Trial Outcomes & Findings for A Safety, Tolerability, and Pharmacokinetics Study of MK-8189 in Participants With Schizophrenia and in Healthy Participants (MK-8189-007) (NCT NCT03565068)
NCT ID: NCT03565068
Last Updated: 2021-03-29
Results Overview
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Per protocol, safety was analyzed by panel and dose. The number of participants who experienced one or more AEs was reported.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
75 participants
Primary outcome timeframe
Up to ~32 days
Results posted on
2021-03-29
Participant Flow
Per protocol-specified dose modification, Panel C MK-8189 dose and schedule were modified, based on tolerability.
Participant milestones
| Measure |
Panel A (Healthy Participants): MK-8189 Monotherapy 4-24 mg
Healthy participants received MK-8189 monotherapy orally once daily (QD) in escalating doses from 4 mg to 24 mg, as follows: Days 1-3: 4 mg, Days 4-6: 8 mg, Days 7-9: 12 mg, Days 10-12: 16 mg, Days 13-15: 20 mg, Days 16-18: 24 mg.
|
Panel A (Healthy Participants): Placebo Monotherapy
Healthy participants received MK-8189 monotherapy matching placebo orally QD on Days 1-18.
|
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 4-24 mg
Participants with Schizophrenia received MK-8189 monotherapy orally QD in escalating doses from 4 mg to 24 mg, as follows: Days 1-3: 4 mg, Days 4-6: 8 mg, Days 7-9: 12 mg, Days 10-12: 16 mg, Days 13-15: 20 mg, Days 16-18: 24 mg.
|
Panel B (Schizophrenia Participants): Placebo Monotherapy
Participants with Schizophrenia received MK-8189 monotherapy matching placebo orally QD on Days 1-18.
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 4-24 mg
In addition to background atypical antipsychotic (AAP) treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD in escalating doses from 4 mg to 24 mg, as follows: Days 1-3: 4 mg, Days 4-6: 8 mg, Days 7-9: 12 mg, Days 10-12: 16 mg, Days 13-15: 20 mg, Days 16-18: 24 mg.
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 4-8 mg
In addition to background AAP treatment, participant with Schizophrenia received modified regimen of MK-8189 add-on therapy orally QD in escalating doses from 4 mg to 8 mg, as follows: Days 1-3: 4 mg, Days 4-11: 8 mg.
|
Panel C (Schizophrenia Participants): Placebo Add-on Therapy
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy matching placebo orally QD on Days 1-18.
|
Panel D (Schizophrenia Participants): MK-8189 Monotherapy 8-48 mg
Participants with Schizophrenia received MK-8189 monotherapy orally QD in escalating doses from 8 mg to 48 mg, as follows: Days 1-3: 8 mg, Days 4-6: 16 mg, Days 7-9: 24 mg, Days 10-12: 36 mg, Days 13-15: 48 mg.
|
Panel D (Schizophrenia Participants): Placebo Monotherapy
Participants with Schizophrenia received MK-8189 monotherapy matching placebo orally QD on Days 1-15.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
4
|
12
|
4
|
12
|
1
|
4
|
17
|
9
|
|
Overall Study
COMPLETED
|
12
|
4
|
11
|
4
|
8
|
0
|
3
|
9
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
4
|
1
|
1
|
8
|
1
|
Reasons for withdrawal
| Measure |
Panel A (Healthy Participants): MK-8189 Monotherapy 4-24 mg
Healthy participants received MK-8189 monotherapy orally once daily (QD) in escalating doses from 4 mg to 24 mg, as follows: Days 1-3: 4 mg, Days 4-6: 8 mg, Days 7-9: 12 mg, Days 10-12: 16 mg, Days 13-15: 20 mg, Days 16-18: 24 mg.
|
Panel A (Healthy Participants): Placebo Monotherapy
Healthy participants received MK-8189 monotherapy matching placebo orally QD on Days 1-18.
|
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 4-24 mg
Participants with Schizophrenia received MK-8189 monotherapy orally QD in escalating doses from 4 mg to 24 mg, as follows: Days 1-3: 4 mg, Days 4-6: 8 mg, Days 7-9: 12 mg, Days 10-12: 16 mg, Days 13-15: 20 mg, Days 16-18: 24 mg.
|
Panel B (Schizophrenia Participants): Placebo Monotherapy
Participants with Schizophrenia received MK-8189 monotherapy matching placebo orally QD on Days 1-18.
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 4-24 mg
In addition to background atypical antipsychotic (AAP) treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD in escalating doses from 4 mg to 24 mg, as follows: Days 1-3: 4 mg, Days 4-6: 8 mg, Days 7-9: 12 mg, Days 10-12: 16 mg, Days 13-15: 20 mg, Days 16-18: 24 mg.
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 4-8 mg
In addition to background AAP treatment, participant with Schizophrenia received modified regimen of MK-8189 add-on therapy orally QD in escalating doses from 4 mg to 8 mg, as follows: Days 1-3: 4 mg, Days 4-11: 8 mg.
|
Panel C (Schizophrenia Participants): Placebo Add-on Therapy
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy matching placebo orally QD on Days 1-18.
|
Panel D (Schizophrenia Participants): MK-8189 Monotherapy 8-48 mg
Participants with Schizophrenia received MK-8189 monotherapy orally QD in escalating doses from 8 mg to 48 mg, as follows: Days 1-3: 8 mg, Days 4-6: 16 mg, Days 7-9: 24 mg, Days 10-12: 36 mg, Days 13-15: 48 mg.
|
Panel D (Schizophrenia Participants): Placebo Monotherapy
Participants with Schizophrenia received MK-8189 monotherapy matching placebo orally QD on Days 1-15.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
|
Overall Study
Sponsor decision
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
2
|
0
|
1
|
5
|
1
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Safety, Tolerability, and Pharmacokinetics Study of MK-8189 in Participants With Schizophrenia and in Healthy Participants (MK-8189-007)
Baseline characteristics by cohort
| Measure |
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 4-24 mg
n=12 Participants
In addition to background atypical antipsychotic (AAP) treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD in escalating doses from 4 mg to 24 mg, as follows: Days 1-3: 4 mg, Days 4-6: 8 mg, Days 7-9: 12 mg, Days 10-12: 16 mg, Days 13-15: 20 mg, Days 16-18: 24 mg.
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 4-8 mg
n=1 Participants
In addition to background AAP treatment, participant with Schizophrenia received modified regimen of MK-8189 add-on therapy orally QD in escalating doses from 4 mg to 8 mg, as follows: Days 1-3: 4 mg, Days 4-11: 8 mg.
|
Panel C (Schizophrenia Participants): Placebo Add-on Therapy
n=4 Participants
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy matching placebo orally QD on Days 1-18.
|
Panel D (Schizophrenia Participants): MK-8189 Monotherapy 8-48 mg
n=17 Participants
Participants with Schizophrenia received MK-8189 monotherapy orally QD in escalating doses from 8 mg to 48 mg, as follows: Days 1-3: 8 mg, Days 4-6: 16 mg, Days 7-9: 24 mg, Days 10-12: 36 mg, Days 13-15: 48 mg.
|
Panel A (Healthy Participants): MK-8189 Monotherapy 4-24 mg
n=12 Participants
Healthy participants received MK-8189 monotherapy orally once daily (QD) in escalating doses from 4 mg to 24 mg, as follows: Days 1-3: 4 mg, Days 4-6: 8 mg, Days 7-9: 12 mg, Days 10-12: 16 mg, Days 13-15: 20 mg, Days 16-18: 24 mg.
|
Panel A (Healthy Participants): Placebo Monotherapy
n=4 Participants
Healthy participants received MK-8189 monotherapy matching placebo orally QD on Days 1-18.
|
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 4-24 mg
n=12 Participants
Participants with Schizophrenia received MK-8189 monotherapy orally QD in escalating doses from 4 mg to 24 mg, as follows: Days 1-3: 4 mg, Days 4-6: 8 mg, Days 7-9: 12 mg, Days 10-12: 16 mg, Days 13-15: 20 mg, Days 16-18: 24 mg.
|
Panel B (Schizophrenia Participants): Placebo Monotherapy
n=4 Participants
Participants with Schizophrenia received MK-8189 monotherapy matching placebo orally QD on Days 1-18.
|
Panel D (Schizophrenia Participants): Placebo Monotherapy
n=9 Participants
Participants with Schizophrenia received MK-8189 monotherapy matching placebo orally QD on Days 1-15.
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
44.3 Years
STANDARD_DEVIATION 7.1 • n=21 Participants
|
51.0 Years
STANDARD_DEVIATION NA • n=8 Participants
|
47.8 Years
STANDARD_DEVIATION 7.2 • n=8 Participants
|
44.4 Years
STANDARD_DEVIATION 10.0 • n=24 Participants
|
36.8 Years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
43.3 Years
STANDARD_DEVIATION 15.4 • n=7 Participants
|
49.3 Years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
44.0 Years
STANDARD_DEVIATION 8.9 • n=4 Participants
|
41.7 Years
STANDARD_DEVIATION 9.6 • n=42 Participants
|
43.8 Years
STANDARD_DEVIATION 9.6 • n=42 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
8 Participants
n=24 Participants
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=42 Participants
|
36 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
9 Participants
n=24 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=42 Participants
|
39 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
15 Participants
n=24 Participants
|
12 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=42 Participants
|
69 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=42 Participants
|
9 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
14 Participants
n=24 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=42 Participants
|
54 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Up to ~32 daysPopulation: All participants who got ≥1 dose of study drug. Per protocol, safety was analyzed by panel and dose.
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Per protocol, safety was analyzed by panel and dose. The number of participants who experienced one or more AEs was reported.
Outcome measures
| Measure |
Panel A (Healthy Participants): MK-8189 Monotherapy 4 mg
n=12 Participants
Healthy participants received MK-8189 monotherapy orally QD at a dose of 4 mg starting on Day 1 and continuing up to Day 3, based on participant tolerability
|
Panel A (Healthy Participants): MK-8189 Monotherapy 8 mg
n=12 Participants
Healthy participants received MK-8189 monotherapy orally QD at a dose of 8 mg starting on Day 4 and continuing up to Day 6, based on participant tolerability
|
Panel A (Healthy Participants): MK-8189 Monotherapy 12 mg
n=11 Participants
Healthy participants received MK-8189 monotherapy orally QD at a dose of 12 mg starting on Day 7 and continuing up to Day 9, based on participant tolerability
|
Panel A (Healthy Participants): MK-8189 Monotherapy 16 mg
n=11 Participants
Healthy participants received MK-8189 monotherapy orally QD at a dose of 16 mg starting on Day 10 and continuing up to Day 12, based on participant tolerability
|
Panel A (Healthy Participants): MK-8189 Monotherapy 20 mg
n=10 Participants
Healthy participants received MK-8189 monotherapy orally QD at a dose of 20 mg starting on Day 13 and continuing up to Day 15, based on participant tolerability
|
Panel A (Healthy Participants): MK-8189 Monotherapy 24 mg
n=10 Participants
Healthy participants received MK-8189 monotherapy orally QD at a dose of 24 mg starting on Day 16 and continuing up to Day 18, based on participant tolerability
|
Panel A (Healthy Participants): Placebo Monotherapy
n=4 Participants
Healthy participants received MK-8189 monotherapy matching placebo orally QD on Days 1-18
|
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 4 mg
n=12 Participants
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 4 mg starting on Day 1 and continuing up to Day 3, based on participant tolerability
|
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 8 mg
n=11 Participants
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 8 mg starting on Day 4 and continuing up to Day 6, based on participant tolerability
|
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 12 mg
n=11 Participants
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 12 mg starting on Day 7 and continuing up to Day 9, based on participant tolerability
|
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 16 mg
n=11 Participants
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 16 mg starting on Day 10 and continuing up to Day 12, based on participant tolerability
|
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 20 mg
n=10 Participants
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 20 mg starting on Day 13 and continuing up to Day 15, based on participant tolerability
|
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 24 mg
n=10 Participants
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 24 mg starting on Day 16 and continuing up to Day 18, based on participant tolerability
|
Panel B (Schizophrenia Participants): Placebo Monotherapy
n=4 Participants
Participants with Schizophrenia received MK-8189 monotherapy matching placebo orally QD from Days 1-18.
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 4 mg
n=13 Participants
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 4 mg starting on Day 1 and continuing up to Day 3, based on participant tolerability
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 8 mg
n=11 Participants
In addition to background AAP treatment, participant with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 8 mg starting on Day 4 and continuing up to Day 11, based on participant tolerability
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 12 mg
n=10 Participants
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 12 mg starting on Day 7 and continuing up to Day 9, based on participant tolerability
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 16 mg
n=8 Participants
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 16 mg starting on Day 10 and continuing up to Day 12, based on participant tolerability
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 20 mg
n=7 Participants
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 20 mg starting on Day 13 and continuing up to Day 15, based on participant tolerability
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 24 mg
n=7 Participants
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 24 mg starting on Day 16 and continuing up to Day 18, based on participant tolerability
|
Panel C (Schizophrenia Participants): Placebo Add-on Therapy
n=4 Participants
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy matching placebo orally QD on Days 1-18
|
Panel D (Schizophrenia Participants): MK-8189 Monotherapy 8 mg
n=17 Participants
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 8 mg starting on Day 1 and continuing up to Day 3, based on participant tolerability
|
Panel D (Schizophrenia Participants): MK-8189 Monotherapy 16 mg
n=16 Participants
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 16 mg starting on Day 4 and continuing up to Day 6, based on participant tolerability
|
Panel D (Schizophrenia Participants): MK-8189 Monotherapy 24 mg
n=15 Participants
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 24 mg starting on Day 7 and continuing up to Day 9, based on participant tolerability
|
Panel D (Schizophrenia Participants): MK-8189 Monotherapy 36 mg
n=13 Participants
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 36 mg starting on Day 10 and continuing up to Day 12, based on participant tolerability
|
Panel D (Schizophrenia Participants): MK-8189 Monotherapy 48 mg
n=11 Participants
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 48 mg starting on Day 13 and continuing up to Day 15, based on participant tolerability
|
Panel D (Schizophrenia Participants): Placebo Monotherapy
n=9 Participants
Participants with Schizophrenia received MK-8189 monotherapy matching placebo orally QD on Days 1-15
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Number of Participants Who Experienced One or More Adverse Events (AEs)
|
5 Participants
|
3 Participants
|
4 Participants
|
5 Participants
|
2 Participants
|
5 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
8 Participants
|
5 Participants
|
7 Participants
|
4 Participants
|
6 Participants
|
8 Participants
|
5 Participants
|
5 Participants
|
4 Participants
|
4 Participants
|
1 Participants
|
8 Participants
|
8 Participants
|
5 Participants
|
5 Participants
|
8 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: Up to ~18 daysPopulation: All participants who got ≥1 dose of study drug. Per protocol, safety was analyzed by panel and dose.
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Per protocol, safety was analyzed by panel and dose. The number of participants who discontinued study treatment due to an AE was reported.
Outcome measures
| Measure |
Panel A (Healthy Participants): MK-8189 Monotherapy 4 mg
n=12 Participants
Healthy participants received MK-8189 monotherapy orally QD at a dose of 4 mg starting on Day 1 and continuing up to Day 3, based on participant tolerability
|
Panel A (Healthy Participants): MK-8189 Monotherapy 8 mg
n=12 Participants
Healthy participants received MK-8189 monotherapy orally QD at a dose of 8 mg starting on Day 4 and continuing up to Day 6, based on participant tolerability
|
Panel A (Healthy Participants): MK-8189 Monotherapy 12 mg
n=11 Participants
Healthy participants received MK-8189 monotherapy orally QD at a dose of 12 mg starting on Day 7 and continuing up to Day 9, based on participant tolerability
|
Panel A (Healthy Participants): MK-8189 Monotherapy 16 mg
n=11 Participants
Healthy participants received MK-8189 monotherapy orally QD at a dose of 16 mg starting on Day 10 and continuing up to Day 12, based on participant tolerability
|
Panel A (Healthy Participants): MK-8189 Monotherapy 20 mg
n=10 Participants
Healthy participants received MK-8189 monotherapy orally QD at a dose of 20 mg starting on Day 13 and continuing up to Day 15, based on participant tolerability
|
Panel A (Healthy Participants): MK-8189 Monotherapy 24 mg
n=10 Participants
Healthy participants received MK-8189 monotherapy orally QD at a dose of 24 mg starting on Day 16 and continuing up to Day 18, based on participant tolerability
|
Panel A (Healthy Participants): Placebo Monotherapy
n=4 Participants
Healthy participants received MK-8189 monotherapy matching placebo orally QD on Days 1-18
|
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 4 mg
n=12 Participants
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 4 mg starting on Day 1 and continuing up to Day 3, based on participant tolerability
|
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 8 mg
n=11 Participants
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 8 mg starting on Day 4 and continuing up to Day 6, based on participant tolerability
|
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 12 mg
n=11 Participants
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 12 mg starting on Day 7 and continuing up to Day 9, based on participant tolerability
|
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 16 mg
n=11 Participants
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 16 mg starting on Day 10 and continuing up to Day 12, based on participant tolerability
|
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 20 mg
n=10 Participants
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 20 mg starting on Day 13 and continuing up to Day 15, based on participant tolerability
|
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 24 mg
n=10 Participants
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 24 mg starting on Day 16 and continuing up to Day 18, based on participant tolerability
|
Panel B (Schizophrenia Participants): Placebo Monotherapy
n=4 Participants
Participants with Schizophrenia received MK-8189 monotherapy matching placebo orally QD from Days 1-18.
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 4 mg
n=13 Participants
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 4 mg starting on Day 1 and continuing up to Day 3, based on participant tolerability
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 8 mg
n=11 Participants
In addition to background AAP treatment, participant with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 8 mg starting on Day 4 and continuing up to Day 11, based on participant tolerability
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 12 mg
n=10 Participants
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 12 mg starting on Day 7 and continuing up to Day 9, based on participant tolerability
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 16 mg
n=8 Participants
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 16 mg starting on Day 10 and continuing up to Day 12, based on participant tolerability
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 20 mg
n=7 Participants
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 20 mg starting on Day 13 and continuing up to Day 15, based on participant tolerability
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 24 mg
n=7 Participants
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 24 mg starting on Day 16 and continuing up to Day 18, based on participant tolerability
|
Panel C (Schizophrenia Participants): Placebo Add-on Therapy
n=4 Participants
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy matching placebo orally QD on Days 1-18
|
Panel D (Schizophrenia Participants): MK-8189 Monotherapy 8 mg
n=17 Participants
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 8 mg starting on Day 1 and continuing up to Day 3, based on participant tolerability
|
Panel D (Schizophrenia Participants): MK-8189 Monotherapy 16 mg
n=16 Participants
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 16 mg starting on Day 4 and continuing up to Day 6, based on participant tolerability
|
Panel D (Schizophrenia Participants): MK-8189 Monotherapy 24 mg
n=15 Participants
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 24 mg starting on Day 7 and continuing up to Day 9, based on participant tolerability
|
Panel D (Schizophrenia Participants): MK-8189 Monotherapy 36 mg
n=13 Participants
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 36 mg starting on Day 10 and continuing up to Day 12, based on participant tolerability
|
Panel D (Schizophrenia Participants): MK-8189 Monotherapy 48 mg
n=11 Participants
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 48 mg starting on Day 13 and continuing up to Day 15, based on participant tolerability
|
Panel D (Schizophrenia Participants): Placebo Monotherapy
n=9 Participants
Participants with Schizophrenia received MK-8189 monotherapy matching placebo orally QD on Days 1-15
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Number of Participants Who Discontinued Study Treatment Due to an AE
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Pre-dose, 2, 6, 8, 10, 12, 16, 24 hours post-dose; no pre-dose on Day 18 (Panel A, B, C), Day 15 (Panel D); Panel A, B: Days 7, 10, 13, 16, 18; Panel C: Days 9, 12, 15, 18; Panel D: Days 1, 4, 7, 10, 13, 15Population: All participants who got ≥1 dose of MK-8189, had AUC0-24hr data for Days 7, 10, 13, 16 or 18 (Panels A, B); Days 9, 12, 15 or 18 (Panel C); Days 1, 4, 7, 10, 13 or 15 (Panel D). Per protocol AUC0-24hr was analyzed by panel, dose, dosing regimen; based on dosing, some arms weren't applicable to some timepoints shown by 0 participants analyzed. The 4 mg, 8 mg (Panels A, B), 4 mg (Panel C) arms weren't applicable to the AUC0-24hr timepoints; per protocol these arms and placebo arms were excluded.
AUC was a measure of MK-8189 exposure assessed as a product of drug concentration and time, using a linear mixed effects model. To estimate AUC0-24hr per protocol blood samples were collected pre-dose, 2, 6, 8, 10, 12, 16, 24 hours post-dose for Panels A, B, C, D; no pre-dose samples collected on Day 18 (Panels A, B, C), Day 15 (Panel D). Samples were collected on Days 7, 10, 13, 16, 18 for Panels A, B; Days 9, 12, 15, 18 for Panel C; Days 1, 4, 7, 10, 13, 15 for Panel D. Per protocol AUC0-24hr was analyzed by panel, dose, dosing regimen; due to differing dosing regimen some arms/doses weren't applicable to some timepoints, shown by 0 participants analyzed in the table. Per dosing regimen the 4 mg, 8 mg (Panels A, B), 4 mg (Panel C) study arms weren't applicable to the protocol-specified timepoints/days of AUC0-24hr analysis and these arms were excluded. Geometric coefficient of variation (GCV) was reported as a percent. Per protocol placebo arms were excluded from AUC0-24hr analysis.
Outcome measures
| Measure |
Panel A (Healthy Participants): MK-8189 Monotherapy 4 mg
Healthy participants received MK-8189 monotherapy orally QD at a dose of 4 mg starting on Day 1 and continuing up to Day 3, based on participant tolerability
|
Panel A (Healthy Participants): MK-8189 Monotherapy 8 mg
Healthy participants received MK-8189 monotherapy orally QD at a dose of 8 mg starting on Day 4 and continuing up to Day 6, based on participant tolerability
|
Panel A (Healthy Participants): MK-8189 Monotherapy 12 mg
n=11 Participants
Healthy participants received MK-8189 monotherapy orally QD at a dose of 12 mg starting on Day 7 and continuing up to Day 9, based on participant tolerability
|
Panel A (Healthy Participants): MK-8189 Monotherapy 16 mg
n=11 Participants
Healthy participants received MK-8189 monotherapy orally QD at a dose of 16 mg starting on Day 10 and continuing up to Day 12, based on participant tolerability
|
Panel A (Healthy Participants): MK-8189 Monotherapy 20 mg
n=10 Participants
Healthy participants received MK-8189 monotherapy orally QD at a dose of 20 mg starting on Day 13 and continuing up to Day 15, based on participant tolerability
|
Panel A (Healthy Participants): MK-8189 Monotherapy 24 mg
n=10 Participants
Healthy participants received MK-8189 monotherapy orally QD at a dose of 24 mg starting on Day 16 and continuing up to Day 18, based on participant tolerability
|
Panel A (Healthy Participants): Placebo Monotherapy
Healthy participants received MK-8189 monotherapy matching placebo orally QD on Days 1-18
|
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 4 mg
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 4 mg starting on Day 1 and continuing up to Day 3, based on participant tolerability
|
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 8 mg
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 8 mg starting on Day 4 and continuing up to Day 6, based on participant tolerability
|
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 12 mg
n=11 Participants
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 12 mg starting on Day 7 and continuing up to Day 9, based on participant tolerability
|
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 16 mg
n=11 Participants
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 16 mg starting on Day 10 and continuing up to Day 12, based on participant tolerability
|
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 20 mg
n=10 Participants
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 20 mg starting on Day 13 and continuing up to Day 15, based on participant tolerability
|
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 24 mg
n=10 Participants
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 24 mg starting on Day 16 and continuing up to Day 18, based on participant tolerability
|
Panel B (Schizophrenia Participants): Placebo Monotherapy
Participants with Schizophrenia received MK-8189 monotherapy matching placebo orally QD from Days 1-18.
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 4 mg
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 4 mg starting on Day 1 and continuing up to Day 3, based on participant tolerability
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 8 mg
n=1 Participants
In addition to background AAP treatment, participant with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 8 mg starting on Day 4 and continuing up to Day 11, based on participant tolerability
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 12 mg
n=10 Participants
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 12 mg starting on Day 7 and continuing up to Day 9, based on participant tolerability
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 16 mg
n=8 Participants
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 16 mg starting on Day 10 and continuing up to Day 12, based on participant tolerability
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 20 mg
n=7 Participants
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 20 mg starting on Day 13 and continuing up to Day 15, based on participant tolerability
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 24 mg
n=7 Participants
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 24 mg starting on Day 16 and continuing up to Day 18, based on participant tolerability
|
Panel C (Schizophrenia Participants): Placebo Add-on Therapy
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy matching placebo orally QD on Days 1-18
|
Panel D (Schizophrenia Participants): MK-8189 Monotherapy 8 mg
n=17 Participants
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 8 mg starting on Day 1 and continuing up to Day 3, based on participant tolerability
|
Panel D (Schizophrenia Participants): MK-8189 Monotherapy 16 mg
n=16 Participants
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 16 mg starting on Day 4 and continuing up to Day 6, based on participant tolerability
|
Panel D (Schizophrenia Participants): MK-8189 Monotherapy 24 mg
n=15 Participants
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 24 mg starting on Day 7 and continuing up to Day 9, based on participant tolerability
|
Panel D (Schizophrenia Participants): MK-8189 Monotherapy 36 mg
n=13 Participants
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 36 mg starting on Day 10 and continuing up to Day 12, based on participant tolerability
|
Panel D (Schizophrenia Participants): MK-8189 Monotherapy 48 mg
n=11 Participants
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 48 mg starting on Day 13 and continuing up to Day 15, based on participant tolerability
|
Panel D (Schizophrenia Participants): Placebo Monotherapy
Participants with Schizophrenia received MK-8189 monotherapy matching placebo orally QD on Days 1-15
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma-concentration Curve at Zero to 24 Hours Post-dose (AUC0-24hr) of MK-8189
Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
4640 nM*hr
Geometric Coefficient of Variation 40.5
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Plasma-concentration Curve at Zero to 24 Hours Post-dose (AUC0-24hr) of MK-8189
Day 4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
10900 nM*hr
Geometric Coefficient of Variation 72.1
|
—
|
—
|
—
|
—
|
|
Area Under the Plasma-concentration Curve at Zero to 24 Hours Post-dose (AUC0-24hr) of MK-8189
Day 7
|
—
|
—
|
8360 nM*hr
Geometric Coefficient of Variation 42.5
|
—
|
—
|
—
|
—
|
—
|
—
|
11700 nM*hr
Geometric Coefficient of Variation 32.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
14100 nM*hr
Geometric Coefficient of Variation 106.6
|
—
|
—
|
—
|
|
Area Under the Plasma-concentration Curve at Zero to 24 Hours Post-dose (AUC0-24hr) of MK-8189
Day 9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
11400 nM*hr
Geometric Coefficient of Variation NA
Measure of dispersion could not be estimated due to low number of participants analyzed
|
11300 nM*hr
Geometric Coefficient of Variation 47.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Plasma-concentration Curve at Zero to 24 Hours Post-dose (AUC0-24hr) of MK-8189
Day 10
|
—
|
—
|
—
|
10200 nM*hr
Geometric Coefficient of Variation 49.0
|
—
|
—
|
—
|
—
|
—
|
—
|
17200 nM*hr
Geometric Coefficient of Variation 41.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
25100 nM*hr
Geometric Coefficient of Variation 54.6
|
—
|
—
|
|
Area Under the Plasma-concentration Curve at Zero to 24 Hours Post-dose (AUC0-24hr) of MK-8189
Day 12
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
13800 nM*hr
Geometric Coefficient of Variation 28.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Plasma-concentration Curve at Zero to 24 Hours Post-dose (AUC0-24hr) of MK-8189
Day 13
|
—
|
—
|
—
|
—
|
12200 nM*hr
Geometric Coefficient of Variation 48.5
|
—
|
—
|
—
|
—
|
—
|
—
|
20200 nM*hr
Geometric Coefficient of Variation 44.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
31800 nM*hr
Geometric Coefficient of Variation 54.5
|
—
|
|
Area Under the Plasma-concentration Curve at Zero to 24 Hours Post-dose (AUC0-24hr) of MK-8189
Day 15
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
15700 nM*hr
Geometric Coefficient of Variation 33.4
|
—
|
—
|
—
|
—
|
—
|
—
|
34400 nM*hr
Geometric Coefficient of Variation 66.5
|
—
|
|
Area Under the Plasma-concentration Curve at Zero to 24 Hours Post-dose (AUC0-24hr) of MK-8189
Day 16
|
—
|
—
|
—
|
—
|
—
|
15600 nM*hr
Geometric Coefficient of Variation 36.1
|
—
|
—
|
—
|
—
|
—
|
—
|
24600 nM*hr
Geometric Coefficient of Variation 36.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Plasma-concentration Curve at Zero to 24 Hours Post-dose (AUC0-24hr) of MK-8189
Day 18
|
—
|
—
|
—
|
—
|
—
|
13600 nM*hr
Geometric Coefficient of Variation 59.6
|
—
|
—
|
—
|
—
|
—
|
—
|
26600 nM*hr
Geometric Coefficient of Variation 38.3
|
—
|
—
|
—
|
—
|
—
|
—
|
18900 nM*hr
Geometric Coefficient of Variation 30.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 2, 6, 8, 10, 12, 16, 24 hours post-dose; no pre-dose on Day 18 (Panel A, B, C), Day 15 (Panel D);additional 36, 48 hours post-dose on Days 18, 15; Panel A, B: Days 7, 10, 13, 16, 18; Panel C: Days 9, 12, 15, 18; Panel D:Days 1, 4, 7, 10, 13, 15Population: All participants who got ≥1 dose of MK-8189, had Cmax data for Days 7, 10, 13, 16 or 18 (Panels A, B); Days 9, 12, 15 or 18 (Panel C); Days 1, 4, 7, 10, 13 or 15 (Panel D). Per protocol Cmax was analyzed by panel, dose, dosing regimen; based on dosing, some arms weren't applicable to some timepoints shown by 0 participants analyzed. The 4 mg, 8 mg (Panels A, B), 4 mg (Panel C) arms weren't applicable to the Cmax timepoints; per protocol these arms and placebo arms were excluded.
Cmax was the maximum concentration of MK-8189 observed in plasma, assessed using a linear mixed effects model. To estimate Cmax, per protocol blood samples were collected pre-dose, 2, 6, 8, 10, 12, 16, 24 hours post-dose for Panels A, B, C, D; no pre-dose samples collected on Day 18 (Panels A, B, C), Day 15 (Panel D); additional post-dose samples collected at 36, 48 hours on Days 18 and 15. Samples were collected on Days 7, 10, 13, 16, 18 for Panels A, B; Days 9, 12, 15, 18 for Panel C; Days 1, 4, 7, 10, 13, 15 for Panel D. Per protocol Cmax was analyzed by panel, dose, dosing regimen; due to differing dosing regimen some arms/doses weren't applicable to some timepoints, shown by 0 participants analyzed in the table. Per dosing regimen, the 4 mg, 8 mg (Panels A, B), 4 mg (Panel C) study arms weren't applicable to the protocol-specified timepoints/days of Cmax analysis and were excluded. GCV was reported as a percent. Per protocol placebo arms were excluded from Cmax analysis.
Outcome measures
| Measure |
Panel A (Healthy Participants): MK-8189 Monotherapy 4 mg
Healthy participants received MK-8189 monotherapy orally QD at a dose of 4 mg starting on Day 1 and continuing up to Day 3, based on participant tolerability
|
Panel A (Healthy Participants): MK-8189 Monotherapy 8 mg
Healthy participants received MK-8189 monotherapy orally QD at a dose of 8 mg starting on Day 4 and continuing up to Day 6, based on participant tolerability
|
Panel A (Healthy Participants): MK-8189 Monotherapy 12 mg
n=11 Participants
Healthy participants received MK-8189 monotherapy orally QD at a dose of 12 mg starting on Day 7 and continuing up to Day 9, based on participant tolerability
|
Panel A (Healthy Participants): MK-8189 Monotherapy 16 mg
n=11 Participants
Healthy participants received MK-8189 monotherapy orally QD at a dose of 16 mg starting on Day 10 and continuing up to Day 12, based on participant tolerability
|
Panel A (Healthy Participants): MK-8189 Monotherapy 20 mg
n=10 Participants
Healthy participants received MK-8189 monotherapy orally QD at a dose of 20 mg starting on Day 13 and continuing up to Day 15, based on participant tolerability
|
Panel A (Healthy Participants): MK-8189 Monotherapy 24 mg
n=10 Participants
Healthy participants received MK-8189 monotherapy orally QD at a dose of 24 mg starting on Day 16 and continuing up to Day 18, based on participant tolerability
|
Panel A (Healthy Participants): Placebo Monotherapy
Healthy participants received MK-8189 monotherapy matching placebo orally QD on Days 1-18
|
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 4 mg
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 4 mg starting on Day 1 and continuing up to Day 3, based on participant tolerability
|
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 8 mg
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 8 mg starting on Day 4 and continuing up to Day 6, based on participant tolerability
|
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 12 mg
n=11 Participants
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 12 mg starting on Day 7 and continuing up to Day 9, based on participant tolerability
|
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 16 mg
n=11 Participants
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 16 mg starting on Day 10 and continuing up to Day 12, based on participant tolerability
|
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 20 mg
n=10 Participants
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 20 mg starting on Day 13 and continuing up to Day 15, based on participant tolerability
|
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 24 mg
n=10 Participants
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 24 mg starting on Day 16 and continuing up to Day 18, based on participant tolerability
|
Panel B (Schizophrenia Participants): Placebo Monotherapy
Participants with Schizophrenia received MK-8189 monotherapy matching placebo orally QD from Days 1-18.
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 4 mg
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 4 mg starting on Day 1 and continuing up to Day 3, based on participant tolerability
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 8 mg
n=1 Participants
In addition to background AAP treatment, participant with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 8 mg starting on Day 4 and continuing up to Day 11, based on participant tolerability
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 12 mg
n=10 Participants
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 12 mg starting on Day 7 and continuing up to Day 9, based on participant tolerability
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 16 mg
n=8 Participants
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 16 mg starting on Day 10 and continuing up to Day 12, based on participant tolerability
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 20 mg
n=7 Participants
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 20 mg starting on Day 13 and continuing up to Day 15, based on participant tolerability
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 24 mg
n=7 Participants
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 24 mg starting on Day 16 and continuing up to Day 18, based on participant tolerability
|
Panel C (Schizophrenia Participants): Placebo Add-on Therapy
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy matching placebo orally QD on Days 1-18
|
Panel D (Schizophrenia Participants): MK-8189 Monotherapy 8 mg
n=17 Participants
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 8 mg starting on Day 1 and continuing up to Day 3, based on participant tolerability
|
Panel D (Schizophrenia Participants): MK-8189 Monotherapy 16 mg
n=16 Participants
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 16 mg starting on Day 4 and continuing up to Day 6, based on participant tolerability
|
Panel D (Schizophrenia Participants): MK-8189 Monotherapy 24 mg
n=15 Participants
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 24 mg starting on Day 7 and continuing up to Day 9, based on participant tolerability
|
Panel D (Schizophrenia Participants): MK-8189 Monotherapy 36 mg
n=13 Participants
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 36 mg starting on Day 10 and continuing up to Day 12, based on participant tolerability
|
Panel D (Schizophrenia Participants): MK-8189 Monotherapy 48 mg
n=11 Participants
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 48 mg starting on Day 13 and continuing up to Day 15, based on participant tolerability
|
Panel D (Schizophrenia Participants): Placebo Monotherapy
Participants with Schizophrenia received MK-8189 monotherapy matching placebo orally QD on Days 1-15
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Post-dose Plasma Concentration (Cmax) of MK-8189
Day 7
|
—
|
—
|
481 nM
Geometric Coefficient of Variation 41.6
|
—
|
—
|
—
|
—
|
—
|
—
|
588 nM
Geometric Coefficient of Variation 33.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
920 nM
Geometric Coefficient of Variation 54.5
|
—
|
—
|
—
|
|
Maximum Observed Post-dose Plasma Concentration (Cmax) of MK-8189
Day 10
|
—
|
—
|
—
|
613 nM
Geometric Coefficient of Variation 37.2
|
—
|
—
|
—
|
—
|
—
|
—
|
868 nM
Geometric Coefficient of Variation 41.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1390 nM
Geometric Coefficient of Variation 46.1
|
—
|
—
|
|
Maximum Observed Post-dose Plasma Concentration (Cmax) of MK-8189
Day 13
|
—
|
—
|
—
|
—
|
709 nM
Geometric Coefficient of Variation 47.1
|
—
|
—
|
—
|
—
|
—
|
—
|
1010 nM
Geometric Coefficient of Variation 45.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1670 nM
Geometric Coefficient of Variation 51.9
|
—
|
|
Maximum Observed Post-dose Plasma Concentration (Cmax) of MK-8189
Day 15
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
801 nM
Geometric Coefficient of Variation 27.3
|
—
|
—
|
—
|
—
|
—
|
—
|
1890 nM
Geometric Coefficient of Variation 52.9
|
—
|
|
Maximum Observed Post-dose Plasma Concentration (Cmax) of MK-8189
Day 16
|
—
|
—
|
—
|
—
|
—
|
807 nM
Geometric Coefficient of Variation 34.0
|
—
|
—
|
—
|
—
|
—
|
—
|
1250 nM
Geometric Coefficient of Variation 37.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Post-dose Plasma Concentration (Cmax) of MK-8189
Day 18
|
—
|
—
|
—
|
—
|
—
|
741 nM
Geometric Coefficient of Variation 48.0
|
—
|
—
|
—
|
—
|
—
|
—
|
1300 nM
Geometric Coefficient of Variation 36.8
|
—
|
—
|
—
|
—
|
—
|
—
|
972 nM
Geometric Coefficient of Variation 23.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Post-dose Plasma Concentration (Cmax) of MK-8189
Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
328 nM
Geometric Coefficient of Variation 42.8
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Post-dose Plasma Concentration (Cmax) of MK-8189
Day 4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
619 nM
Geometric Coefficient of Variation 52.5
|
—
|
—
|
—
|
—
|
|
Maximum Observed Post-dose Plasma Concentration (Cmax) of MK-8189
Day 9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
591 nM
Geometric Coefficient of Variation NA
Measure of dispersion could not be estimated due to low number of participants analyzed
|
566 nM
Geometric Coefficient of Variation 46.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Post-dose Plasma Concentration (Cmax) of MK-8189
Day 12
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
693 nM
Geometric Coefficient of Variation 24.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 24 hours post-dose; Panel A, B: Days 7, 10, 13, 16, 18; Panel C: Days 9, 12, 15, 18; Panel D: Days 1, 4, 7, 10, 13, 15Population: All participants who got ≥1 dose of MK-8189, had C24hr data for Days 7, 10, 13, 16 or 18 (Panels A, B); Days 9, 12, 15 or 18 (Panel C); Days 1, 4, 7, 10, 13 or 15 (Panel D). Per protocol C24hr was analyzed by panel, dose, dosing regimen; based on dosing, some arms weren't applicable to some timepoints shown by 0 participants analyzed. The 4 mg, 8 mg (Panels A, B), 4 mg (Panel C) arms weren't applicable to the C24hr timepoints; per protocol these arms and placebo arms were excluded.
C24hr was the concentration of MK-8189 observed in plasma at the 24-hour nominal sampling time after administration of MK-8189, assessed using a linear mixed effects model. To estimate C24hr, per protocol blood samples were collected 24 hours post-dose on Days 7, 10, 13, 16, 18 for Panels A, B; Days 9, 12, 15, 18 for Panel C; Days 1, 4, 7, 10, 13, 15 for Panel D. Per protocol C24hr was analyzed by panel, dose, dosing regimen; due to differing dosing regimen some arms/doses weren't applicable to some timepoints, shown by 0 participants analyzed in the table. Per dosing regimen, the 4 mg, 8 mg (Panels A, B), 4 mg (Panel C) study arms weren't applicable to the protocol-specified timepoints/days of C24hr analysis and were excluded. GCV was reported as a percent. Per protocol placebo arms were excluded from C24hr analysis.
Outcome measures
| Measure |
Panel A (Healthy Participants): MK-8189 Monotherapy 4 mg
Healthy participants received MK-8189 monotherapy orally QD at a dose of 4 mg starting on Day 1 and continuing up to Day 3, based on participant tolerability
|
Panel A (Healthy Participants): MK-8189 Monotherapy 8 mg
Healthy participants received MK-8189 monotherapy orally QD at a dose of 8 mg starting on Day 4 and continuing up to Day 6, based on participant tolerability
|
Panel A (Healthy Participants): MK-8189 Monotherapy 12 mg
n=11 Participants
Healthy participants received MK-8189 monotherapy orally QD at a dose of 12 mg starting on Day 7 and continuing up to Day 9, based on participant tolerability
|
Panel A (Healthy Participants): MK-8189 Monotherapy 16 mg
n=6 Participants
Healthy participants received MK-8189 monotherapy orally QD at a dose of 16 mg starting on Day 10 and continuing up to Day 12, based on participant tolerability
|
Panel A (Healthy Participants): MK-8189 Monotherapy 20 mg
n=10 Participants
Healthy participants received MK-8189 monotherapy orally QD at a dose of 20 mg starting on Day 13 and continuing up to Day 15, based on participant tolerability
|
Panel A (Healthy Participants): MK-8189 Monotherapy 24 mg
n=10 Participants
Healthy participants received MK-8189 monotherapy orally QD at a dose of 24 mg starting on Day 16 and continuing up to Day 18, based on participant tolerability
|
Panel A (Healthy Participants): Placebo Monotherapy
Healthy participants received MK-8189 monotherapy matching placebo orally QD on Days 1-18
|
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 4 mg
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 4 mg starting on Day 1 and continuing up to Day 3, based on participant tolerability
|
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 8 mg
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 8 mg starting on Day 4 and continuing up to Day 6, based on participant tolerability
|
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 12 mg
n=11 Participants
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 12 mg starting on Day 7 and continuing up to Day 9, based on participant tolerability
|
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 16 mg
n=11 Participants
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 16 mg starting on Day 10 and continuing up to Day 12, based on participant tolerability
|
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 20 mg
n=10 Participants
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 20 mg starting on Day 13 and continuing up to Day 15, based on participant tolerability
|
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 24 mg
n=10 Participants
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 24 mg starting on Day 16 and continuing up to Day 18, based on participant tolerability
|
Panel B (Schizophrenia Participants): Placebo Monotherapy
Participants with Schizophrenia received MK-8189 monotherapy matching placebo orally QD from Days 1-18.
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 4 mg
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 4 mg starting on Day 1 and continuing up to Day 3, based on participant tolerability
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 8 mg
n=1 Participants
In addition to background AAP treatment, participant with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 8 mg starting on Day 4 and continuing up to Day 11, based on participant tolerability
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 12 mg
n=10 Participants
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 12 mg starting on Day 7 and continuing up to Day 9, based on participant tolerability
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 16 mg
n=8 Participants
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 16 mg starting on Day 10 and continuing up to Day 12, based on participant tolerability
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 20 mg
n=6 Participants
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 20 mg starting on Day 13 and continuing up to Day 15, based on participant tolerability
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 24 mg
n=7 Participants
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 24 mg starting on Day 16 and continuing up to Day 18, based on participant tolerability
|
Panel C (Schizophrenia Participants): Placebo Add-on Therapy
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy matching placebo orally QD on Days 1-18
|
Panel D (Schizophrenia Participants): MK-8189 Monotherapy 8 mg
n=17 Participants
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 8 mg starting on Day 1 and continuing up to Day 3, based on participant tolerability
|
Panel D (Schizophrenia Participants): MK-8189 Monotherapy 16 mg
n=16 Participants
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 16 mg starting on Day 4 and continuing up to Day 6, based on participant tolerability
|
Panel D (Schizophrenia Participants): MK-8189 Monotherapy 24 mg
n=14 Participants
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 24 mg starting on Day 7 and continuing up to Day 9, based on participant tolerability
|
Panel D (Schizophrenia Participants): MK-8189 Monotherapy 36 mg
n=13 Participants
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 36 mg starting on Day 10 and continuing up to Day 12, based on participant tolerability
|
Panel D (Schizophrenia Participants): MK-8189 Monotherapy 48 mg
n=11 Participants
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 48 mg starting on Day 13 and continuing up to Day 15, based on participant tolerability
|
Panel D (Schizophrenia Participants): Placebo Monotherapy
Participants with Schizophrenia received MK-8189 monotherapy matching placebo orally QD on Days 1-15
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Plasma Concentration at 24 Hours Post-dose (C24hr) of MK-8189
Day 4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
480 nM
Geometric Coefficient of Variation 101.8
|
—
|
—
|
—
|
—
|
|
Plasma Concentration at 24 Hours Post-dose (C24hr) of MK-8189
Day 7
|
—
|
—
|
310 nM
Geometric Coefficient of Variation 47.2
|
—
|
—
|
—
|
—
|
—
|
—
|
501 nM
Geometric Coefficient of Variation 37.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
567 nM
Geometric Coefficient of Variation 131.4
|
—
|
—
|
—
|
|
Plasma Concentration at 24 Hours Post-dose (C24hr) of MK-8189
Day 9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
416 nM
Geometric Coefficient of Variation NA
Measure of dispersion could not be estimated due to low number of participants analyzed
|
490 nM
Geometric Coefficient of Variation 54.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Plasma Concentration at 24 Hours Post-dose (C24hr) of MK-8189
Day 10
|
—
|
—
|
—
|
392 nM
Geometric Coefficient of Variation 61.4
|
—
|
—
|
—
|
—
|
—
|
—
|
702 nM
Geometric Coefficient of Variation 46.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
890 nM
Geometric Coefficient of Variation 80.3
|
—
|
—
|
|
Plasma Concentration at 24 Hours Post-dose (C24hr) of MK-8189
Day 13
|
—
|
—
|
—
|
—
|
418 nM
Geometric Coefficient of Variation 65.0
|
—
|
—
|
—
|
—
|
—
|
—
|
836 nM
Geometric Coefficient of Variation 57.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1370 nM
Geometric Coefficient of Variation 47.5
|
—
|
|
Plasma Concentration at 24 Hours Post-dose (C24hr) of MK-8189
Day 16
|
—
|
—
|
—
|
—
|
—
|
625 nM
Geometric Coefficient of Variation 39.7
|
—
|
—
|
—
|
—
|
—
|
—
|
949 nM
Geometric Coefficient of Variation 45.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Plasma Concentration at 24 Hours Post-dose (C24hr) of MK-8189
Day 18
|
—
|
—
|
—
|
—
|
—
|
433 nM
Geometric Coefficient of Variation 111.3
|
—
|
—
|
—
|
—
|
—
|
—
|
1010 nM
Geometric Coefficient of Variation 47.5
|
—
|
—
|
—
|
—
|
—
|
—
|
704 nM
Geometric Coefficient of Variation 39.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Plasma Concentration at 24 Hours Post-dose (C24hr) of MK-8189
Day 15
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
651 nM
Geometric Coefficient of Variation 44.1
|
—
|
—
|
—
|
—
|
—
|
—
|
1160 nM
Geometric Coefficient of Variation 97.8
|
—
|
|
Plasma Concentration at 24 Hours Post-dose (C24hr) of MK-8189
Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
287 nM
Geometric Coefficient of Variation 70.3
|
—
|
—
|
—
|
—
|
—
|
|
Plasma Concentration at 24 Hours Post-dose (C24hr) of MK-8189
Day 12
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
540 nM
Geometric Coefficient of Variation 39.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 2, 6, 8, 10, 12, 16, 24 hours post-dose; no pre-dose on Day 18 (Panel A, B, C), Day 15 (Panel D);additional 36, 48 hours post-dose on Days 18, 15; Panel A, B: Days 7, 10, 13, 16, 18; Panel C: Days 9, 12, 15, 18; Panel D:Days 1, 4, 7, 10, 13, 15Population: All participants who got ≥1 dose of MK-8189, had Tmax data for Days 7, 10, 13, 16 or 18 (Panels A, B); Days 9, 12, 15 or 18 (Panel C); Days 1, 4, 7, 10, 13 or 15 (Panel D). Per protocol Tmax was analyzed by panel, dose, dosing regimen; based on dosing, some arms weren't applicable to some timepoints shown by 0 participants analyzed. The 4 mg, 8 mg (Panels A, B), 4 mg (Panel C) arms weren't applicable to the Tmax timepoints; per protocol these arms and placebo arms were excluded.
Tmax was the actual sampling time at which maximum post-dose plasma concentration of MK-8189 was observed. To estimate Tmax, per protocol blood samples were collected pre-dose, 2, 6, 8, 10, 12, 16, 24 hours post-dose for Panels A, B, C, D; no pre-dose samples collected on Day 18 (Panels A, B, C), Day 15 (Panel D); additional post-dose samples collected at 36, 48 hours on Days 18 and 15. Samples were collected on Days 7, 10, 13, 16, 18 for Panels A, B; Days 9, 12, 15, 18 for Panel C; Days 1, 4, 7, 10, 13, 15 for Panel D. Per protocol Tmax was analyzed by panel, dose, dosing regimen; due to differing dosing regimen, some arms/doses weren't applicable to some timepoints, shown by 0 participants analyzed in the table. Per dosing regimen, the 4 mg, 8 mg (Panels A, B), 4 mg (Panel C) study arms weren't applicable to the protocol-specified timepoints/days of Tmax analysis and were excluded. Per protocol placebo arms were excluded from Tmax analysis.
Outcome measures
| Measure |
Panel A (Healthy Participants): MK-8189 Monotherapy 4 mg
Healthy participants received MK-8189 monotherapy orally QD at a dose of 4 mg starting on Day 1 and continuing up to Day 3, based on participant tolerability
|
Panel A (Healthy Participants): MK-8189 Monotherapy 8 mg
Healthy participants received MK-8189 monotherapy orally QD at a dose of 8 mg starting on Day 4 and continuing up to Day 6, based on participant tolerability
|
Panel A (Healthy Participants): MK-8189 Monotherapy 12 mg
n=11 Participants
Healthy participants received MK-8189 monotherapy orally QD at a dose of 12 mg starting on Day 7 and continuing up to Day 9, based on participant tolerability
|
Panel A (Healthy Participants): MK-8189 Monotherapy 16 mg
n=11 Participants
Healthy participants received MK-8189 monotherapy orally QD at a dose of 16 mg starting on Day 10 and continuing up to Day 12, based on participant tolerability
|
Panel A (Healthy Participants): MK-8189 Monotherapy 20 mg
n=10 Participants
Healthy participants received MK-8189 monotherapy orally QD at a dose of 20 mg starting on Day 13 and continuing up to Day 15, based on participant tolerability
|
Panel A (Healthy Participants): MK-8189 Monotherapy 24 mg
n=10 Participants
Healthy participants received MK-8189 monotherapy orally QD at a dose of 24 mg starting on Day 16 and continuing up to Day 18, based on participant tolerability
|
Panel A (Healthy Participants): Placebo Monotherapy
Healthy participants received MK-8189 monotherapy matching placebo orally QD on Days 1-18
|
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 4 mg
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 4 mg starting on Day 1 and continuing up to Day 3, based on participant tolerability
|
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 8 mg
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 8 mg starting on Day 4 and continuing up to Day 6, based on participant tolerability
|
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 12 mg
n=11 Participants
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 12 mg starting on Day 7 and continuing up to Day 9, based on participant tolerability
|
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 16 mg
n=11 Participants
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 16 mg starting on Day 10 and continuing up to Day 12, based on participant tolerability
|
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 20 mg
n=10 Participants
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 20 mg starting on Day 13 and continuing up to Day 15, based on participant tolerability
|
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 24 mg
n=10 Participants
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 24 mg starting on Day 16 and continuing up to Day 18, based on participant tolerability
|
Panel B (Schizophrenia Participants): Placebo Monotherapy
Participants with Schizophrenia received MK-8189 monotherapy matching placebo orally QD from Days 1-18.
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 4 mg
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 4 mg starting on Day 1 and continuing up to Day 3, based on participant tolerability
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 8 mg
n=1 Participants
In addition to background AAP treatment, participant with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 8 mg starting on Day 4 and continuing up to Day 11, based on participant tolerability
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 12 mg
n=10 Participants
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 12 mg starting on Day 7 and continuing up to Day 9, based on participant tolerability
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 16 mg
n=8 Participants
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 16 mg starting on Day 10 and continuing up to Day 12, based on participant tolerability
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 20 mg
n=7 Participants
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 20 mg starting on Day 13 and continuing up to Day 15, based on participant tolerability
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 24 mg
n=7 Participants
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 24 mg starting on Day 16 and continuing up to Day 18, based on participant tolerability
|
Panel C (Schizophrenia Participants): Placebo Add-on Therapy
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy matching placebo orally QD on Days 1-18
|
Panel D (Schizophrenia Participants): MK-8189 Monotherapy 8 mg
n=17 Participants
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 8 mg starting on Day 1 and continuing up to Day 3, based on participant tolerability
|
Panel D (Schizophrenia Participants): MK-8189 Monotherapy 16 mg
n=16 Participants
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 16 mg starting on Day 4 and continuing up to Day 6, based on participant tolerability
|
Panel D (Schizophrenia Participants): MK-8189 Monotherapy 24 mg
n=15 Participants
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 24 mg starting on Day 7 and continuing up to Day 9, based on participant tolerability
|
Panel D (Schizophrenia Participants): MK-8189 Monotherapy 36 mg
n=13 Participants
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 36 mg starting on Day 10 and continuing up to Day 12, based on participant tolerability
|
Panel D (Schizophrenia Participants): MK-8189 Monotherapy 48 mg
n=11 Participants
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 48 mg starting on Day 13 and continuing up to Day 15, based on participant tolerability
|
Panel D (Schizophrenia Participants): Placebo Monotherapy
Participants with Schizophrenia received MK-8189 monotherapy matching placebo orally QD on Days 1-15
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time Post-dose to Maximum Observed Plasma Concentration (Tmax) of MK-8189
Day 7
|
—
|
—
|
12.02 hr
Interval 8.0 to 16.02
|
—
|
—
|
—
|
—
|
—
|
—
|
15.98 hr
Interval 6.0 to 23.95
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
16.03 hr
Interval 0.0 to 23.97
|
—
|
—
|
—
|
|
Time Post-dose to Maximum Observed Plasma Concentration (Tmax) of MK-8189
Day 10
|
—
|
—
|
—
|
16.02 hr
Interval 10.03 to 23.95
|
—
|
—
|
—
|
—
|
—
|
—
|
16.07 hr
Interval 10.03 to 23.98
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
12.00 hr
Interval 0.0 to 23.95
|
—
|
—
|
|
Time Post-dose to Maximum Observed Plasma Concentration (Tmax) of MK-8189
Day 13
|
—
|
—
|
—
|
—
|
14.04 hr
Interval 0.0 to 16.1
|
—
|
—
|
—
|
—
|
—
|
—
|
16.05 hr
Interval 6.0 to 24.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
16.02 hr
Interval 8.0 to 16.15
|
—
|
|
Time Post-dose to Maximum Observed Plasma Concentration (Tmax) of MK-8189
Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
23.95 hr
Interval 12.0 to 24.0
|
—
|
—
|
—
|
—
|
—
|
|
Time Post-dose to Maximum Observed Plasma Concentration (Tmax) of MK-8189
Day 4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
12.04 hr
Interval 0.0 to 23.98
|
—
|
—
|
—
|
—
|
|
Time Post-dose to Maximum Observed Plasma Concentration (Tmax) of MK-8189
Day 9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
12.00 hr
Measure of dispersion could not be estimated due to low number of participants analyzed
|
15.99 hr
Interval 2.0 to 23.92
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time Post-dose to Maximum Observed Plasma Concentration (Tmax) of MK-8189
Day 12
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
11.09 hr
Interval 0.0 to 23.92
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time Post-dose to Maximum Observed Plasma Concentration (Tmax) of MK-8189
Day 15
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
16.00 hr
Interval 6.0 to 23.95
|
—
|
—
|
—
|
—
|
—
|
—
|
16.02 hr
Interval 6.05 to 16.13
|
—
|
|
Time Post-dose to Maximum Observed Plasma Concentration (Tmax) of MK-8189
Day 16
|
—
|
—
|
—
|
—
|
—
|
13.99 hr
Interval 6.0 to 16.03
|
—
|
—
|
—
|
—
|
—
|
—
|
10.09 hr
Interval 6.0 to 23.93
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time Post-dose to Maximum Observed Plasma Concentration (Tmax) of MK-8189
Day 18
|
—
|
—
|
—
|
—
|
—
|
11.99 hr
Interval 8.0 to 16.03
|
—
|
—
|
—
|
—
|
—
|
—
|
12.05 hr
Interval 8.02 to 16.07
|
—
|
—
|
—
|
—
|
—
|
—
|
12.00 hr
Interval 6.0 to 16.07
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 2, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose on Day 18 (Panel A, B, C) and Day 15 (Panel D)Population: All participants who got ≥1 dose of MK-8189, had CL/F data for Day 18 (Panels A, B, C) or Day 15 (Panel D). Per protocol CL/F was analyzed by panel, dose, dosing regimen; based on dosing, some arms weren't applicable to some timepoints, shown by 0 participants analyzed. The 4 mg, 8 mg, 12 mg, 16 mg, 20 mg (Panels A, B, C), 8 mg, 16 mg, 24 mg, 36 mg (Panel D) arms weren't applicable to the CL/F timepoints; per protocol these arms and placebo arms were excluded.
CL/F was the apparent total clearance of MK-8189 in plasma over time, assessed as the rate at which MK-8189 was removed from the plasma. To estimate CL/F, per protocol blood samples were collected 2, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose on Day 18 for Panels A, B, C, and on Day 15 for Panel D. Per protocol CL/F was analyzed by panel, dose and dosing regimen. Due to differing dosing regimen, some arms/doses weren't applicable to some timepoints, shown by 0 participants analyzed in the table. Per dosing regimen, the 4 mg, 8 mg, 12 mg, 16 mg, 20 mg (Panels A, B, C), 8 mg, 16 mg, 24 mg, 36 mg (Panel D) study arms weren't applicable to the protocol-specified timepoints/days of CL/F analysis and were excluded. GCV was reported as a percent. Per protocol placebo arms were excluded from CL/F analysis.
Outcome measures
| Measure |
Panel A (Healthy Participants): MK-8189 Monotherapy 4 mg
Healthy participants received MK-8189 monotherapy orally QD at a dose of 4 mg starting on Day 1 and continuing up to Day 3, based on participant tolerability
|
Panel A (Healthy Participants): MK-8189 Monotherapy 8 mg
Healthy participants received MK-8189 monotherapy orally QD at a dose of 8 mg starting on Day 4 and continuing up to Day 6, based on participant tolerability
|
Panel A (Healthy Participants): MK-8189 Monotherapy 12 mg
Healthy participants received MK-8189 monotherapy orally QD at a dose of 12 mg starting on Day 7 and continuing up to Day 9, based on participant tolerability
|
Panel A (Healthy Participants): MK-8189 Monotherapy 16 mg
Healthy participants received MK-8189 monotherapy orally QD at a dose of 16 mg starting on Day 10 and continuing up to Day 12, based on participant tolerability
|
Panel A (Healthy Participants): MK-8189 Monotherapy 20 mg
Healthy participants received MK-8189 monotherapy orally QD at a dose of 20 mg starting on Day 13 and continuing up to Day 15, based on participant tolerability
|
Panel A (Healthy Participants): MK-8189 Monotherapy 24 mg
n=10 Participants
Healthy participants received MK-8189 monotherapy orally QD at a dose of 24 mg starting on Day 16 and continuing up to Day 18, based on participant tolerability
|
Panel A (Healthy Participants): Placebo Monotherapy
Healthy participants received MK-8189 monotherapy matching placebo orally QD on Days 1-18
|
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 4 mg
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 4 mg starting on Day 1 and continuing up to Day 3, based on participant tolerability
|
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 8 mg
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 8 mg starting on Day 4 and continuing up to Day 6, based on participant tolerability
|
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 12 mg
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 12 mg starting on Day 7 and continuing up to Day 9, based on participant tolerability
|
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 16 mg
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 16 mg starting on Day 10 and continuing up to Day 12, based on participant tolerability
|
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 20 mg
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 20 mg starting on Day 13 and continuing up to Day 15, based on participant tolerability
|
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 24 mg
n=10 Participants
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 24 mg starting on Day 16 and continuing up to Day 18, based on participant tolerability
|
Panel B (Schizophrenia Participants): Placebo Monotherapy
Participants with Schizophrenia received MK-8189 monotherapy matching placebo orally QD from Days 1-18.
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 4 mg
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 4 mg starting on Day 1 and continuing up to Day 3, based on participant tolerability
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 8 mg
In addition to background AAP treatment, participant with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 8 mg starting on Day 4 and continuing up to Day 11, based on participant tolerability
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 12 mg
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 12 mg starting on Day 7 and continuing up to Day 9, based on participant tolerability
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 16 mg
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 16 mg starting on Day 10 and continuing up to Day 12, based on participant tolerability
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 20 mg
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 20 mg starting on Day 13 and continuing up to Day 15, based on participant tolerability
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 24 mg
n=7 Participants
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 24 mg starting on Day 16 and continuing up to Day 18, based on participant tolerability
|
Panel C (Schizophrenia Participants): Placebo Add-on Therapy
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy matching placebo orally QD on Days 1-18
|
Panel D (Schizophrenia Participants): MK-8189 Monotherapy 8 mg
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 8 mg starting on Day 1 and continuing up to Day 3, based on participant tolerability
|
Panel D (Schizophrenia Participants): MK-8189 Monotherapy 16 mg
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 16 mg starting on Day 4 and continuing up to Day 6, based on participant tolerability
|
Panel D (Schizophrenia Participants): MK-8189 Monotherapy 24 mg
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 24 mg starting on Day 7 and continuing up to Day 9, based on participant tolerability
|
Panel D (Schizophrenia Participants): MK-8189 Monotherapy 36 mg
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 36 mg starting on Day 10 and continuing up to Day 12, based on participant tolerability
|
Panel D (Schizophrenia Participants): MK-8189 Monotherapy 48 mg
n=11 Participants
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 48 mg starting on Day 13 and continuing up to Day 15, based on participant tolerability
|
Panel D (Schizophrenia Participants): Placebo Monotherapy
Participants with Schizophrenia received MK-8189 monotherapy matching placebo orally QD on Days 1-15
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Total Plasma Clearance of MK-8189 (CL/F) on Day 18 (Panels A, B, C) and Day 15 (Panel D)
Day 15
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
3.65 Liter/hr
Geometric Coefficient of Variation 66.5
|
—
|
|
Apparent Total Plasma Clearance of MK-8189 (CL/F) on Day 18 (Panels A, B, C) and Day 15 (Panel D)
Day 18
|
—
|
—
|
—
|
—
|
—
|
4.63 Liter/hr
Geometric Coefficient of Variation 59.6
|
—
|
—
|
—
|
—
|
—
|
—
|
2.36 Liter/hr
Geometric Coefficient of Variation 38.3
|
—
|
—
|
—
|
—
|
—
|
—
|
3.32 Liter/hr
Geometric Coefficient of Variation 30.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 2, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose on Day 18 (Panel A, B, C) and Day 15 (Panel D)Population: All participants who got ≥1 dose of MK-8189, had Vd/F data for Day 18 (Panels A, B, C) or Day 15 (Panel D). Per protocol Vd/F was analyzed by panel, dose, dosing regimen; based on dosing, some arms weren't applicable to some timepoints, shown by 0 participants analyzed. The 4 mg, 8 mg, 12 mg, 16 mg, 20 mg (Panels A, B, C), 8 mg, 16 mg, 24 mg, 36 mg (Panel D) arms weren't applicable to the Vd/F timepoints; per protocol these arms and placebo arms were excluded.
Vd/F was the apparent volume of distribution of MK-8189 between the plasma and the rest of the body, after dose, assessed as the total volume of MK-8189 that would need to be uniformly distributed to achieve the desired plasma drug concentration. To estimate Vd/F, per protocol blood samples were collected 2, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose on Day 18 for Panels A, B, C, and on Day 15 for Panel D. Per protocol Vd/F was analyzed by panel, dose and dosing regimen. Due to differing dosing regimen, some arms/doses weren't applicable to some timepoints, shown by 0 participants analyzed in the table. Per dosing regimen, the 4 mg, 8 mg, 12 mg, 16 mg, 20 mg (Panels A, B, C), 8 mg, 16 mg, 24 mg, 36 mg (Panel D) study arms weren't applicable to the protocol-specified timepoints/days of Vd/F analysis and were excluded. GCV was reported as a percent. Per protocol placebo arms were excluded from Vd/F analysis.
Outcome measures
| Measure |
Panel A (Healthy Participants): MK-8189 Monotherapy 4 mg
Healthy participants received MK-8189 monotherapy orally QD at a dose of 4 mg starting on Day 1 and continuing up to Day 3, based on participant tolerability
|
Panel A (Healthy Participants): MK-8189 Monotherapy 8 mg
Healthy participants received MK-8189 monotherapy orally QD at a dose of 8 mg starting on Day 4 and continuing up to Day 6, based on participant tolerability
|
Panel A (Healthy Participants): MK-8189 Monotherapy 12 mg
Healthy participants received MK-8189 monotherapy orally QD at a dose of 12 mg starting on Day 7 and continuing up to Day 9, based on participant tolerability
|
Panel A (Healthy Participants): MK-8189 Monotherapy 16 mg
Healthy participants received MK-8189 monotherapy orally QD at a dose of 16 mg starting on Day 10 and continuing up to Day 12, based on participant tolerability
|
Panel A (Healthy Participants): MK-8189 Monotherapy 20 mg
Healthy participants received MK-8189 monotherapy orally QD at a dose of 20 mg starting on Day 13 and continuing up to Day 15, based on participant tolerability
|
Panel A (Healthy Participants): MK-8189 Monotherapy 24 mg
n=10 Participants
Healthy participants received MK-8189 monotherapy orally QD at a dose of 24 mg starting on Day 16 and continuing up to Day 18, based on participant tolerability
|
Panel A (Healthy Participants): Placebo Monotherapy
Healthy participants received MK-8189 monotherapy matching placebo orally QD on Days 1-18
|
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 4 mg
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 4 mg starting on Day 1 and continuing up to Day 3, based on participant tolerability
|
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 8 mg
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 8 mg starting on Day 4 and continuing up to Day 6, based on participant tolerability
|
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 12 mg
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 12 mg starting on Day 7 and continuing up to Day 9, based on participant tolerability
|
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 16 mg
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 16 mg starting on Day 10 and continuing up to Day 12, based on participant tolerability
|
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 20 mg
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 20 mg starting on Day 13 and continuing up to Day 15, based on participant tolerability
|
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 24 mg
n=10 Participants
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 24 mg starting on Day 16 and continuing up to Day 18, based on participant tolerability
|
Panel B (Schizophrenia Participants): Placebo Monotherapy
Participants with Schizophrenia received MK-8189 monotherapy matching placebo orally QD from Days 1-18.
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 4 mg
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 4 mg starting on Day 1 and continuing up to Day 3, based on participant tolerability
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 8 mg
In addition to background AAP treatment, participant with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 8 mg starting on Day 4 and continuing up to Day 11, based on participant tolerability
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 12 mg
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 12 mg starting on Day 7 and continuing up to Day 9, based on participant tolerability
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 16 mg
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 16 mg starting on Day 10 and continuing up to Day 12, based on participant tolerability
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 20 mg
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 20 mg starting on Day 13 and continuing up to Day 15, based on participant tolerability
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 24 mg
n=7 Participants
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 24 mg starting on Day 16 and continuing up to Day 18, based on participant tolerability
|
Panel C (Schizophrenia Participants): Placebo Add-on Therapy
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy matching placebo orally QD on Days 1-18
|
Panel D (Schizophrenia Participants): MK-8189 Monotherapy 8 mg
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 8 mg starting on Day 1 and continuing up to Day 3, based on participant tolerability
|
Panel D (Schizophrenia Participants): MK-8189 Monotherapy 16 mg
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 16 mg starting on Day 4 and continuing up to Day 6, based on participant tolerability
|
Panel D (Schizophrenia Participants): MK-8189 Monotherapy 24 mg
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 24 mg starting on Day 7 and continuing up to Day 9, based on participant tolerability
|
Panel D (Schizophrenia Participants): MK-8189 Monotherapy 36 mg
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 36 mg starting on Day 10 and continuing up to Day 12, based on participant tolerability
|
Panel D (Schizophrenia Participants): MK-8189 Monotherapy 48 mg
n=10 Participants
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 48 mg starting on Day 13 and continuing up to Day 15, based on participant tolerability
|
Panel D (Schizophrenia Participants): Placebo Monotherapy
Participants with Schizophrenia received MK-8189 monotherapy matching placebo orally QD on Days 1-15
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Volume of MK-8189 Distribution (Vd/F) on Day 18 (Panels A, B, C) and Day 15 (Panel D)
Day 15
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
47.1 Liter
Geometric Coefficient of Variation 48.0
|
—
|
|
Apparent Volume of MK-8189 Distribution (Vd/F) on Day 18 (Panels A, B, C) and Day 15 (Panel D)
Day 18
|
—
|
—
|
—
|
—
|
—
|
50.7 Liter
Geometric Coefficient of Variation 48.6
|
—
|
—
|
—
|
—
|
—
|
—
|
37.2 Liter
Geometric Coefficient of Variation 35.1
|
—
|
—
|
—
|
—
|
—
|
—
|
43.6 Liter
Geometric Coefficient of Variation 39.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 2, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose on Day 18 (Panel A, B, C) and Day 15 (Panel D)Population: All participants who got ≥1 dose of MK-8189, had t1/2 data for Day 18 (Panels A, B, C) or Day 15 (Panel D). Per protocol t1/2 was analyzed by panel, dose, dosing regimen; based on dosing, some arms weren't applicable to some timepoints, shown by 0 participants analyzed. The 4 mg, 8 mg, 12 mg, 16 mg, 20 mg (Panels A, B, C), 8 mg, 16 mg, 24 mg, 36 mg (Panel D) arms weren't applicable to the t1/2 timepoints; per protocol these arms and placebo arms were excluded.
t1/2 was the time required to divide the plasma concentration of MK-8189 by half after reaching pseudo-equilibrium. At least three quantifiable terminal phase concentrations collected were used to calculate t1/2. To estimate t1/2, per protocol blood samples were collected 2, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose on Day 18 for Panels A, B, C, and on Day 15 for Panel D. Per protocol t1/2 was analyzed by panel, dose and dosing regimen. Due to differing dosing regimen, some arms/doses weren't applicable to some timepoints, shown by 0 participants analyzed in the table. Per dosing regimen, the 4 mg, 8 mg, 12 mg, 16 mg, 20 mg (Panels A, B, C), 8 mg, 16 mg, 24 mg, 36 mg (Panel D) study arms weren't applicable to the protocol-specified timepoints/days of t1/2 analysis and were excluded. GCV was reported as a percent. Per protocol placebo arms were excluded from t1/2 analysis.
Outcome measures
| Measure |
Panel A (Healthy Participants): MK-8189 Monotherapy 4 mg
Healthy participants received MK-8189 monotherapy orally QD at a dose of 4 mg starting on Day 1 and continuing up to Day 3, based on participant tolerability
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Panel A (Healthy Participants): MK-8189 Monotherapy 8 mg
Healthy participants received MK-8189 monotherapy orally QD at a dose of 8 mg starting on Day 4 and continuing up to Day 6, based on participant tolerability
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Panel A (Healthy Participants): MK-8189 Monotherapy 12 mg
Healthy participants received MK-8189 monotherapy orally QD at a dose of 12 mg starting on Day 7 and continuing up to Day 9, based on participant tolerability
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Panel A (Healthy Participants): MK-8189 Monotherapy 16 mg
Healthy participants received MK-8189 monotherapy orally QD at a dose of 16 mg starting on Day 10 and continuing up to Day 12, based on participant tolerability
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Panel A (Healthy Participants): MK-8189 Monotherapy 20 mg
Healthy participants received MK-8189 monotherapy orally QD at a dose of 20 mg starting on Day 13 and continuing up to Day 15, based on participant tolerability
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Panel A (Healthy Participants): MK-8189 Monotherapy 24 mg
n=10 Participants
Healthy participants received MK-8189 monotherapy orally QD at a dose of 24 mg starting on Day 16 and continuing up to Day 18, based on participant tolerability
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Panel A (Healthy Participants): Placebo Monotherapy
Healthy participants received MK-8189 monotherapy matching placebo orally QD on Days 1-18
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Panel B (Schizophrenia Participants): MK-8189 Monotherapy 4 mg
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 4 mg starting on Day 1 and continuing up to Day 3, based on participant tolerability
|
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 8 mg
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 8 mg starting on Day 4 and continuing up to Day 6, based on participant tolerability
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Panel B (Schizophrenia Participants): MK-8189 Monotherapy 12 mg
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 12 mg starting on Day 7 and continuing up to Day 9, based on participant tolerability
|
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 16 mg
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 16 mg starting on Day 10 and continuing up to Day 12, based on participant tolerability
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Panel B (Schizophrenia Participants): MK-8189 Monotherapy 20 mg
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 20 mg starting on Day 13 and continuing up to Day 15, based on participant tolerability
|
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 24 mg
n=10 Participants
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 24 mg starting on Day 16 and continuing up to Day 18, based on participant tolerability
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Panel B (Schizophrenia Participants): Placebo Monotherapy
Participants with Schizophrenia received MK-8189 monotherapy matching placebo orally QD from Days 1-18.
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Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 4 mg
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 4 mg starting on Day 1 and continuing up to Day 3, based on participant tolerability
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Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 8 mg
In addition to background AAP treatment, participant with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 8 mg starting on Day 4 and continuing up to Day 11, based on participant tolerability
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 12 mg
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 12 mg starting on Day 7 and continuing up to Day 9, based on participant tolerability
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 16 mg
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 16 mg starting on Day 10 and continuing up to Day 12, based on participant tolerability
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 20 mg
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 20 mg starting on Day 13 and continuing up to Day 15, based on participant tolerability
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Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 24 mg
n=7 Participants
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 24 mg starting on Day 16 and continuing up to Day 18, based on participant tolerability
|
Panel C (Schizophrenia Participants): Placebo Add-on Therapy
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy matching placebo orally QD on Days 1-18
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Panel D (Schizophrenia Participants): MK-8189 Monotherapy 8 mg
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 8 mg starting on Day 1 and continuing up to Day 3, based on participant tolerability
|
Panel D (Schizophrenia Participants): MK-8189 Monotherapy 16 mg
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 16 mg starting on Day 4 and continuing up to Day 6, based on participant tolerability
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Panel D (Schizophrenia Participants): MK-8189 Monotherapy 24 mg
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 24 mg starting on Day 7 and continuing up to Day 9, based on participant tolerability
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Panel D (Schizophrenia Participants): MK-8189 Monotherapy 36 mg
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 36 mg starting on Day 10 and continuing up to Day 12, based on participant tolerability
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Panel D (Schizophrenia Participants): MK-8189 Monotherapy 48 mg
n=10 Participants
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 48 mg starting on Day 13 and continuing up to Day 15, based on participant tolerability
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Panel D (Schizophrenia Participants): Placebo Monotherapy
Participants with Schizophrenia received MK-8189 monotherapy matching placebo orally QD on Days 1-15
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Time Required for Plasma Concentration of MK-8189 to Decrease by Half (Apparent Terminal Half-life [t1/2]) on Day 18 (Panels A, B, C) and Day 15 (Panel D)
Day 15
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8.25 hr
Geometric Coefficient of Variation 20.0
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Time Required for Plasma Concentration of MK-8189 to Decrease by Half (Apparent Terminal Half-life [t1/2]) on Day 18 (Panels A, B, C) and Day 15 (Panel D)
Day 18
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7.60 hr
Geometric Coefficient of Variation 29.7
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10.9 hr
Geometric Coefficient of Variation 25.5
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9.10 hr
Geometric Coefficient of Variation 19.2
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Adverse Events
Panel A (Healthy Participants): MK-8189 Monotherapy 4 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Panel A (Healthy Participants): MK-8189 Monotherapy 8 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Panel A (Healthy Participants): MK-8189 Monotherapy 12 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Panel A (Healthy Participants): MK-8189 Monotherapy 16 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Panel A (Healthy Participants): MK-8189 Monotherapy 20 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Panel A (Healthy Participants): MK-8189 Monotherapy 24 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Panel A (Healthy Participants): Placebo Monotherapy
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 4 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 8 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 12 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 16 mg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 20 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 24 mg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Panel B (Schizophrenia Participants): Placebo Monotherapy
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 4 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 8 mg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 12 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 16 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 20 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 24 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Panel C (Schizophrenia Participants): Placebo Add-on Therapy
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Panel D (Schizophrenia Participants): MK-8189 Monotherapy 8 mg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Panel D (Schizophrenia Participants): MK-8189 Monotherapy 16 mg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Panel D (Schizophrenia Participants): MK-8189 Monotherapy 24 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Panel D (Schizophrenia Participants): MK-8189 Monotherapy 36 mg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Panel D (Schizophrenia Participants): MK-8189 Monotherapy 48 mg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Panel D (Schizophrenia Participants): Placebo Monotherapy
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Panel A (Healthy Participants): MK-8189 Monotherapy 4 mg
n=12 participants at risk
Healthy participants received MK-8189 monotherapy orally QD at a dose of 4 mg starting on Day 1 and continuing up to Day 3, based on participant tolerability
|
Panel A (Healthy Participants): MK-8189 Monotherapy 8 mg
n=12 participants at risk
Healthy participants received MK-8189 monotherapy orally QD at a dose of 8 mg starting on Day 4 and continuing up to Day 6, based on participant tolerability
|
Panel A (Healthy Participants): MK-8189 Monotherapy 12 mg
n=11 participants at risk
Healthy participants received MK-8189 monotherapy orally QD at a dose of 12 mg starting on Day 7 and continuing up to Day 9, based on participant tolerability
|
Panel A (Healthy Participants): MK-8189 Monotherapy 16 mg
n=11 participants at risk
Healthy participants received MK-8189 monotherapy orally QD at a dose of 16 mg starting on Day 10 and continuing up to Day 12, based on participant tolerability
|
Panel A (Healthy Participants): MK-8189 Monotherapy 20 mg
n=10 participants at risk
Healthy participants received MK-8189 monotherapy orally QD at a dose of 20 mg starting on Day 13 and continuing up to Day 15, based on participant tolerability
|
Panel A (Healthy Participants): MK-8189 Monotherapy 24 mg
n=10 participants at risk
Healthy participants received MK-8189 monotherapy orally QD at a dose of 24 mg starting on Day 16 and continuing up to Day 18, based on participant tolerability
|
Panel A (Healthy Participants): Placebo Monotherapy
n=4 participants at risk
Healthy participants received MK-8189 monotherapy matching placebo orally QD on Days 1-18
|
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 4 mg
n=12 participants at risk
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 4 mg starting on Day 1 and continuing up to Day 3, based on participant tolerability
|
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 8 mg
n=11 participants at risk
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 8 mg starting on Day 4 and continuing up to Day 6, based on participant tolerability
|
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 12 mg
n=11 participants at risk
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 12 mg starting on Day 7 and continuing up to Day 9, based on participant tolerability
|
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 16 mg
n=11 participants at risk
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 16 mg starting on Day 10 and continuing up to Day 12, based on participant tolerability
|
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 20 mg
n=10 participants at risk
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 20 mg starting on Day 13 and continuing up to Day 15, based on participant tolerability
|
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 24 mg
n=10 participants at risk
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 24 mg starting on Day 16 and continuing up to Day 18, based on participant tolerability
|
Panel B (Schizophrenia Participants): Placebo Monotherapy
n=4 participants at risk
Participants with Schizophrenia received MK-8189 monotherapy matching placebo orally QD on Days 1-18
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 4 mg
n=13 participants at risk
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 4 mg starting on Day 1 and continuing up to Day 3, based on participant tolerability
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 8 mg
n=11 participants at risk
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 8 mg starting on Day 4 and continuing up to Day 11, based on participant tolerability
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 12 mg
n=10 participants at risk
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 12 mg starting on Day 7 and continuing up to Day 9, based on participant tolerability
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 16 mg
n=8 participants at risk
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 16 mg starting on Day 10 and continuing up to Day 12, based on participant tolerability
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 20 mg
n=7 participants at risk
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 20 mg starting on Day 13 and continuing up to Day 15, based on participant tolerability
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 24 mg
n=7 participants at risk
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 24 mg starting on Day 16 and continuing up to Day 18, based on participant tolerability
|
Panel C (Schizophrenia Participants): Placebo Add-on Therapy
n=4 participants at risk
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy matching placebo orally QD on Days 1-18
|
Panel D (Schizophrenia Participants): MK-8189 Monotherapy 8 mg
n=17 participants at risk
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 8 mg starting on Day 1 and continuing up to Day 3, based on participant tolerability
|
Panel D (Schizophrenia Participants): MK-8189 Monotherapy 16 mg
n=16 participants at risk
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 16 mg starting on Day 4 and continuing up to Day 6, based on participant tolerability
|
Panel D (Schizophrenia Participants): MK-8189 Monotherapy 24 mg
n=15 participants at risk
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 24 mg starting on Day 7 and continuing up to Day 9, based on participant tolerability
|
Panel D (Schizophrenia Participants): MK-8189 Monotherapy 36 mg
n=13 participants at risk
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 36 mg starting on Day 10 and continuing up to Day 12, based on participant tolerability
|
Panel D (Schizophrenia Participants): MK-8189 Monotherapy 48 mg
n=11 participants at risk
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 48 mg starting on Day 13 and continuing up to Day 15, based on participant tolerability
|
Panel D (Schizophrenia Participants): Placebo Monotherapy
n=9 participants at risk
Participants with Schizophrenia received MK-8189 monotherapy matching placebo orally QD on Days 1-15
|
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Psychiatric disorders
Psychotic disorder
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
7.7%
1/13 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/9 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
Other adverse events
| Measure |
Panel A (Healthy Participants): MK-8189 Monotherapy 4 mg
n=12 participants at risk
Healthy participants received MK-8189 monotherapy orally QD at a dose of 4 mg starting on Day 1 and continuing up to Day 3, based on participant tolerability
|
Panel A (Healthy Participants): MK-8189 Monotherapy 8 mg
n=12 participants at risk
Healthy participants received MK-8189 monotherapy orally QD at a dose of 8 mg starting on Day 4 and continuing up to Day 6, based on participant tolerability
|
Panel A (Healthy Participants): MK-8189 Monotherapy 12 mg
n=11 participants at risk
Healthy participants received MK-8189 monotherapy orally QD at a dose of 12 mg starting on Day 7 and continuing up to Day 9, based on participant tolerability
|
Panel A (Healthy Participants): MK-8189 Monotherapy 16 mg
n=11 participants at risk
Healthy participants received MK-8189 monotherapy orally QD at a dose of 16 mg starting on Day 10 and continuing up to Day 12, based on participant tolerability
|
Panel A (Healthy Participants): MK-8189 Monotherapy 20 mg
n=10 participants at risk
Healthy participants received MK-8189 monotherapy orally QD at a dose of 20 mg starting on Day 13 and continuing up to Day 15, based on participant tolerability
|
Panel A (Healthy Participants): MK-8189 Monotherapy 24 mg
n=10 participants at risk
Healthy participants received MK-8189 monotherapy orally QD at a dose of 24 mg starting on Day 16 and continuing up to Day 18, based on participant tolerability
|
Panel A (Healthy Participants): Placebo Monotherapy
n=4 participants at risk
Healthy participants received MK-8189 monotherapy matching placebo orally QD on Days 1-18
|
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 4 mg
n=12 participants at risk
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 4 mg starting on Day 1 and continuing up to Day 3, based on participant tolerability
|
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 8 mg
n=11 participants at risk
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 8 mg starting on Day 4 and continuing up to Day 6, based on participant tolerability
|
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 12 mg
n=11 participants at risk
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 12 mg starting on Day 7 and continuing up to Day 9, based on participant tolerability
|
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 16 mg
n=11 participants at risk
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 16 mg starting on Day 10 and continuing up to Day 12, based on participant tolerability
|
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 20 mg
n=10 participants at risk
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 20 mg starting on Day 13 and continuing up to Day 15, based on participant tolerability
|
Panel B (Schizophrenia Participants): MK-8189 Monotherapy 24 mg
n=10 participants at risk
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 24 mg starting on Day 16 and continuing up to Day 18, based on participant tolerability
|
Panel B (Schizophrenia Participants): Placebo Monotherapy
n=4 participants at risk
Participants with Schizophrenia received MK-8189 monotherapy matching placebo orally QD on Days 1-18
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 4 mg
n=13 participants at risk
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 4 mg starting on Day 1 and continuing up to Day 3, based on participant tolerability
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 8 mg
n=11 participants at risk
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 8 mg starting on Day 4 and continuing up to Day 11, based on participant tolerability
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 12 mg
n=10 participants at risk
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 12 mg starting on Day 7 and continuing up to Day 9, based on participant tolerability
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 16 mg
n=8 participants at risk
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 16 mg starting on Day 10 and continuing up to Day 12, based on participant tolerability
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 20 mg
n=7 participants at risk
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 20 mg starting on Day 13 and continuing up to Day 15, based on participant tolerability
|
Panel C (Schizophrenia Participants): MK-8189 Add-on Therapy 24 mg
n=7 participants at risk
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy orally QD at a dose of 24 mg starting on Day 16 and continuing up to Day 18, based on participant tolerability
|
Panel C (Schizophrenia Participants): Placebo Add-on Therapy
n=4 participants at risk
In addition to background AAP treatment, participants with Schizophrenia received MK-8189 add-on therapy matching placebo orally QD on Days 1-18
|
Panel D (Schizophrenia Participants): MK-8189 Monotherapy 8 mg
n=17 participants at risk
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 8 mg starting on Day 1 and continuing up to Day 3, based on participant tolerability
|
Panel D (Schizophrenia Participants): MK-8189 Monotherapy 16 mg
n=16 participants at risk
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 16 mg starting on Day 4 and continuing up to Day 6, based on participant tolerability
|
Panel D (Schizophrenia Participants): MK-8189 Monotherapy 24 mg
n=15 participants at risk
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 24 mg starting on Day 7 and continuing up to Day 9, based on participant tolerability
|
Panel D (Schizophrenia Participants): MK-8189 Monotherapy 36 mg
n=13 participants at risk
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 36 mg starting on Day 10 and continuing up to Day 12, based on participant tolerability
|
Panel D (Schizophrenia Participants): MK-8189 Monotherapy 48 mg
n=11 participants at risk
Participants with Schizophrenia received MK-8189 monotherapy orally QD at a dose of 48 mg starting on Day 13 and continuing up to Day 15, based on participant tolerability
|
Panel D (Schizophrenia Participants): Placebo Monotherapy
n=9 participants at risk
Participants with Schizophrenia received MK-8189 monotherapy matching placebo orally QD on Days 1-15
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.7%
2/12 • Number of events 2 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
8.3%
1/12 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
25.0%
1/4 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
15.4%
2/13 • Number of events 2 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
18.2%
2/11 • Number of events 2 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
10.0%
1/10 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
14.3%
1/7 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
5.9%
1/17 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
7.7%
1/13 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/9 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
6.2%
1/16 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
11.1%
1/9 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
6.7%
1/15 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/9 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
6.2%
1/16 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/9 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
General disorders
Feeling of body temperature change
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
6.2%
1/16 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/9 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
11.1%
1/9 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Psychiatric disorders
Paranoia
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
12.5%
1/8 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
6.7%
1/15 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/9 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
9.1%
1/11 • Number of events 2 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
25.0%
1/4 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
6.2%
1/16 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
11.1%
1/9 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
9.1%
1/11 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
10.0%
1/10 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
9.1%
1/11 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
12.5%
1/8 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
6.2%
1/16 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/9 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Psychiatric disorders
Tic
|
8.3%
1/12 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/9 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Reproductive system and breast disorders
Breast tenderness
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
10.0%
1/10 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/9 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
9.1%
1/11 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
8.3%
1/12 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
9.1%
1/11 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
9.1%
1/11 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
22.2%
2/9 • Number of events 2 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
6.2%
1/16 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/9 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
9.1%
1/11 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
25.0%
1/4 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/9 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
7.7%
1/13 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/9 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
9.1%
1/11 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/9 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
11.1%
1/9 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
25.0%
1/4 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
9.1%
1/11 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/9 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
25.0%
1/4 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
25.0%
1/4 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
11.8%
2/17 • Number of events 2 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
33.3%
3/9 • Number of events 3 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
8.3%
1/12 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
25.0%
1/4 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/9 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
25.0%
1/4 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
7.7%
1/13 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/9 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
11.1%
1/9 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
6.2%
1/16 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/9 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
12.5%
1/8 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/9 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
12.5%
1/8 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
14.3%
1/7 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/9 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
11.1%
1/9 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
9.1%
1/11 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
10.0%
1/10 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
10.0%
1/10 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
7.7%
1/13 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
9.1%
1/11 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/9 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Cardiac disorders
Postural orthostatic tachycardia syndrome
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
14.3%
1/7 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/9 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Eye disorders
Asthenopia
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
11.1%
1/9 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Eye disorders
Eye irritation
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
14.3%
1/7 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/9 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
9.1%
1/11 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
10.0%
1/10 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
25.0%
1/4 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/9 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
11.1%
1/9 • Number of events 2 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
10.0%
1/10 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/9 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
25.0%
1/4 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
10.0%
1/10 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
7.7%
1/13 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
14.3%
1/7 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
9.1%
1/11 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/9 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
25.0%
1/4 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
27.3%
3/11 • Number of events 3 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
20.0%
2/10 • Number of events 2 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
25.0%
1/4 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
12.5%
1/8 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
14.3%
1/7 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
11.1%
1/9 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
10.0%
1/10 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
9.1%
1/11 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
25.0%
1/4 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
14.3%
1/7 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
11.1%
1/9 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
25.0%
1/4 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
25.0%
1/4 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
6.7%
1/15 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/9 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
8.3%
1/12 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
9.1%
1/11 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
10.0%
1/10 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
7.7%
1/13 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
14.3%
1/7 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
7.7%
1/13 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/9 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
10.0%
1/10 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/9 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
9.1%
1/11 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/9 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
7.7%
1/13 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/9 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
9.1%
1/11 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
10.0%
1/10 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
9.1%
1/11 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
10.0%
1/10 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
25.0%
1/4 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
9.1%
1/11 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
10.0%
1/10 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
14.3%
1/7 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
5.9%
1/17 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
6.2%
1/16 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
7.7%
1/13 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
18.2%
2/11 • Number of events 2 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
11.1%
1/9 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Tongue dry
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
9.1%
1/11 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/9 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
25.0%
1/4 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
9.1%
1/11 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
11.1%
1/9 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
10.0%
1/10 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
9.1%
1/11 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
9.1%
1/11 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
10.0%
1/10 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
14.3%
1/7 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
7.7%
1/13 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
9.1%
1/11 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/9 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
General disorders
Chest discomfort
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
10.0%
1/10 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
11.1%
1/9 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
General disorders
Chest pain
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
10.0%
1/10 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
10.0%
1/10 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
6.2%
1/16 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/9 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
General disorders
Fatigue
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
10.0%
1/10 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
25.0%
1/4 • Number of events 2 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
5.9%
1/17 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
6.2%
1/16 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/9 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
General disorders
Feeling hot
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
9.1%
1/11 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
14.3%
1/7 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/9 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
7.7%
1/13 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/9 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
10.0%
1/10 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/9 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
8.3%
1/12 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
25.0%
1/4 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/9 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
10.0%
1/10 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
10.0%
1/10 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/9 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Investigations
Blood pressure increased
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
10.0%
1/10 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/9 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Investigations
Orthostatic heart rate response increased
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
9.1%
1/11 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/9 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
25.0%
1/4 • Number of events 2 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
11.1%
1/9 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
8.3%
1/12 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
10.0%
1/10 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
25.0%
1/4 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
6.2%
1/16 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
13.3%
2/15 • Number of events 2 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
9.1%
1/11 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
22.2%
2/9 • Number of events 2 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
6.2%
1/16 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/9 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
10.0%
1/10 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
7.7%
1/13 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/9 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
9.1%
1/11 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/9 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
14.3%
1/7 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/9 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
9.1%
1/11 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
9.1%
1/11 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
9.1%
1/11 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/9 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
8.3%
1/12 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
18.2%
2/11 • Number of events 2 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
10.0%
1/10 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/9 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
9.1%
1/11 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
9.1%
1/11 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/9 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Nervous system disorders
Akathisia
|
8.3%
1/12 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
9.1%
1/11 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
7.7%
1/13 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
9.1%
1/11 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
5.9%
1/17 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/9 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Nervous system disorders
Dizziness
|
8.3%
1/12 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
9.1%
1/11 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
20.0%
2/10 • Number of events 2 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
9.1%
1/11 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
7.7%
1/13 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
18.2%
2/11 • Number of events 2 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
10.0%
1/10 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
25.0%
1/4 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
27.3%
3/11 • Number of events 3 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/9 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
9.1%
1/11 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/9 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Nervous system disorders
Dystonia
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
7.7%
1/13 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
9.1%
1/11 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
11.1%
1/9 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
14.3%
1/7 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/9 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
9.1%
1/11 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
11.1%
1/9 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
9.1%
1/11 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/9 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
18.2%
2/11 • Number of events 2 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
36.4%
4/11 • Number of events 4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
30.0%
3/10 • Number of events 3 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
25.0%
1/4 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
18.2%
2/11 • Number of events 2 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
18.2%
2/11 • Number of events 2 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
18.2%
2/11 • Number of events 2 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
10.0%
1/10 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
30.0%
3/10 • Number of events 4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
25.0%
1/4 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
18.2%
2/11 • Number of events 2 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
25.0%
2/8 • Number of events 2 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
5.9%
1/17 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
18.8%
3/16 • Number of events 3 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
13.3%
2/15 • Number of events 2 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
7.7%
1/13 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
22.2%
2/9 • Number of events 2 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
9.1%
1/11 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
11.1%
1/9 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Nervous system disorders
Parosmia
|
8.3%
1/12 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
14.3%
1/7 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/9 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
8.3%
1/12 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
10.0%
1/10 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
23.5%
4/17 • Number of events 4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
11.1%
1/9 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Nervous system disorders
Syncope
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
10.0%
1/10 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/9 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Nervous system disorders
Tremor
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
9.1%
1/11 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
14.3%
1/7 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
14.3%
1/7 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
9.1%
1/11 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/9 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Psychiatric disorders
Anxiety
|
8.3%
1/12 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
9.1%
1/11 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
25.0%
1/4 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
8.3%
1/12 • Number of events 2 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
30.0%
3/10 • Number of events 3 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
7.7%
1/13 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
10.0%
1/10 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
25.0%
4/16 • Number of events 4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
13.3%
2/15 • Number of events 2 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
18.2%
2/11 • Number of events 2 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
11.1%
1/9 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Psychiatric disorders
Dissociation
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
9.1%
1/11 • Number of events 2 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/9 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Psychiatric disorders
Insomnia
|
8.3%
1/12 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
20.0%
2/10 • Number of events 2 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
18.2%
2/11 • Number of events 2 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
25.0%
1/4 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
9.1%
1/11 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
25.0%
1/4 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
5.9%
1/17 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
7.7%
1/13 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
11.1%
1/9 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
6.7%
1/15 • Number of events 1 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/9 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/12 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
9.1%
1/11 • Number of events 2 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/10 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/8 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/7 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/4 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/17 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/16 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/15 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/13 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/11 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
0.00%
0/9 • Serious AEs, Non-serious AEs: Up to ~32 Days, All-cause mortality: Up to ~21 months
Safety was analyzed by panel and by dose, in all participants who received at least one dose of the study drug.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
- Publication restrictions are in place
Restriction type: OTHER