90 Participants
n=10 Participants
|
|
Age, Customized
75 - 84 years
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
28 Participants
n=10 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
90 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
191 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
56 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
52 Participants
n=21 Participants
|
275 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/Ethnicity, Customized
Asian
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
24 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
White
|
52 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
48 Participants
n=21 Participants
|
248 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 36Population: Participants in the FAS with data available at each time point. FAS: includes all randomized participants who received at least one dose of IP.
Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit.
Outcome measures
| Measure |
Group 1: Olpasiran 10 mg Q12W
n=57 Participants
Participants were administered SC olpasiran 10 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
|
Group 2: Olpasiran 75 mg Q12W
n=57 Participants
Participants were administered SC olpasiran 75 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
|
Group 3: Olpasiran 225 mg Q12W
n=53 Participants
Participants were administered SC olpasiran 225 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
|
Group 4: Olpasiran 225 mg Q24W
n=53 Participants
Participants were administered SC olpasiran 225 mg Q24W for 48 weeks with doses at Day 1 and Week 24. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
|
Group 5: Placebo Q12W
n=51 Participants
Participants were administered SC placebo Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
|
|---|---|---|---|---|---|
|
Percentage Change From Baseline in Lipoprotein(a) (Lp[a]) at Week 36
|
-66.91 Percentage Change in Lp(a)
Standard Error 1.78
|
-93.78 Percentage Change in Lp(a)
Standard Error 1.78
|
-97.53 Percentage Change in Lp(a)
Standard Error 1.82
|
-96.89 Percentage Change in Lp(a)
Standard Error 1.85
|
3.60 Percentage Change in Lp(a)
Standard Error 1.89
|
SECONDARY outcome
Timeframe: Baseline and Week 48Population: Participants in the FAS with data available at each time point. FAS: includes all randomized participants who received at least one dose of IP.
Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit.
Outcome measures
| Measure |
Group 1: Olpasiran 10 mg Q12W
n=57 Participants
Participants were administered SC olpasiran 10 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
|
Group 2: Olpasiran 75 mg Q12W
n=57 Participants
Participants were administered SC olpasiran 75 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
|
Group 3: Olpasiran 225 mg Q12W
n=54 Participants
Participants were administered SC olpasiran 225 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
|
Group 4: Olpasiran 225 mg Q24W
n=53 Participants
Participants were administered SC olpasiran 225 mg Q24W for 48 weeks with doses at Day 1 and Week 24. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
|
Group 5: Placebo Q12W
n=51 Participants
Participants were administered SC placebo Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
|
|---|---|---|---|---|---|
|
Percentage Change From Baseline in Lp(a) at Week 48
|
-64.89 Percentage Change in Lp(a)
Standard Error 2.17
|
-92.54 Percentage Change in Lp(a)
Standard Error 2.17
|
-97.29 Percentage Change in Lp(a)
Standard Error 2.22
|
-82.36 Percentage Change in Lp(a)
Standard Error 2.25
|
3.59 Percentage Change in Lp(a)
Standard Error 2.30
|
SECONDARY outcome
Timeframe: Baseline; Week 36 and Week 48Population: Participants in the FAS with data available at each time point. FAS: includes all randomized participants who received at least one dose of IP.
Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit.
Outcome measures
| Measure |
Group 1: Olpasiran 10 mg Q12W
n=57 Participants
Participants were administered SC olpasiran 10 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
|
Group 2: Olpasiran 75 mg Q12W
n=57 Participants
Participants were administered SC olpasiran 75 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
|
Group 3: Olpasiran 225 mg Q12W
n=54 Participants
Participants were administered SC olpasiran 225 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
|
Group 4: Olpasiran 225 mg Q24W
n=53 Participants
Participants were administered SC olpasiran 225 mg Q24W for 48 weeks with doses at Day 1 and Week 24. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
|
Group 5: Placebo Q12W
n=51 Participants
Participants were administered SC placebo Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
|
|---|---|---|---|---|---|
|
Percentage Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 36 and Week 48
Week 36
|
-17.425 Percentage Change in LDL-C
Standard Error 4.258
|
-16.284 Percentage Change in LDL-C
Standard Error 4.259
|
-16.733 Percentage Change in LDL-C
Standard Error 4.389
|
-18.462 Percentage Change in LDL-C
Standard Error 4.428
|
6.234 Percentage Change in LDL-C
Standard Error 4.520
|
|
Percentage Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 36 and Week 48
Week 48
|
-14.743 Percentage Change in LDL-C
Standard Error 4.419
|
-11.481 Percentage Change in LDL-C
Standard Error 4.418
|
-17.308 Percentage Change in LDL-C
Standard Error 4.532
|
-16.908 Percentage Change in LDL-C
Standard Error 4.608
|
10.113 Percentage Change in LDL-C
Standard Error 4.688
|
SECONDARY outcome
Timeframe: Baseline; Week 36 and Week 48Population: Participants in the FAS with data available at each time point. FAS: includes all randomized participants who received at least one dose of IP.
Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit.
Outcome measures
| Measure |
Group 1: Olpasiran 10 mg Q12W
n=57 Participants
Participants were administered SC olpasiran 10 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
|
Group 2: Olpasiran 75 mg Q12W
n=57 Participants
Participants were administered SC olpasiran 75 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
|
Group 3: Olpasiran 225 mg Q12W
n=54 Participants
Participants were administered SC olpasiran 225 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
|
Group 4: Olpasiran 225 mg Q24W
n=53 Participants
Participants were administered SC olpasiran 225 mg Q24W for 48 weeks with doses at Day 1 and Week 24. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
|
Group 5: Placebo Q12W
n=52 Participants
Participants were administered SC placebo Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
|
|---|---|---|---|---|---|
|
Percentage Change From Baseline in Apolipoprotein (B) (ApoB) at Week 36 and Week 48
Week 36
|
-11.496 Percentage Change in ApoB
Standard Error 2.886
|
-9.302 Percentage Change in ApoB
Standard Error 2.885
|
-10.241 Percentage Change in ApoB
Standard Error 2.960
|
-11.378 Percentage Change in ApoB
Standard Error 3.012
|
7.394 Percentage Change in ApoB
Standard Error 3.066
|
|
Percentage Change From Baseline in Apolipoprotein (B) (ApoB) at Week 36 and Week 48
Week 48
|
-7.748 Percentage Change in ApoB
Standard Error 3.307
|
-4.768 Percentage Change in ApoB
Standard Error 3.305
|
-7.218 Percentage Change in ApoB
Standard Error 3.393
|
-9.548 Percentage Change in ApoB
Standard Error 3.443
|
12.292 Percentage Change in ApoB
Standard Error 3.501
|
SECONDARY outcome
Timeframe: Pre-dose and 1, 3, 6-12, and 24-72 hours post-dose on Day 1 and Week 24; Week 48Population: Participants in the FAS with data available at each time point. FAS: includes all randomized participants who received at least one dose of IP.
Pharmacokinetic blood draws were collected at one timepoint during the 6-12 and 24-72 hour flexible time windows and at Week 48. Lower limit of quantification (LLOQ) = 0.400 ng/mL. Values below the LLOQ were set to zero.
Outcome measures
| Measure |
Group 1: Olpasiran 10 mg Q12W
n=55 Participants
Participants were administered SC olpasiran 10 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
|
Group 2: Olpasiran 75 mg Q12W
n=56 Participants
Participants were administered SC olpasiran 75 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
|
Group 3: Olpasiran 225 mg Q12W
n=49 Participants
Participants were administered SC olpasiran 225 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
|
Group 4: Olpasiran 225 mg Q24W
n=52 Participants
Participants were administered SC olpasiran 225 mg Q24W for 48 weeks with doses at Day 1 and Week 24. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
|
Group 5: Placebo Q12W
Participants were administered SC placebo Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
|
|---|---|---|---|---|---|
|
Mean Serum Olpasiran Concentrations at Day 1, Week 24 and Week 48
Day 1: Pre-dose
|
0.00 ng/mL
Standard Deviation 0.00
|
0.00 ng/mL
Standard Deviation 0.00
|
0.00 ng/mL
Standard Deviation 0.00
|
0.00 ng/mL
Standard Deviation 0.00
|
—
|
|
Mean Serum Olpasiran Concentrations at Day 1, Week 24 and Week 48
Day 1: 1 Hour Post-dose
|
12.3 ng/mL
Standard Deviation 6.9
|
67.1 ng/mL
Standard Deviation 47.4
|
220 ng/mL
Standard Deviation 218
|
275 ng/mL
Standard Deviation 450
|
—
|
|
Mean Serum Olpasiran Concentrations at Day 1, Week 24 and Week 48
Day 1: 3 Hours Post-dose
|
18 ng/mL
Standard Deviation 9.85
|
80.3 ng/mL
Standard Deviation 43.2
|
291 ng/mL
Standard Deviation 273
|
324 ng/mL
Standard Deviation 383
|
—
|
|
Mean Serum Olpasiran Concentrations at Day 1, Week 24 and Week 48
Day 1: 6-12 Hours Post-dose
|
18.6 ng/mL
Standard Deviation 10.1
|
61.7 ng/mL
Standard Deviation 36
|
420 ng/mL
Standard Deviation 432
|
329 ng/mL
Standard Deviation 191
|
—
|
|
Mean Serum Olpasiran Concentrations at Day 1, Week 24 and Week 48
Day 1: 24-72 Hours Post-dose
|
0.995 ng/mL
Standard Deviation 0.946
|
20.4 ng/mL
Standard Deviation 13.2
|
63.2 ng/mL
Standard Deviation 59.7
|
103 ng/mL
Standard Deviation 47.3
|
—
|
|
Mean Serum Olpasiran Concentrations at Day 1, Week 24 and Week 48
Week 24: Pre-dose
|
0.00 ng/mL
Standard Deviation 0.00
|
0.0315 ng/mL
Standard Deviation 0.134
|
0.498 ng/mL
Standard Deviation 1.88
|
0.0645 ng/mL
Standard Deviation 0.22
|
—
|
|
Mean Serum Olpasiran Concentrations at Day 1, Week 24 and Week 48
Week 24: 1 Hour Post-dose
|
12.4 ng/mL
Standard Deviation 7.23
|
73.6 ng/mL
Standard Deviation 43.6
|
204 ng/mL
Standard Deviation 144
|
253 ng/mL
Standard Deviation 247
|
—
|
|
Mean Serum Olpasiran Concentrations at Day 1, Week 24 and Week 48
Week 24: 3 Hours Post-dose
|
16.3 ng/mL
Standard Deviation 9.2
|
96.3 ng/mL
Standard Deviation 63.5
|
278 ng/mL
Standard Deviation 193
|
332 ng/mL
Standard Deviation 255
|
—
|
|
Mean Serum Olpasiran Concentrations at Day 1, Week 24 and Week 48
Week 24: 6-12 Hours Post-dose
|
17.2 ng/mL
Standard Deviation 10.2
|
76.3 ng/mL
Standard Deviation 54.7
|
271 ng/mL
Standard Deviation 229
|
315 ng/mL
Standard Deviation 191
|
—
|
|
Mean Serum Olpasiran Concentrations at Day 1, Week 24 and Week 48
Week 24: 24-72 Hours Post-dose
|
1.27 ng/mL
Standard Deviation 1.82
|
17.3 ng/mL
Standard Deviation 18.9
|
99 ng/mL
Standard Deviation 59.1
|
96.3 ng/mL
Standard Deviation 50.3
|
—
|
|
Mean Serum Olpasiran Concentrations at Day 1, Week 24 and Week 48
Week 48
|
0.00 ng/mL
Standard Deviation 0.00
|
0.0599 ng/mL
Standard Deviation 0.168
|
0.533 ng/mL
Standard Deviation 0.592
|
0.127 ng/mL
Standard Deviation 0.693
|
—
|
Adverse Events
Group 1; Treatment Period: Olpasiran 10 mg Q12W
Serious events: 3 serious events
Other events: 35 other events
Deaths: 0 deaths
Group 2; Treatment Period: Olpasiran 75 mg Q12W
Serious events: 3 serious events
Other events: 40 other events
Deaths: 0 deaths
Group 3; Treatment Period: Olpasiran 225 mg Q12W
Serious events: 6 serious events
Other events: 37 other events
Deaths: 0 deaths
Group 4; Treatment Period: Olpasiran 225 mg Q24W
Serious events: 4 serious events
Other events: 36 other events
Deaths: 0 deaths
Group 5; Treatment Period: Placebo Q12W
Serious events: 8 serious events
Other events: 29 other events
Deaths: 1 deaths
Group 1; Extended Safety Follow-up Period: Olpasiran 10 mg Q12W
Serious events: 4 serious events
Other events: 18 other events
Deaths: 0 deaths
Group 2; Extended Safety Follow-up Period: Olpasiran 75 mg Q12W
Serious events: 2 serious events
Other events: 25 other events
Deaths: 0 deaths
Group 3; Extended Safety Follow-up Period: Olpasiran 225 mg Q12W
Serious events: 6 serious events
Other events: 21 other events
Deaths: 0 deaths
Group 4; Extended Safety Follow-up Period: Olpasiran 225 mg Q24W
Serious events: 5 serious events
Other events: 17 other events
Deaths: 0 deaths
Group 5; Extended Safety Follow-up: Placebo Q12W
Serious events: 4 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1; Treatment Period: Olpasiran 10 mg Q12W
n=58 participants at risk
Participants were administered SC olpasiran 10 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36.
|
Group 2; Treatment Period: Olpasiran 75 mg Q12W
n=58 participants at risk
Participants were administered SC olpasiran 75 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36.
|
Group 3; Treatment Period: Olpasiran 225 mg Q12W
n=56 participants at risk
Participants were administered SC olpasiran 225 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36.
|
Group 4; Treatment Period: Olpasiran 225 mg Q24W
n=55 participants at risk
Participants were administered SC olpasiran 225 mg Q24W for 48 weeks with doses at Day 1 and Week 24.
|
Group 5; Treatment Period: Placebo Q12W
n=54 participants at risk
Participants were administered SC placebo Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36.
|
Group 1; Extended Safety Follow-up Period: Olpasiran 10 mg Q12W
n=57 participants at risk
After Week 48 there was an extended safety follow-up without further dosing with IP for a minimum of 24 weeks.
|
Group 2; Extended Safety Follow-up Period: Olpasiran 75 mg Q12W
n=57 participants at risk
After Week 48 there was an extended safety follow-up without further dosing with IP for a minimum of 24 weeks.
|
Group 3; Extended Safety Follow-up Period: Olpasiran 225 mg Q12W
n=54 participants at risk
After Week 48 there was an extended safety follow-up without further dosing with IP for a minimum of 24 weeks.
|
Group 4; Extended Safety Follow-up Period: Olpasiran 225 mg Q24W
n=55 participants at risk
After Week 48 there was an extended safety follow-up without further dosing with IP for a minimum of 24 weeks.
|
Group 5; Extended Safety Follow-up: Placebo Q12W
n=53 participants at risk
After Week 48 there was an extended safety follow-up without further dosing with IP for a minimum of 24 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
1.7%
1/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Eye disorders
Cataract
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.9%
1/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Cardiac disorders
Angina unstable
|
1.7%
1/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.9%
1/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.9%
1/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
General disorders
Injection site reaction
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
General disorders
Injection site urticaria
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.9%
1/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.9%
1/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.7%
1/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Infections and infestations
Campylobacter infection
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Infections and infestations
Diverticulitis intestinal perforated
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Infections and infestations
Influenza
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.9%
1/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.9%
1/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Infections and infestations
Urinary tract infection
|
1.7%
1/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Infections and infestations
Vestibular neuronitis
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Injury, poisoning and procedural complications
Fall
|
1.7%
1/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.7%
1/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.7%
1/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
1.7%
1/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.9%
1/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.7%
1/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
3.7%
2/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage IV
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.9%
1/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal cancer metastatic
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.9%
1/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal carcinoma
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.9%
1/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma stage I
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to pancreas
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.9%
1/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer recurrent
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.9%
1/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.9%
1/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.9%
1/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Nervous system disorders
Seizure
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Nervous system disorders
Syncope
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Product Issues
Device inappropriate shock delivery
|
1.7%
1/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Psychiatric disorders
Depression
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.9%
1/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.7%
1/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Renal and urinary disorders
Urinoma
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.7%
1/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.9%
1/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Vascular disorders
Hypertension
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.9%
1/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Vascular disorders
Iliac artery occlusion
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
Other adverse events
| Measure |
Group 1; Treatment Period: Olpasiran 10 mg Q12W
n=58 participants at risk
Participants were administered SC olpasiran 10 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36.
|
Group 2; Treatment Period: Olpasiran 75 mg Q12W
n=58 participants at risk
Participants were administered SC olpasiran 75 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36.
|
Group 3; Treatment Period: Olpasiran 225 mg Q12W
n=56 participants at risk
Participants were administered SC olpasiran 225 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36.
|
Group 4; Treatment Period: Olpasiran 225 mg Q24W
n=55 participants at risk
Participants were administered SC olpasiran 225 mg Q24W for 48 weeks with doses at Day 1 and Week 24.
|
Group 5; Treatment Period: Placebo Q12W
n=54 participants at risk
Participants were administered SC placebo Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36.
|
Group 1; Extended Safety Follow-up Period: Olpasiran 10 mg Q12W
n=57 participants at risk
After Week 48 there was an extended safety follow-up without further dosing with IP for a minimum of 24 weeks.
|
Group 2; Extended Safety Follow-up Period: Olpasiran 75 mg Q12W
n=57 participants at risk
After Week 48 there was an extended safety follow-up without further dosing with IP for a minimum of 24 weeks.
|
Group 3; Extended Safety Follow-up Period: Olpasiran 225 mg Q12W
n=54 participants at risk
After Week 48 there was an extended safety follow-up without further dosing with IP for a minimum of 24 weeks.
|
Group 4; Extended Safety Follow-up Period: Olpasiran 225 mg Q24W
n=55 participants at risk
After Week 48 there was an extended safety follow-up without further dosing with IP for a minimum of 24 weeks.
|
Group 5; Extended Safety Follow-up: Placebo Q12W
n=53 participants at risk
After Week 48 there was an extended safety follow-up without further dosing with IP for a minimum of 24 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.2%
3/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.7%
1/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
3.5%
2/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.9%
1/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.9%
1/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
5.4%
3/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
3.6%
2/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
3.7%
2/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Gastrointestinal disorders
Constipation
|
5.2%
3/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
3.6%
2/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
3.7%
2/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.4%
2/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
5.2%
3/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
5.4%
3/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
7.4%
4/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.7%
1/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.7%
1/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
3.7%
2/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.9%
1/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
5.7%
3/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Gastrointestinal disorders
Nausea
|
3.4%
2/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.7%
1/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
3.6%
2/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
5.5%
3/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.9%
1/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
3.6%
2/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.9%
1/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
General disorders
Fatigue
|
10.3%
6/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
13.8%
8/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
5.4%
3/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
3.6%
2/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
5.6%
3/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
3.5%
2/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.9%
1/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
General disorders
Injection site bruising
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
6.9%
4/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
8.9%
5/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
7.4%
4/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
General disorders
Injection site erythema
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
5.2%
3/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
5.4%
3/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
7.3%
4/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
General disorders
Injection site pain
|
3.4%
2/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
5.2%
3/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
9.1%
5/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
3.7%
2/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
General disorders
Injection site pruritus
|
1.7%
1/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
5.5%
3/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
General disorders
Non-cardiac chest pain
|
3.4%
2/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
3.4%
2/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
7.3%
4/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.9%
1/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
3.5%
2/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
General disorders
Oedema peripheral
|
3.4%
2/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.7%
1/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
5.5%
3/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
3.7%
2/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Immune system disorders
Immunisation reaction
|
13.8%
8/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
6.9%
4/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
3.6%
2/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
7.3%
4/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
9.3%
5/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
3.7%
2/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Infections and infestations
COVID-19
|
1.7%
1/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
13.8%
8/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
12.5%
7/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
7.3%
4/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
11.1%
6/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
14.0%
8/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
19.3%
11/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
25.9%
14/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
18.2%
10/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
18.9%
10/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Infections and infestations
Gastroenteritis
|
1.7%
1/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
6.9%
4/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
3.6%
2/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.9%
1/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.9%
1/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.9%
1/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Infections and infestations
Nasopharyngitis
|
3.4%
2/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
3.4%
2/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
7.1%
4/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.9%
1/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
5.3%
3/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
3.6%
2/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
5.2%
3/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
3.6%
2/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.9%
4/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
5.2%
3/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
3.6%
2/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
3.7%
2/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
3.5%
2/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
3.5%
2/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.9%
1/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Infections and infestations
Urinary tract infection
|
5.2%
3/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
6.9%
4/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
3.6%
2/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.9%
1/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
7.0%
4/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.9%
1/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.7%
1/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
5.6%
3/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
3.5%
2/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Injury, poisoning and procedural complications
Fall
|
3.4%
2/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
5.2%
3/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.9%
1/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
3.6%
2/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
5.2%
3/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
5.2%
3/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
3.6%
2/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
3.7%
2/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.4%
2/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
5.2%
3/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
5.4%
3/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
3.6%
2/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.9%
1/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.9%
1/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.9%
1/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.3%
6/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
8.6%
5/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
12.5%
7/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
5.6%
3/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
5.3%
3/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.9%
1/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.2%
3/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.7%
1/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
7.1%
4/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
7.3%
4/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
7.4%
4/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
3.5%
2/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.4%
2/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.7%
1/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
5.5%
3/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.9%
1/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Nervous system disorders
Areflexia
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
5.2%
3/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.9%
1/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
5.2%
3/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
3.6%
2/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
3.7%
2/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.9%
1/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Nervous system disorders
Headache
|
10.3%
6/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
12.1%
7/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
10.7%
6/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
10.9%
6/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
7.4%
4/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
3.7%
2/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.2%
3/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.7%
1/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.9%
1/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
5.7%
3/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
|
Vascular disorders
Hypertension
|
6.9%
4/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
3.4%
2/58 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
5.4%
3/56 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
3.6%
2/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
3.7%
2/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.8%
1/57 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/54 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
0.00%
0/55 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
1.9%
1/53 • Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment received.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER