Trial Outcomes & Findings for Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of AMG 890 in Subjects With Elevated Plasma Lipoprotein(a) (NCT NCT03626662)
NCT ID: NCT03626662
Last Updated: 2026-01-28
Results Overview
An adverse event was defined as any untoward medical occurrence in a clinical trial participant. A TEAE was defined as any event with onset after the administration of the first dose of investigational product and up to and including the end of treatment date, or end of trial for participants who discontinued the trial during the treatment period. Clinically significant changes in vital signs, electrocardiograms (ECGs), and safety laboratory analytes were included as TEAEs.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
79 participants
Primary outcome timeframe
From first dose of trial until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months
Results posted on
2026-01-28
Participant Flow
Participants were enrolled at 8 research centers in the United States (US) and Australia between July 2018 and April 2023.
Participants were randomized in a 3:1 ratio to receive either Olpasiran or a volume-matched placebo via subcutaneous (SC) injection, across 9 single ascending dose cohorts.
Participant milestones
| Measure |
Placebo
Participants with screening plasma Lipoprotein(a) (Lp\[a\]) \>=70 nmol/L and \<199 nmol/L received placebo matching Olpasiran as a single SC injection on Day 1 in cohorts 1-5. Participants with screening plasma Lp(a) \>=200 nmol/L received placebo matching Olpasiran as a single SC injection on Day 1 in cohorts 6-9.
|
Cohort 1: Olpasiran 3 mg
Participants with screening plasma Lp(a) \>=70 nmol/L and \<199 nmol/L received Olpasiran 3 mg as a single SC injection on Day 1.
|
Cohort 2: Olpasiran 9 mg
Participants with screening plasma Lp(a) \>=70 nmol/L and \<199 nmol/L received Olpasiran 9 mg as a single SC injection on Day 1.
|
Cohort 3: Olpasiran 30 mg
Participants with screening plasma Lp(a) \>=70 nmol/L and \<199 nmol/L received Olpasiran 30 mg as a single SC injection on Day 1.
|
Cohort 4 Olpasiran: 75 mg
Participants with screening plasma Lp(a) \>=70 nmol/L and \<199 nmol/L received Olpasiran 75 mg as a single SC injection on Day 1.
|
Cohort 5 Olpasiran: 225 mg
Participants with screening plasma Lp(a) \>=70 nmol/L and \<199 nmol/L received Olpasiran 225 mg as a single SC injection on Day 1.
|
Cohort 6: Olpasiran 9 mg
Participants with screening plasma Lp(a) \>= 200 nmol/L received Olpasiran 9 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment.
|
Cohort 7: Olpasiran 75 mg
Participants with screening plasma Lp(a) \>= 200 nmol/L received Olpasiran 75 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment.
|
Cohort 8: Olpasiran 225 mg
Participants with screening plasma Lp(a) \>= 200 nmol/L received Olpasiran 225 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment.
|
Cohort 9: Olpasiran 675 mg
Participants with screening plasma Lp(a) \>= 200 nmol/L received Olpasiran 675 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
6
|
6
|
6
|
6
|
6
|
9
|
9
|
5
|
6
|
|
Overall Study
Participants Who Received Placebo in Cohorts 1-5
|
10
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Participants Who Received Placebo in Cohorts 6-9
|
10
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
17
|
6
|
4
|
6
|
2
|
3
|
8
|
6
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
2
|
0
|
4
|
3
|
1
|
3
|
0
|
1
|
Reasons for withdrawal
| Measure |
Placebo
Participants with screening plasma Lipoprotein(a) (Lp\[a\]) \>=70 nmol/L and \<199 nmol/L received placebo matching Olpasiran as a single SC injection on Day 1 in cohorts 1-5. Participants with screening plasma Lp(a) \>=200 nmol/L received placebo matching Olpasiran as a single SC injection on Day 1 in cohorts 6-9.
|
Cohort 1: Olpasiran 3 mg
Participants with screening plasma Lp(a) \>=70 nmol/L and \<199 nmol/L received Olpasiran 3 mg as a single SC injection on Day 1.
|
Cohort 2: Olpasiran 9 mg
Participants with screening plasma Lp(a) \>=70 nmol/L and \<199 nmol/L received Olpasiran 9 mg as a single SC injection on Day 1.
|
Cohort 3: Olpasiran 30 mg
Participants with screening plasma Lp(a) \>=70 nmol/L and \<199 nmol/L received Olpasiran 30 mg as a single SC injection on Day 1.
|
Cohort 4 Olpasiran: 75 mg
Participants with screening plasma Lp(a) \>=70 nmol/L and \<199 nmol/L received Olpasiran 75 mg as a single SC injection on Day 1.
|
Cohort 5 Olpasiran: 225 mg
Participants with screening plasma Lp(a) \>=70 nmol/L and \<199 nmol/L received Olpasiran 225 mg as a single SC injection on Day 1.
|
Cohort 6: Olpasiran 9 mg
Participants with screening plasma Lp(a) \>= 200 nmol/L received Olpasiran 9 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment.
|
Cohort 7: Olpasiran 75 mg
Participants with screening plasma Lp(a) \>= 200 nmol/L received Olpasiran 75 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment.
|
Cohort 8: Olpasiran 225 mg
Participants with screening plasma Lp(a) \>= 200 nmol/L received Olpasiran 225 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment.
|
Cohort 9: Olpasiran 675 mg
Participants with screening plasma Lp(a) \>= 200 nmol/L received Olpasiran 675 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal of Consent from Study
|
2
|
0
|
0
|
0
|
4
|
3
|
0
|
0
|
0
|
1
|
|
Overall Study
Decision by Sponsor
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
3
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of AMG 890 in Subjects With Elevated Plasma Lipoprotein(a)
Baseline characteristics by cohort
| Measure |
Placebo
n=20 Participants
Participants with screening plasma Lp(a) \>=70 nmol/L and \<199 nmol/L received placebo matching Olpasiran as a single SC injection on Day 1 in cohorts 1-5. Participants with screening plasma Lp(a) \>=200 nmol/L received placebo matching Olpasiran as a single SC injection on Day 1 in cohorts 6-9.
|
Cohort 1: Olpasiran 3 mg
n=6 Participants
Participants with screening plasma Lp(a) \>=70 nmol/L and \<199 nmol/L received Olpasiran 3 mg as a single SC injection on Day 1.
|
Cohort 2: Olpasiran 9 mg
n=6 Participants
Participants with screening plasma Lp(a) \>=70 nmol/L and \<199 nmol/L received Olpasiran 9 mg as a single SC injection on Day 1.
|
Cohort 3: Olpasiran 30 mg
n=6 Participants
Participants with screening plasma Lp(a) \>=70 nmol/L and \<199 nmol/L received Olpasiran 30 mg as a single SC injection on Day 1.
|
Cohort 4 Olpasiran: 75 mg
n=6 Participants
Participants with screening plasma Lp(a) \>=70 nmol/L and \<199 nmol/L received Olpasiran 75 mg as a single SC injection on Day 1.
|
Cohort 5 Olpasiran: 225 mg
n=6 Participants
Participants with screening plasma Lp(a) \>=70 nmol/L and \<199 nmol/L received Olpasiran 225 mg as a single SC injection on Day 1.
|
Cohort 6: Olpasiran 9 mg
n=9 Participants
Participants with screening plasma Lp(a) \>= 200 nmol/L received Olpasiran 9 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment.
|
Cohort 7: Olpasiran 75 mg
n=9 Participants
Participants with screening plasma Lp(a) \>= 200 nmol/L received Olpasiran 75 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment.
|
Cohort 8: Olpasiran 225 mg
n=5 Participants
Participants with screening plasma Lp(a) \>= 200 nmol/L received Olpasiran 225 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment.
|
Cohort 9: Olpasiran 675 mg
n=6 Participants
Participants with screening plasma Lp(a) \>= 200 nmol/L received Olpasiran 675 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment.
|
Total
n=79 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=158 Participants
|
6 Participants
n=157 Participants
|
6 Participants
n=315 Participants
|
4 Participants
n=153 Participants
|
1 Participants
n=11 Participants
|
2 Participants
n=12 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=528 Participants
|
32 Participants
n=590 Participants
|
|
Age, Continuous
|
52.0 years
STANDARD_DEVIATION 8.8 • n=158 Participants
|
42.7 years
STANDARD_DEVIATION 16.0 • n=157 Participants
|
50.2 years
STANDARD_DEVIATION 7.6 • n=315 Participants
|
34.5 years
STANDARD_DEVIATION 11.5 • n=153 Participants
|
51.5 years
STANDARD_DEVIATION 13.4 • n=11 Participants
|
40.8 years
STANDARD_DEVIATION 14.3 • n=12 Participants
|
52.7 years
STANDARD_DEVIATION 10.8 • n=4 Participants
|
52.8 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
58.2 years
STANDARD_DEVIATION 4.3 • n=4 Participants
|
47.7 years
STANDARD_DEVIATION 13.1 • n=528 Participants
|
49.2 years
STANDARD_DEVIATION 11.8 • n=590 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=158 Participants
|
3 Participants
n=157 Participants
|
2 Participants
n=315 Participants
|
1 Participants
n=153 Participants
|
3 Participants
n=11 Participants
|
0 Participants
n=12 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=528 Participants
|
29 Participants
n=590 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=158 Participants
|
3 Participants
n=157 Participants
|
4 Participants
n=315 Participants
|
5 Participants
n=153 Participants
|
3 Participants
n=11 Participants
|
6 Participants
n=12 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=528 Participants
|
50 Participants
n=590 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
2 Participants
n=153 Participants
|
5 Participants
n=11 Participants
|
4 Participants
n=12 Participants
|
7 Participants
n=4 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=528 Participants
|
47 Participants
n=590 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
0 Participants
n=153 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=528 Participants
|
0 Participants
n=590 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
0 Participants
n=153 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=528 Participants
|
1 Participants
n=590 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
0 Participants
n=153 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=528 Participants
|
0 Participants
n=590 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
0 Participants
n=153 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=528 Participants
|
0 Participants
n=590 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=158 Participants
|
4 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
1 Participants
n=153 Participants
|
3 Participants
n=11 Participants
|
1 Participants
n=12 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=528 Participants
|
14 Participants
n=590 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=158 Participants
|
2 Participants
n=157 Participants
|
6 Participants
n=315 Participants
|
5 Participants
n=153 Participants
|
3 Participants
n=11 Participants
|
5 Participants
n=12 Participants
|
7 Participants
n=4 Participants
|
9 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=528 Participants
|
63 Participants
n=590 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
0 Participants
n=153 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=528 Participants
|
0 Participants
n=590 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
0 Participants
n=153 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=528 Participants
|
1 Participants
n=590 Participants
|
PRIMARY outcome
Timeframe: From first dose of trial until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) monthsPopulation: The safety analysis set consisted of all participants who received at least 1 dose of Olpasiran or placebo.
An adverse event was defined as any untoward medical occurrence in a clinical trial participant. A TEAE was defined as any event with onset after the administration of the first dose of investigational product and up to and including the end of treatment date, or end of trial for participants who discontinued the trial during the treatment period. Clinically significant changes in vital signs, electrocardiograms (ECGs), and safety laboratory analytes were included as TEAEs.
Outcome measures
| Measure |
Cohorts 1-5: Placebo
n=10 Participants
Participants with screening plasma Lp(a) \>=70 nmol/L and \<199 nmol/L received placebo matching Olpasiran as a single SC injection on Day 1 in cohorts 1 -5.
|
Cohort 1: Olpasiran 3 mg
n=6 Participants
Participants with screening plasma Lp(a) \>=70 nmol/L and \<199 nmol/L received Olpasiran 3 mg as a single SC injection on Day 1.
|
Cohort 2: Olpasiran 9 mg
n=6 Participants
Participants with screening plasma Lp(a) \>=70 nmol/L and \<199 nmol/L received Olpasiran 9 mg as a single SC injection on Day 1.
|
Cohort 3: Olpasiran 30 mg
n=6 Participants
Participants with screening plasma Lp(a) \>=70 nmol/L and \<199 nmol/L received Olpasiran 30 mg as a single SC injection on Day 1.
|
Cohort 4 Olpasiran: 75 mg
n=6 Participants
Participants with screening plasma Lp(a) \>=70 nmol/L and \<199 nmol/L received Olpasiran 75 mg as a single SC injection on Day 1.
|
Cohort 5 Olpasiran: 225 mg
n=6 Participants
Participants with screening plasma Lp(a) \>=70 nmol/L and \<199 nmol/L received Olpasiran 225 mg as a single SC injection on Day 1.
|
Cohorts 6-9: Placebo
n=10 Participants
Participants with screening plasma Lp(a) \>=200 nmol/L received placebo matching Olpasiran as a single SC injection on Day 1 in cohorts 6-9.
|
Cohort 6: Olpasiran 9 mg
n=9 Participants
Participants with screening plasma Lp(a) \>= 200 nmol/L received Olpasiran 9 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment.
|
Cohort 7: Olpasiran 75 mg
n=9 Participants
Participants with screening plasma Lp(a) \>= 200 nmol/L received Olpasiran 75 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment.
|
Cohort 8: Olpasiran 225 mg
n=5 Participants
Participants with screening plasma Lp(a) \>= 200 nmol/L received Olpasiran 225 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment.
|
Cohort 9: Olpasiran 675 mg
n=6 Participants
Participants with screening plasma Lp(a) \>= 200 nmol/L received Olpasiran 675 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
|
5 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
1 Participants
|
0 Participants
|
7 Participants
|
6 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Cohorts 1-5:pre-dose, Days 1-4, 7, 15, 29, 57, 85 post-dose; Cohorts 6-7:pre-dose, Days 1, 2, 4, 7, 15 post-dose; Cohort 8:pre-dose, Days 1, 2, 4, 7, 15, 29, 57, 85, 113 post-dose; Cohort 9:pre-dose, Days 1, 2, 4, 7, 15, 29, 57, 85, 113, 155 post-dosePopulation: The pharmacokinetic (PK) analysis set consisted of all Olpasiran dosed participants for whom at least one PK parameter was reliably estimated.
Blood samples were collected for measurement of serum concentrations of Olpasiran.
Outcome measures
| Measure |
Cohorts 1-5: Placebo
n=6 Participants
Participants with screening plasma Lp(a) \>=70 nmol/L and \<199 nmol/L received placebo matching Olpasiran as a single SC injection on Day 1 in cohorts 1 -5.
|
Cohort 1: Olpasiran 3 mg
n=6 Participants
Participants with screening plasma Lp(a) \>=70 nmol/L and \<199 nmol/L received Olpasiran 3 mg as a single SC injection on Day 1.
|
Cohort 2: Olpasiran 9 mg
n=6 Participants
Participants with screening plasma Lp(a) \>=70 nmol/L and \<199 nmol/L received Olpasiran 9 mg as a single SC injection on Day 1.
|
Cohort 3: Olpasiran 30 mg
n=6 Participants
Participants with screening plasma Lp(a) \>=70 nmol/L and \<199 nmol/L received Olpasiran 30 mg as a single SC injection on Day 1.
|
Cohort 4 Olpasiran: 75 mg
n=6 Participants
Participants with screening plasma Lp(a) \>=70 nmol/L and \<199 nmol/L received Olpasiran 75 mg as a single SC injection on Day 1.
|
Cohort 5 Olpasiran: 225 mg
n=9 Participants
Participants with screening plasma Lp(a) \>=70 nmol/L and \<199 nmol/L received Olpasiran 225 mg as a single SC injection on Day 1.
|
Cohorts 6-9: Placebo
n=9 Participants
Participants with screening plasma Lp(a) \>=200 nmol/L received placebo matching Olpasiran as a single SC injection on Day 1 in cohorts 6-9.
|
Cohort 6: Olpasiran 9 mg
n=5 Participants
Participants with screening plasma Lp(a) \>= 200 nmol/L received Olpasiran 9 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment.
|
Cohort 7: Olpasiran 75 mg
n=6 Participants
Participants with screening plasma Lp(a) \>= 200 nmol/L received Olpasiran 75 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment.
|
Cohort 8: Olpasiran 225 mg
Participants with screening plasma Lp(a) \>= 200 nmol/L received Olpasiran 225 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment.
|
Cohort 9: Olpasiran 675 mg
Participants with screening plasma Lp(a) \>= 200 nmol/L received Olpasiran 675 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Concentration (Cmax) of Olpasiran
|
11.7 ng/mL
Standard Deviation 2.36
|
36.1 ng/mL
Standard Deviation 19.7
|
74.9 ng/mL
Standard Deviation 25
|
252 ng/mL
Standard Deviation 153
|
421 ng/mL
Standard Deviation 223
|
17.4 ng/mL
Standard Deviation 7.48
|
111 ng/mL
Standard Deviation 56.3
|
1390 ng/mL
Standard Deviation 947
|
2620 ng/mL
Standard Deviation 888
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohorts 1-5:pre-dose, Days 1-4, 7, 15, 29, 57, 85 post-dose; Cohorts 6-7:pre-dose, Days 1, 2, 4, 7, 15 post-dose; Cohort 8:pre-dose, Days 1, 2, 4, 7, 15, 29, 57, 85, 113 post-dose; Cohort 9:pre-dose, Days 1, 2, 4, 7, 15, 29, 57, 85, 113, 155 post-dosePopulation: The PK analysis set consisted of all Olpasiran dosed participants for whom at least one PK parameter was reliably estimated.
Blood samples were collected for measurement of serum concentrations of Olpasiran.
Outcome measures
| Measure |
Cohorts 1-5: Placebo
n=6 Participants
Participants with screening plasma Lp(a) \>=70 nmol/L and \<199 nmol/L received placebo matching Olpasiran as a single SC injection on Day 1 in cohorts 1 -5.
|
Cohort 1: Olpasiran 3 mg
n=6 Participants
Participants with screening plasma Lp(a) \>=70 nmol/L and \<199 nmol/L received Olpasiran 3 mg as a single SC injection on Day 1.
|
Cohort 2: Olpasiran 9 mg
n=6 Participants
Participants with screening plasma Lp(a) \>=70 nmol/L and \<199 nmol/L received Olpasiran 9 mg as a single SC injection on Day 1.
|
Cohort 3: Olpasiran 30 mg
n=6 Participants
Participants with screening plasma Lp(a) \>=70 nmol/L and \<199 nmol/L received Olpasiran 30 mg as a single SC injection on Day 1.
|
Cohort 4 Olpasiran: 75 mg
n=6 Participants
Participants with screening plasma Lp(a) \>=70 nmol/L and \<199 nmol/L received Olpasiran 75 mg as a single SC injection on Day 1.
|
Cohort 5 Olpasiran: 225 mg
n=9 Participants
Participants with screening plasma Lp(a) \>=70 nmol/L and \<199 nmol/L received Olpasiran 225 mg as a single SC injection on Day 1.
|
Cohorts 6-9: Placebo
n=9 Participants
Participants with screening plasma Lp(a) \>=200 nmol/L received placebo matching Olpasiran as a single SC injection on Day 1 in cohorts 6-9.
|
Cohort 6: Olpasiran 9 mg
n=5 Participants
Participants with screening plasma Lp(a) \>= 200 nmol/L received Olpasiran 9 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment.
|
Cohort 7: Olpasiran 75 mg
n=6 Participants
Participants with screening plasma Lp(a) \>= 200 nmol/L received Olpasiran 75 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment.
|
Cohort 8: Olpasiran 225 mg
Participants with screening plasma Lp(a) \>= 200 nmol/L received Olpasiran 225 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment.
|
Cohort 9: Olpasiran 675 mg
Participants with screening plasma Lp(a) \>= 200 nmol/L received Olpasiran 675 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Reach Cmax (Tmax) of Olpasiran
|
3.0 hours
Interval 1.0 to 9.0
|
3.0 hours
Interval 3.0 to 6.0
|
7.5 hours
Interval 1.0 to 9.0
|
4.5 hours
Interval 0.17 to 9.0
|
6.0 hours
Interval 1.0 to 12.0
|
3.0 hours
Interval 1.0 to 9.0
|
6.0 hours
Interval 3.0 to 24.0
|
3.0 hours
Interval 1.0 to 23.0
|
4.5 hours
Interval 2.1 to 6.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohorts 1-5:pre-dose, Days 1-4, 7, 15, 29, 57, 85 post-dose; Cohorts 6-7:pre-dose, Days 1, 2, 4, 7, 15 post-dose; Cohort 8:pre-dose, Days 1, 2, 4, 7, 15, 29, 57, 85, 113 post-dose; Cohort 9:pre-dose, Days 1, 2, 4, 7, 15, 29, 57, 85, 113, 155 post-dosePopulation: The PK analysis set consisted of all Olpasiran dosed participants for whom at least one PK parameter was reliably estimated.
Blood samples were collected for measurement of serum concentrations of Olpasiran.
Outcome measures
| Measure |
Cohorts 1-5: Placebo
n=6 Participants
Participants with screening plasma Lp(a) \>=70 nmol/L and \<199 nmol/L received placebo matching Olpasiran as a single SC injection on Day 1 in cohorts 1 -5.
|
Cohort 1: Olpasiran 3 mg
n=6 Participants
Participants with screening plasma Lp(a) \>=70 nmol/L and \<199 nmol/L received Olpasiran 3 mg as a single SC injection on Day 1.
|
Cohort 2: Olpasiran 9 mg
n=6 Participants
Participants with screening plasma Lp(a) \>=70 nmol/L and \<199 nmol/L received Olpasiran 9 mg as a single SC injection on Day 1.
|
Cohort 3: Olpasiran 30 mg
n=6 Participants
Participants with screening plasma Lp(a) \>=70 nmol/L and \<199 nmol/L received Olpasiran 30 mg as a single SC injection on Day 1.
|
Cohort 4 Olpasiran: 75 mg
n=6 Participants
Participants with screening plasma Lp(a) \>=70 nmol/L and \<199 nmol/L received Olpasiran 75 mg as a single SC injection on Day 1.
|
Cohort 5 Olpasiran: 225 mg
n=9 Participants
Participants with screening plasma Lp(a) \>=70 nmol/L and \<199 nmol/L received Olpasiran 225 mg as a single SC injection on Day 1.
|
Cohorts 6-9: Placebo
n=9 Participants
Participants with screening plasma Lp(a) \>=200 nmol/L received placebo matching Olpasiran as a single SC injection on Day 1 in cohorts 6-9.
|
Cohort 6: Olpasiran 9 mg
n=5 Participants
Participants with screening plasma Lp(a) \>= 200 nmol/L received Olpasiran 9 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment.
|
Cohort 7: Olpasiran 75 mg
n=6 Participants
Participants with screening plasma Lp(a) \>= 200 nmol/L received Olpasiran 75 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment.
|
Cohort 8: Olpasiran 225 mg
Participants with screening plasma Lp(a) \>= 200 nmol/L received Olpasiran 225 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment.
|
Cohort 9: Olpasiran 675 mg
Participants with screening plasma Lp(a) \>= 200 nmol/L received Olpasiran 675 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve (AUC) From Time Zero to the Last Quantifiable Timepoint (AUC0-last) of Olpasiran
|
116 hour*ng/mL
Standard Deviation 39.8
|
352 hour*ng/mL
Standard Deviation 141
|
1020 hour*ng/mL
Standard Deviation 329
|
2830 hour*ng/mL
Standard Deviation 730
|
7800 hour*ng/mL
Standard Deviation 1670
|
240 hour*ng/mL
Standard Deviation 96.3
|
2060 hour*ng/mL
Standard Deviation 642
|
29600 hour*ng/mL
Standard Deviation 23500
|
44800 hour*ng/mL
Standard Deviation 16400
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohorts 1-2:Baseline,Days 2,4,7,15,18,22,29,43,57,71,85,113;3-5:Baseline,Days 2,4,7,15,18,22,29,43,57,71,85,113,155,183,225;6-7:Baseline,Days 2,4,7,15,29,43,57,85,113,155,183,225;8-9:Baseline,Days 2,4,7,15,29,43,57,85,113,155,183,225,253,281,309,337,365Population: The pharmacodynamic (PD) analysis set consisted of all dosed participants for whom at least one PD parameter had a baseline value and at least 1 post-baseline measurement available. Participants with data available at each timepoint are presented.
Change from baseline for plasma Lp(a) by cohort and at scheduled time points were presented.
Outcome measures
| Measure |
Cohorts 1-5: Placebo
n=10 Participants
Participants with screening plasma Lp(a) \>=70 nmol/L and \<199 nmol/L received placebo matching Olpasiran as a single SC injection on Day 1 in cohorts 1 -5.
|
Cohort 1: Olpasiran 3 mg
n=6 Participants
Participants with screening plasma Lp(a) \>=70 nmol/L and \<199 nmol/L received Olpasiran 3 mg as a single SC injection on Day 1.
|
Cohort 2: Olpasiran 9 mg
n=6 Participants
Participants with screening plasma Lp(a) \>=70 nmol/L and \<199 nmol/L received Olpasiran 9 mg as a single SC injection on Day 1.
|
Cohort 3: Olpasiran 30 mg
n=6 Participants
Participants with screening plasma Lp(a) \>=70 nmol/L and \<199 nmol/L received Olpasiran 30 mg as a single SC injection on Day 1.
|
Cohort 4 Olpasiran: 75 mg
n=6 Participants
Participants with screening plasma Lp(a) \>=70 nmol/L and \<199 nmol/L received Olpasiran 75 mg as a single SC injection on Day 1.
|
Cohort 5 Olpasiran: 225 mg
n=6 Participants
Participants with screening plasma Lp(a) \>=70 nmol/L and \<199 nmol/L received Olpasiran 225 mg as a single SC injection on Day 1.
|
Cohorts 6-9: Placebo
n=10 Participants
Participants with screening plasma Lp(a) \>=200 nmol/L received placebo matching Olpasiran as a single SC injection on Day 1 in cohorts 6-9.
|
Cohort 6: Olpasiran 9 mg
n=9 Participants
Participants with screening plasma Lp(a) \>= 200 nmol/L received Olpasiran 9 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment.
|
Cohort 7: Olpasiran 75 mg
n=9 Participants
Participants with screening plasma Lp(a) \>= 200 nmol/L received Olpasiran 75 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment.
|
Cohort 8: Olpasiran 225 mg
n=5 Participants
Participants with screening plasma Lp(a) \>= 200 nmol/L received Olpasiran 225 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment.
|
Cohort 9: Olpasiran 675 mg
n=6 Participants
Participants with screening plasma Lp(a) \>= 200 nmol/L received Olpasiran 675 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Plasma Lp(a) Levels
Change from baseline to Day 43
|
-7.720 nmol/L
Standard Deviation 14.629
|
-89.787 nmol/L
Standard Deviation 25.866
|
-108.734 nmol/L
Standard Deviation 28.948
|
-90.072 nmol/L
Standard Deviation 20.412
|
-129.230 nmol/L
Standard Deviation 25.491
|
-140.572 nmol/L
Standard Deviation 36.947
|
-33.244 nmol/L
Standard Deviation 64.989
|
-197.673 nmol/L
Standard Deviation 36.630
|
-282.841 nmol/L
Standard Deviation 95.711
|
-257.585 nmol/L
Standard Deviation 30.464
|
-351.707 nmol/L
Standard Deviation 193.404
|
|
Change From Baseline in Plasma Lp(a) Levels
Change from baseline to Day 57
|
2.620 nmol/L
Standard Deviation 11.739
|
-87.220 nmol/L
Standard Deviation 29.478
|
-106.834 nmol/L
Standard Deviation 27.834
|
-89.955 nmol/L
Standard Deviation 20.435
|
-129.513 nmol/L
Standard Deviation 26.035
|
-140.922 nmol/L
Standard Deviation 36.663
|
-27.973 nmol/L
Standard Deviation 104.520
|
-200.251 nmol/L
Standard Deviation 40.105
|
-288.874 nmol/L
Standard Deviation 100.724
|
-331.386 nmol/L
Standard Deviation 166.191
|
-353.207 nmol/L
Standard Deviation 193.827
|
|
Change From Baseline in Plasma Lp(a) Levels
Change from baseline to Day 71
|
-0.392 nmol/L
Standard Deviation 14.313
|
-83.970 nmol/L
Standard Deviation 24.076
|
-97.518 nmol/L
Standard Deviation 24.356
|
-88.805 nmol/L
Standard Deviation 22.440
|
-128.797 nmol/L
Standard Deviation 26.709
|
-140.572 nmol/L
Standard Deviation 37.216
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Plasma Lp(a) Levels
Change from baseline to Day 85
|
2.497 nmol/L
Standard Deviation 12.877
|
-73.953 nmol/L
Standard Deviation 23.337
|
-96.318 nmol/L
Standard Deviation 23.377
|
-85.072 nmol/L
Standard Deviation 21.123
|
-127.980 nmol/L
Standard Deviation 27.181
|
-139.255 nmol/L
Standard Deviation 36.247
|
-35.246 nmol/L
Standard Deviation 98.490
|
-185.407 nmol/L
Standard Deviation 42.933
|
-275.519 nmol/L
Standard Deviation 95.029
|
-330.806 nmol/L
Standard Deviation 167.145
|
-352.923 nmol/L
Standard Deviation 194.316
|
|
Change From Baseline in Plasma Lp(a) Levels
Change from baseline to Day 113
|
4.697 nmol/L
Standard Deviation 6.955
|
-63.103 nmol/L
Standard Deviation 28.733
|
-89.168 nmol/L
Standard Deviation 24.019
|
-82.338 nmol/L
Standard Deviation 24.960
|
-123.147 nmol/L
Standard Deviation 26.883
|
-137.038 nmol/L
Standard Deviation 36.491
|
-26.599 nmol/L
Standard Deviation 83.420
|
-162.829 nmol/L
Standard Deviation 50.183
|
-253.641 nmol/L
Standard Deviation 93.836
|
-325.526 nmol/L
Standard Deviation 168.995
|
-276.696 nmol/L
Standard Deviation 75.437
|
|
Change From Baseline in Plasma Lp(a) Levels
Change from baseline to Day 155
|
-13.990 nmol/L
Standard Deviation 14.136
|
—
|
—
|
-63.566 nmol/L
Standard Deviation 26.356
|
-123.076 nmol/L
Standard Deviation 29.946
|
-144.877 nmol/L
Standard Deviation 24.157
|
-32.339 nmol/L
Standard Deviation 101.724
|
-132.696 nmol/L
Standard Deviation 52.950
|
-195.725 nmol/L
Standard Deviation 50.429
|
-304.846 nmol/L
Standard Deviation 173.370
|
-368.258 nmol/L
Standard Deviation 212.962
|
|
Change From Baseline in Plasma Lp(a) Levels
Change from baseline to Day 183
|
-20.770 nmol/L
Standard Deviation 10.748
|
—
|
—
|
—
|
-109.435 nmol/L
Standard Deviation 31.304
|
-140.143 nmol/L
Standard Deviation 25.143
|
-32.749 nmol/L
Standard Deviation 77.047
|
-109.740 nmol/L
Standard Deviation 41.868
|
-176.781 nmol/L
Standard Deviation 51.330
|
-291.966 nmol/L
Standard Deviation 167.126
|
-338.990 nmol/L
Standard Deviation 202.609
|
|
Change From Baseline in Plasma Lp(a) Levels
Change from baseline to Day 225
|
-3.902 nmol/L
Standard Deviation 18.584
|
—
|
—
|
-64.100 nmol/L
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
-104.285 nmol/L
Standard Deviation 36.607
|
-111.892 nmol/L
Standard Deviation 27.648
|
-15.849 nmol/L
Standard Deviation 70.823
|
-85.218 nmol/L
Standard Deviation 39.572
|
-165.297 nmol/L
Standard Deviation 89.184
|
-257.226 nmol/L
Standard Deviation 167.618
|
-320.223 nmol/L
Standard Deviation 207.672
|
|
Change From Baseline in Plasma Lp(a) Levels
Change from baseline to Day 253
|
—
|
—
|
—
|
—
|
—
|
—
|
-101.640 nmol/L
Standard Deviation 58.930
|
—
|
—
|
-276.490 nmol/L
Standard Deviation 179.094
|
-318.725 nmol/L
Standard Deviation 259.063
|
|
Change From Baseline in Plasma Lp(a) Levels
Change from baseline to Day 281
|
—
|
—
|
—
|
—
|
—
|
—
|
-96.107 nmol/L
Standard Deviation 81.127
|
—
|
—
|
-230.106 nmol/L
Standard Deviation 164.525
|
-308.138 nmol/L
Standard Deviation 230.671
|
|
Change From Baseline in Plasma Lp(a) Levels
Change from baseline to Day 309
|
—
|
—
|
—
|
—
|
—
|
—
|
-117.353 nmol/L
Standard Deviation 34.739
|
—
|
—
|
-215.726 nmol/L
Standard Deviation 168.115
|
-299.218 nmol/L
Standard Deviation 232.143
|
|
Change From Baseline in Plasma Lp(a) Levels
Change from baseline to Day 337
|
—
|
—
|
—
|
—
|
—
|
—
|
-113.073 nmol/L
Standard Deviation 84.006
|
—
|
—
|
-198.440 nmol/L
Standard Deviation 162.932
|
-279.478 nmol/L
Standard Deviation 231.897
|
|
Change From Baseline in Plasma Lp(a) Levels
Change from baseline to Day 365
|
—
|
—
|
—
|
—
|
—
|
—
|
-81.653 nmol/L
Standard Deviation 81.061
|
—
|
—
|
-170.126 nmol/L
Standard Deviation 146.154
|
-165.656 nmol/L
Standard Deviation 88.637
|
|
Change From Baseline in Plasma Lp(a) Levels
Change from baseline to Day 2
|
9.740 nmol/L
Standard Deviation 11.415
|
-17.820 nmol/L
Standard Deviation 16.662
|
-1.417 nmol/L
Standard Deviation 9.409
|
9.412 nmol/L
Standard Deviation 13.240
|
1.937 nmol/L
Standard Deviation 2.589
|
-6.438 nmol/L
Standard Deviation 14.001
|
-54.862 nmol/L
Standard Deviation 91.381
|
-4.886 nmol/L
Standard Deviation 24.160
|
-15.119 nmol/L
Standard Deviation 79.070
|
-88.586 nmol/L
Standard Deviation 105.991
|
-86.940 nmol/L
Standard Deviation 134.234
|
|
Change From Baseline in Plasma Lp(a) Levels
Change from baseline to Day 4
|
11.450 nmol/L
Standard Deviation 13.155
|
-13.020 nmol/L
Standard Deviation 17.499
|
-8.317 nmol/L
Standard Deviation 13.271
|
3.862 nmol/L
Standard Deviation 12.344
|
-23.080 nmol/L
Standard Deviation 12.246
|
-13.455 nmol/L
Standard Deviation 11.489
|
-55.527 nmol/L
Standard Deviation 100.807
|
-33.358 nmol/L
Standard Deviation 21.037
|
-49.659 nmol/L
Standard Deviation 70.520
|
-116.986 nmol/L
Standard Deviation 71.397
|
-146.718 nmol/L
Standard Deviation 165.278
|
|
Change From Baseline in Plasma Lp(a) Levels
Change from baseline to Day 7
|
0.410 nmol/L
Standard Deviation 12.785
|
-24.170 nmol/L
Standard Deviation 21.798
|
-35.283 nmol/L
Standard Deviation 13.307
|
-32.272 nmol/L
Standard Deviation 7.480
|
-45.863 nmol/L
Standard Deviation 8.095
|
-69.188 nmol/L
Standard Deviation 35.265
|
-32.389 nmol/L
Standard Deviation 99.479
|
-77.707 nmol/L
Standard Deviation 47.138
|
-102.508 nmol/L
Standard Deviation 75.135
|
-203.215 nmol/L
Standard Deviation 112.549
|
-204.990 nmol/L
Standard Deviation 159.912
|
|
Change From Baseline in Plasma Lp(a) Levels
Change from baseline to Day 15
|
-2.530 nmol/L
Standard Deviation 16.293
|
-59.137 nmol/L
Standard Deviation 28.794
|
-76.094 nmol/L
Standard Deviation 22.915
|
-63.772 nmol/L
Standard Deviation 10.074
|
-96.580 nmol/L
Standard Deviation 11.663
|
-98.938 nmol/L
Standard Deviation 30.749
|
-35.367 nmol/L
Standard Deviation 54.976
|
-138.618 nmol/L
Standard Deviation 38.215
|
-208.459 nmol/L
Standard Deviation 81.219
|
-277.226 nmol/L
Standard Deviation 135.590
|
-294.890 nmol/L
Standard Deviation 176.007
|
|
Change From Baseline in Plasma Lp(a) Levels
Change from baseline to Day 18
|
-6.940 nmol/L
Standard Deviation 15.926
|
-71.070 nmol/L
Standard Deviation 26.156
|
-85.594 nmol/L
Standard Deviation 24.516
|
-76.222 nmol/L
Standard Deviation 13.730
|
-108.463 nmol/L
Standard Deviation 16.162
|
-122.205 nmol/L
Standard Deviation 30.732
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Plasma Lp(a) Levels
Change from baseline to Day 22
|
-3.450 nmol/L
Standard Deviation 14.989
|
-77.853 nmol/L
Standard Deviation 25.502
|
-93.714 nmol/L
Standard Deviation 22.458
|
-79.388 nmol/L
Standard Deviation 15.566
|
-117.813 nmol/L
Standard Deviation 19.714
|
-126.788 nmol/L
Standard Deviation 32.793
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Plasma Lp(a) Levels
Change from baseline to Day 29
|
-1.350 nmol/L
Standard Deviation 14.355
|
-82.037 nmol/L
Standard Deviation 26.703
|
-104.894 nmol/L
Standard Deviation 26.885
|
-86.038 nmol/L
Standard Deviation 18.938
|
-124.713 nmol/L
Standard Deviation 23.769
|
-134.605 nmol/L
Standard Deviation 36.395
|
-46.909 nmol/L
Standard Deviation 72.951
|
-188.740 nmol/L
Standard Deviation 37.700
|
-270.641 nmol/L
Standard Deviation 95.753
|
-330.115 nmol/L
Standard Deviation 171.096
|
-366.214 nmol/L
Standard Deviation 199.738
|
SECONDARY outcome
Timeframe: Cohorts 1-2:Baseline,Days 2,4,7,15,18,22,29,43,57,71,85,113;3-5:Baseline,Days 2,4,7,15,18,22,29,43,57,71,85,113,155,183,225;6-7:Baseline,Days 2,4,7,15,29,43,57,85,113,155,183,225;8-9:Baseline,Days 2,4,7,15,29,43,57,85,113,155,183,225,253,281,309,337,365Population: The PD analysis set consisted of all dosed participants for whom at least one PD parameter had a baseline value and at least 1 post-baseline measurement available. Participants with data available at each timepoint are presented.
Percent change from baseline for plasma Lp(a) by cohort and at scheduled time points during the treatment period were presented.
Outcome measures
| Measure |
Cohorts 1-5: Placebo
n=10 Participants
Participants with screening plasma Lp(a) \>=70 nmol/L and \<199 nmol/L received placebo matching Olpasiran as a single SC injection on Day 1 in cohorts 1 -5.
|
Cohort 1: Olpasiran 3 mg
n=6 Participants
Participants with screening plasma Lp(a) \>=70 nmol/L and \<199 nmol/L received Olpasiran 3 mg as a single SC injection on Day 1.
|
Cohort 2: Olpasiran 9 mg
n=6 Participants
Participants with screening plasma Lp(a) \>=70 nmol/L and \<199 nmol/L received Olpasiran 9 mg as a single SC injection on Day 1.
|
Cohort 3: Olpasiran 30 mg
n=6 Participants
Participants with screening plasma Lp(a) \>=70 nmol/L and \<199 nmol/L received Olpasiran 30 mg as a single SC injection on Day 1.
|
Cohort 4 Olpasiran: 75 mg
n=6 Participants
Participants with screening plasma Lp(a) \>=70 nmol/L and \<199 nmol/L received Olpasiran 75 mg as a single SC injection on Day 1.
|
Cohort 5 Olpasiran: 225 mg
n=6 Participants
Participants with screening plasma Lp(a) \>=70 nmol/L and \<199 nmol/L received Olpasiran 225 mg as a single SC injection on Day 1.
|
Cohorts 6-9: Placebo
n=10 Participants
Participants with screening plasma Lp(a) \>=200 nmol/L received placebo matching Olpasiran as a single SC injection on Day 1 in cohorts 6-9.
|
Cohort 6: Olpasiran 9 mg
n=9 Participants
Participants with screening plasma Lp(a) \>= 200 nmol/L received Olpasiran 9 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment.
|
Cohort 7: Olpasiran 75 mg
n=9 Participants
Participants with screening plasma Lp(a) \>= 200 nmol/L received Olpasiran 75 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment.
|
Cohort 8: Olpasiran 225 mg
n=5 Participants
Participants with screening plasma Lp(a) \>= 200 nmol/L received Olpasiran 225 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment.
|
Cohort 9: Olpasiran 675 mg
n=6 Participants
Participants with screening plasma Lp(a) \>= 200 nmol/L received Olpasiran 675 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Plasma Lp(a) Levels
Percent change from baseline to Day 113
|
3.430 percent change
Standard Deviation 7.307
|
-49.873 percent change
Standard Deviation 16.496
|
-82.051 percent change
Standard Deviation 7.297
|
-79.916 percent change
Standard Deviation 11.140
|
-91.351 percent change
Standard Deviation 6.866
|
-93.926 percent change
Standard Deviation 2.891
|
-6.786 percent change
Standard Deviation 24.282
|
-61.542 percent change
Standard Deviation 17.396
|
-80.484 percent change
Standard Deviation 11.668
|
-96.381 percent change
Standard Deviation 3.343
|
-97.963 percent change
Standard Deviation 1.142
|
|
Percent Change From Baseline in Plasma Lp(a) Levels
Percent change from baseline to Day 155
|
-15.206 percent change
Standard Deviation 14.391
|
—
|
—
|
-56.571 percent change
Standard Deviation 13.156
|
-86.424 percent change
Standard Deviation 11.607
|
-88.415 percent change
Standard Deviation 3.561
|
-7.233 percent change
Standard Deviation 28.936
|
-50.331 percent change
Standard Deviation 20.523
|
-68.537 percent change
Standard Deviation 15.584
|
-89.181 percent change
Standard Deviation 10.167
|
-95.757 percent change
Standard Deviation 4.528
|
|
Percent Change From Baseline in Plasma Lp(a) Levels
Percent change from baseline to Day 183
|
-22.300 percent change
Standard Deviation 6.289
|
—
|
—
|
—
|
-76.956 percent change
Standard Deviation 26.029
|
-85.437 percent change
Standard Deviation 4.356
|
-7.884 percent change
Standard Deviation 23.516
|
-41.792 percent change
Standard Deviation 16.749
|
-60.178 percent change
Standard Deviation 18.037
|
-85.355 percent change
Standard Deviation 11.214
|
-93.357 percent change
Standard Deviation 5.554
|
|
Percent Change From Baseline in Plasma Lp(a) Levels
Percent change from baseline to Day 225
|
-4.934 percent change
Standard Deviation 17.577
|
—
|
—
|
-84.342 percent change
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
-73.464 percent change
Standard Deviation 29.532
|
-81.880 percent change
Standard Deviation 11.062
|
-4.730 percent change
Standard Deviation 23.419
|
-32.228 percent change
Standard Deviation 14.640
|
-51.725 percent change
Standard Deviation 20.701
|
-73.722 percent change
Standard Deviation 17.160
|
-86.702 percent change
Standard Deviation 12.646
|
|
Percent Change From Baseline in Plasma Lp(a) Levels
Percent change from baseline to Day 253
|
—
|
—
|
—
|
—
|
—
|
—
|
-24.858 percent change
Standard Deviation 11.199
|
—
|
—
|
-76.579 percent change
Standard Deviation 15.153
|
-80.199 percent change
Standard Deviation 18.262
|
|
Percent Change From Baseline in Plasma Lp(a) Levels
Percent change from baseline to Day 281
|
—
|
—
|
—
|
—
|
—
|
—
|
-23.787 percent change
Standard Deviation 22.538
|
—
|
—
|
-64.718 percent change
Standard Deviation 19.802
|
-75.169 percent change
Standard Deviation 20.243
|
|
Percent Change From Baseline in Plasma Lp(a) Levels
Percent change from baseline to Day 309
|
—
|
—
|
—
|
—
|
—
|
—
|
-31.515 percent change
Standard Deviation 2.142
|
—
|
—
|
-59.631 percent change
Standard Deviation 21.986
|
-72.336 percent change
Standard Deviation 19.971
|
|
Percent Change From Baseline in Plasma Lp(a) Levels
Percent change from baseline to Day 365
|
—
|
—
|
—
|
—
|
—
|
—
|
-19.333 percent change
Standard Deviation 15.319
|
—
|
—
|
-46.309 percent change
Standard Deviation 23.019
|
-56.484 percent change
Standard Deviation 19.999
|
|
Percent Change From Baseline in Plasma Lp(a) Levels
Percent change from baseline to Day 29
|
-1.630 percent change
Standard Deviation 11.948
|
-65.771 percent change
Standard Deviation 14.454
|
-85.794 percent change
Standard Deviation 7.534
|
-85.001 percent change
Standard Deviation 8.595
|
-92.577 percent change
Standard Deviation 1.368
|
-92.124 percent change
Standard Deviation 3.106
|
-14.805 percent change
Standard Deviation 19.160
|
-72.210 percent change
Standard Deviation 15.684
|
-85.371 percent change
Standard Deviation 7.046
|
-95.448 percent change
Standard Deviation 2.665
|
-95.872 percent change
Standard Deviation 1.879
|
|
Percent Change From Baseline in Plasma Lp(a) Levels
Percent change from baseline to Day 57
|
1.259 percent change
Standard Deviation 10.313
|
-70.163 percent change
Standard Deviation 17.697
|
-87.421 percent change
Standard Deviation 9.001
|
-88.472 percent change
Standard Deviation 6.147
|
-96.014 percent change
Standard Deviation 2.073
|
-96.685 percent change
Standard Deviation 1.316
|
-4.878 percent change
Standard Deviation 25.711
|
-76.174 percent change
Standard Deviation 13.755
|
-91.230 percent change
Standard Deviation 6.742
|
-98.547 percent change
Standard Deviation 0.677
|
-98.956 percent change
Standard Deviation 0.400
|
|
Percent Change From Baseline in Plasma Lp(a) Levels
Percent change from baseline to Day 71
|
-1.546 percent change
Standard Deviation 12.389
|
-67.809 percent change
Standard Deviation 13.524
|
-89.962 percent change
Standard Deviation 4.968
|
-86.866 percent change
Standard Deviation 5.779
|
-95.383 percent change
Standard Deviation 2.145
|
-96.332 percent change
Standard Deviation 1.963
|
—
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in Plasma Lp(a) Levels
Percent change from baseline to Day 337
|
—
|
—
|
—
|
—
|
—
|
—
|
-26.688 percent change
Standard Deviation 15.875
|
—
|
—
|
-52.066 percent change
Standard Deviation 26.070
|
-66.022 percent change
Standard Deviation 23.528
|
|
Percent Change From Baseline in Plasma Lp(a) Levels
Percent change from baseline to Day 2
|
8.407 percent change
Standard Deviation 8.491
|
-13.943 percent change
Standard Deviation 11.951
|
-1.094 percent change
Standard Deviation 7.699
|
8.295 percent change
Standard Deviation 13.665
|
1.415 percent change
Standard Deviation 1.925
|
-4.027 percent change
Standard Deviation 9.484
|
-13.633 percent change
Standard Deviation 21.683
|
-1.570 percent change
Standard Deviation 10.443
|
-2.088 percent change
Standard Deviation 20.604
|
-21.583 percent change
Standard Deviation 17.410
|
-15.998 percent change
Standard Deviation 20.674
|
|
Percent Change From Baseline in Plasma Lp(a) Levels
Percent change from baseline to Day 4
|
11.483 percent change
Standard Deviation 13.532
|
-9.649 percent change
Standard Deviation 12.452
|
-6.487 percent change
Standard Deviation 10.577
|
2.462 percent change
Standard Deviation 12.152
|
-17.185 percent change
Standard Deviation 7.985
|
-8.416 percent change
Standard Deviation 5.613
|
-14.608 percent change
Standard Deviation 23.141
|
-12.800 percent change
Standard Deviation 8.339
|
-13.391 percent change
Standard Deviation 16.046
|
-34.553 percent change
Standard Deviation 16.231
|
-30.307 percent change
Standard Deviation 21.326
|
|
Percent Change From Baseline in Plasma Lp(a) Levels
Percent change from baseline to Day 7
|
0.684 percent change
Standard Deviation 10.535
|
-17.968 percent change
Standard Deviation 15.135
|
-30.135 percent change
Standard Deviation 14.583
|
-34.017 percent change
Standard Deviation 13.052
|
-34.398 percent change
Standard Deviation 4.843
|
-46.725 percent change
Standard Deviation 15.401
|
-7.196 percent change
Standard Deviation 21.378
|
-29.518 percent change
Standard Deviation 15.778
|
-30.979 percent change
Standard Deviation 14.986
|
-58.222 percent change
Standard Deviation 13.332
|
-53.069 percent change
Standard Deviation 12.226
|
|
Percent Change From Baseline in Plasma Lp(a) Levels
Percent change from baseline to Day 15
|
-1.586 percent change
Standard Deviation 13.188
|
-46.805 percent change
Standard Deviation 17.609
|
-61.995 percent change
Standard Deviation 9.342
|
-65.000 percent change
Standard Deviation 15.685
|
-72.512 percent change
Standard Deviation 5.451
|
-69.051 percent change
Standard Deviation 15.864
|
-8.425 percent change
Standard Deviation 12.997
|
-53.145 percent change
Standard Deviation 15.700
|
-66.742 percent change
Standard Deviation 7.852
|
-82.712 percent change
Standard Deviation 7.795
|
-81.166 percent change
Standard Deviation 5.437
|
|
Percent Change From Baseline in Plasma Lp(a) Levels
Percent change from baseline to Day 18
|
-5.992 percent change
Standard Deviation 12.779
|
-56.826 percent change
Standard Deviation 15.047
|
-69.643 percent change
Standard Deviation 6.846
|
-76.332 percent change
Standard Deviation 12.228
|
-81.178 percent change
Standard Deviation 6.122
|
-84.107 percent change
Standard Deviation 3.792
|
—
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in Plasma Lp(a) Levels
Percent change from baseline to Day 22
|
-3.064 percent change
Standard Deviation 11.850
|
-62.268 percent change
Standard Deviation 12.534
|
-77.121 percent change
Standard Deviation 9.413
|
-79.157 percent change
Standard Deviation 11.601
|
-87.780 percent change
Standard Deviation 2.887
|
-87.062 percent change
Standard Deviation 2.254
|
—
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in Plasma Lp(a) Levels
Percent change from baseline to Day 43
|
-6.503 percent change
Standard Deviation 11.507
|
-72.060 percent change
Standard Deviation 12.238
|
-88.761 percent change
Standard Deviation 7.479
|
-88.558 percent change
Standard Deviation 6.473
|
-95.843 percent change
Standard Deviation 1.293
|
-96.365 percent change
Standard Deviation 2.122
|
-12.075 percent change
Standard Deviation 21.690
|
-75.430 percent change
Standard Deviation 14.252
|
-89.637 percent change
Standard Deviation 5.632
|
-98.226 percent change
Standard Deviation 0.645
|
-98.499 percent change
Standard Deviation 0.676
|
|
Percent Change From Baseline in Plasma Lp(a) Levels
Percent change from baseline to Day 85
|
1.275 percent change
Standard Deviation 11.569
|
-59.413 percent change
Standard Deviation 12.808
|
-88.913 percent change
Standard Deviation 4.425
|
-83.628 percent change
Standard Deviation 8.427
|
-94.747 percent change
Standard Deviation 3.108
|
-95.517 percent change
Standard Deviation 2.334
|
-7.875 percent change
Standard Deviation 20.770
|
-70.536 percent change
Standard Deviation 15.558
|
-87.328 percent change
Standard Deviation 7.434
|
-98.275 percent change
Standard Deviation 0.948
|
-98.814 percent change
Standard Deviation 0.608
|
Adverse Events
Cohorts 1-5: Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohorts 6-9: Placebo
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort 1: Olpasiran 3 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 2: Olpasiran 9 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 3: Olpasiran 30 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 4 Olpasiran: 75 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 5 Olpasiran: 225 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 6: Olpasiran 9 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 7: Olpasiran 75 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 8: Olpasiran 225 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 9: Olpasiran 675 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohorts 1-5: Placebo
n=10 participants at risk
Participants with screening plasma Lp(a) \>=70 nmol/L and \<199 nmol/L received placebo matching Olpasiran as a single SC injection on Day 1 in cohorts 1 -5.
|
Cohorts 6-9: Placebo
n=10 participants at risk
Participants with screening plasma Lp(a) \>=200 nmol/L received placebo matching Olpasiran as a single SC injection on Day 1 in cohorts 6-9.
|
Cohort 1: Olpasiran 3 mg
n=6 participants at risk
Participants with screening plasma Lp(a) \>=70 nmol/L and \<199 nmol/L received Olpasiran 3 mg as a single SC injection on Day 1.
|
Cohort 2: Olpasiran 9 mg
n=6 participants at risk
Participants with screening plasma Lp(a) \>=70 nmol/L and \<199 nmol/L received Olpasiran 9 mg as a single SC injection on Day 1.
|
Cohort 3: Olpasiran 30 mg
n=6 participants at risk
Participants with screening plasma Lp(a) \>=70 nmol/L and \<199 nmol/L received Olpasiran 30 mg as a single SC injection on Day 1.
|
Cohort 4 Olpasiran: 75 mg
n=6 participants at risk
Participants with screening plasma Lp(a) \>=70 nmol/L and \<199 nmol/L received Olpasiran 75 mg as a single SC injection on Day 1.
|
Cohort 5 Olpasiran: 225 mg
n=6 participants at risk
Participants with screening plasma Lp(a) \>=70 nmol/L and \<199 nmol/L received Olpasiran 225 mg as a single SC injection on Day 1.
|
Cohort 6: Olpasiran 9 mg
n=9 participants at risk
Participants with screening plasma Lp(a) \>= 200 nmol/L received Olpasiran 9 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment.
|
Cohort 7: Olpasiran 75 mg
n=9 participants at risk
Participants with screening plasma Lp(a) \>= 200 nmol/L received Olpasiran 75 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment.
|
Cohort 8: Olpasiran 225 mg
n=5 participants at risk
Participants with screening plasma Lp(a) \>= 200 nmol/L received Olpasiran 225 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment.
|
Cohort 9: Olpasiran 675 mg
n=6 participants at risk
Participants with screening plasma Lp(a) \>= 200 nmol/L received Olpasiran 675 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
10.0%
1/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Investigations
Cardiac telemetry abnormal
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
10.0%
1/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
Other adverse events
| Measure |
Cohorts 1-5: Placebo
n=10 participants at risk
Participants with screening plasma Lp(a) \>=70 nmol/L and \<199 nmol/L received placebo matching Olpasiran as a single SC injection on Day 1 in cohorts 1 -5.
|
Cohorts 6-9: Placebo
n=10 participants at risk
Participants with screening plasma Lp(a) \>=200 nmol/L received placebo matching Olpasiran as a single SC injection on Day 1 in cohorts 6-9.
|
Cohort 1: Olpasiran 3 mg
n=6 participants at risk
Participants with screening plasma Lp(a) \>=70 nmol/L and \<199 nmol/L received Olpasiran 3 mg as a single SC injection on Day 1.
|
Cohort 2: Olpasiran 9 mg
n=6 participants at risk
Participants with screening plasma Lp(a) \>=70 nmol/L and \<199 nmol/L received Olpasiran 9 mg as a single SC injection on Day 1.
|
Cohort 3: Olpasiran 30 mg
n=6 participants at risk
Participants with screening plasma Lp(a) \>=70 nmol/L and \<199 nmol/L received Olpasiran 30 mg as a single SC injection on Day 1.
|
Cohort 4 Olpasiran: 75 mg
n=6 participants at risk
Participants with screening plasma Lp(a) \>=70 nmol/L and \<199 nmol/L received Olpasiran 75 mg as a single SC injection on Day 1.
|
Cohort 5 Olpasiran: 225 mg
n=6 participants at risk
Participants with screening plasma Lp(a) \>=70 nmol/L and \<199 nmol/L received Olpasiran 225 mg as a single SC injection on Day 1.
|
Cohort 6: Olpasiran 9 mg
n=9 participants at risk
Participants with screening plasma Lp(a) \>= 200 nmol/L received Olpasiran 9 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment.
|
Cohort 7: Olpasiran 75 mg
n=9 participants at risk
Participants with screening plasma Lp(a) \>= 200 nmol/L received Olpasiran 75 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment.
|
Cohort 8: Olpasiran 225 mg
n=5 participants at risk
Participants with screening plasma Lp(a) \>= 200 nmol/L received Olpasiran 225 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment.
|
Cohort 9: Olpasiran 675 mg
n=6 participants at risk
Participants with screening plasma Lp(a) \>= 200 nmol/L received Olpasiran 675 mg as a single SC injection on Day 1. Participants were required to be on a stable dose of statin for at least 6 weeks prior to enrollment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
16.7%
1/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
General disorders
Pain
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
10.0%
1/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
16.7%
1/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Eye disorders
Normal tension glaucoma
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
10.0%
1/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
20.0%
1/5 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
General disorders
Fatigue
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
10.0%
1/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
11.1%
1/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
16.7%
1/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
11.1%
1/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Gastrointestinal disorders
Change of bowel habit
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
10.0%
1/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
11.1%
1/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
16.7%
1/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
16.7%
1/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Gastrointestinal disorders
Oesophageal spasm
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
10.0%
1/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Gastrointestinal disorders
Oral mucosal blistering
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
11.1%
1/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
General disorders
Catheter site pain
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
16.7%
1/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
20.0%
1/5 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
General disorders
Injection site pain
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
20.0%
1/5 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
16.7%
1/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
General disorders
Injection site reaction
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
16.7%
1/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
General disorders
Medical device site dermatitis
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
16.7%
1/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
General disorders
Non-cardiac chest pain
|
10.0%
1/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
16.7%
1/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Infections and infestations
Body tinea
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
11.1%
1/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Infections and infestations
COVID-19
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
20.0%
1/5 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Infections and infestations
Cystitis
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
20.0%
1/5 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
10.0%
1/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
20.0%
1/5 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Infections and infestations
Herpes zoster
|
10.0%
1/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Infections and infestations
Lower respiratory tract infection
|
10.0%
1/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
11.1%
1/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
10.0%
1/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
10.0%
1/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
20.0%
1/5 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
11.1%
1/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.0%
1/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
10.0%
1/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
33.3%
2/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
33.3%
2/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
22.2%
2/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
40.0%
2/5 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
16.7%
1/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
11.1%
1/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Injury, poisoning and procedural complications
Animal scratch
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
11.1%
1/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
16.7%
1/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
11.1%
1/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Injury, poisoning and procedural complications
Ear injury
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
16.7%
1/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Injury, poisoning and procedural complications
Immunisation reaction
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
20.0%
1/5 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
11.1%
1/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Injury, poisoning and procedural complications
Post-traumatic neck syndrome
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
11.1%
1/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
16.7%
1/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
10.0%
1/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Injury, poisoning and procedural complications
Vulvovaginal injury
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
11.1%
1/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Investigations
Blood creatine phosphokinase increased
|
10.0%
1/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
16.7%
1/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Investigations
Blood glucose increased
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
11.1%
1/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Investigations
Smear cervix abnormal
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
20.0%
1/5 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
16.7%
1/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
10.0%
1/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
16.7%
1/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
11.1%
1/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
1/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
16.7%
1/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
11.1%
1/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
11.1%
1/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
16.7%
1/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
11.1%
1/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
10.0%
1/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Nervous system disorders
Headache
|
10.0%
1/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
30.0%
3/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
22.2%
2/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
22.2%
2/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
11.1%
1/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
10.0%
1/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
16.7%
1/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.0%
1/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
10.0%
1/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
11.1%
1/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
11.1%
1/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
16.7%
1/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
10.0%
1/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
16.7%
1/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Skin and subcutaneous tissue disorders
Pseudofolliculitis
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
16.7%
1/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Surgical and medical procedures
Abdominoplasty
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
10.0%
1/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Surgical and medical procedures
Mammoplasty
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
10.0%
1/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Surgical and medical procedures
Tenolysis
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
10.0%
1/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
|
Vascular disorders
Diastolic hypertension
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/10 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/9 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
0.00%
0/5 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
16.7%
1/6 • For all-cause mortality, from randomization until the end of trial completion; median (min, max) time on trial was 8.57 (0.26, 23.95) months. For AE, from first dose of trial drug until the end of trial; median (min, max) duration was 8.54 (0.23, 23.92) months.
All-cause mortality is reported for all participants enrolled/randomized in the trial. Serious AEs and other AEs are reported for all participants who received at least one dose of trial drug.
|
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