Trial Outcomes & Findings for MK-8189 Multiple Dose Study in Healthy Volunteers and Schizophrenia Participants (MK-8189-003) (NCT NCT02181803)
NCT ID: NCT02181803
Last Updated: 2020-03-27
Results Overview
C24hr was defined as the concentration of MK-8189 observed in plasma at the 24-hour nominal sampling time after administration of MK-8189. In participants receiving MK-8189, blood samples were collected pre-dose and 24 hours post-dose to estimate C24hr following MK-8189 administration. As specified by the protocol, C24hr was analyzed by part, dose and dosing schedule. Due to differing dosing schedules, some time points were not applicable for certain arms/doses as indicated by zero participants analyzed entered in the table. Per protocol, healthy participants (Part 3) and participants receiving placebo were excluded from C24 analysis.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
55 participants
Primary outcome timeframe
Day 1, 4, 8, 11 and 14 pre-dose and 24 hours post-dose
Results posted on
2020-03-27
Participant Flow
Forty-three schizophrenia participants and 12 healthy volunteers were randomized to either MK-8189 or placebo in Part 1 Panels A \& B, Part 2 Panel C, or Part 3 Panel D. MK-8189 dose and schedule were modified for participants based on tolerability.
Participant milestones
| Measure |
Part 1 Panel A & B MK-8189 Monotherapy 2-4 mg: Schizophrenic
Participant with Schizophrenia received monotherapy of MK-8189 in escalating doses: 2 mg once daily (QD) Days 1-4 and 4 mg QD Days 5-14
|
Part 1 Panel A & B MK-8189 Monotherapy 2-12 mg: Schizophrenic
Participants with Schizophrenia received monotherapy of MK-8189 in escalating doses: 2 mg QD Days 1-4, 4 mg QD Days 5-8, 8 mg QD Days 9-11, and 12 mg QD Days 12-14
|
Part 1 Panel A & B Placebo Monotherapy: Schizophrenic
Participants with Schizophrenia received dose-matched placebo to MK-8189 monotherapy on Days 1-14
|
Part 2 Panel C MK-8189 Add-on Therapy 2-12 mg: Schizophrenic
Participants with Schizophrenia received add-on therapy of MK-8189 in escalating doses: 2 mg QD Days 1-4, 4 mg QD Days 5-8, 8 mg QD Days 9-11, and 12 mg QD Days 12-14
|
Part 2 Panel C MK-8189 Add-on Therapy 4-16 mg: Schizophrenic
Participants with Schizophrenia received add-on therapy of MK-8189 in escalating doses: 4 mg QD Days 1-4, 8 mg QD Days 5-8, 12 mg QD Days 9-11, and 16 mg QD Days 12-14
|
Part 2 Panel C Placebo Add-on Therapy: Schizophrenic
Participants with Schizophrenia received dose-matched placebo to MK-8189 add-on therapy on Days 1-14
|
Part 3 Panel D MK-8189 Monotherapy 2-12 mg: Healthy
Healthy participants received monotherapy of MK-8189 in escalating doses: 2 mg QD Days 1-4, 4 mg QD Days 5-8, 8 mg QD Days 9-11, and 12 mg QD Days 12-14
|
Part 3 Panel D MK-8189 Monotherapy 2-8 mg: Healthy
Healthy participant received monotherapy of MK-8189 in escalating doses: 2 mg QD Days 1-4, 4 mg QD Days 5-8, and 8 mg QD days 9-14
|
Part 3 Panel D Placebo Monotherapy: Healthy
Healthy participants received dose-matched placebo to MK-8189 monotherapy on Days 1-14
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
13
|
4
|
13
|
6
|
6
|
9
|
1
|
2
|
|
Overall Study
COMPLETED
|
1
|
9
|
4
|
11
|
6
|
6
|
8
|
0
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
4
|
0
|
2
|
0
|
0
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
Part 1 Panel A & B MK-8189 Monotherapy 2-4 mg: Schizophrenic
Participant with Schizophrenia received monotherapy of MK-8189 in escalating doses: 2 mg once daily (QD) Days 1-4 and 4 mg QD Days 5-14
|
Part 1 Panel A & B MK-8189 Monotherapy 2-12 mg: Schizophrenic
Participants with Schizophrenia received monotherapy of MK-8189 in escalating doses: 2 mg QD Days 1-4, 4 mg QD Days 5-8, 8 mg QD Days 9-11, and 12 mg QD Days 12-14
|
Part 1 Panel A & B Placebo Monotherapy: Schizophrenic
Participants with Schizophrenia received dose-matched placebo to MK-8189 monotherapy on Days 1-14
|
Part 2 Panel C MK-8189 Add-on Therapy 2-12 mg: Schizophrenic
Participants with Schizophrenia received add-on therapy of MK-8189 in escalating doses: 2 mg QD Days 1-4, 4 mg QD Days 5-8, 8 mg QD Days 9-11, and 12 mg QD Days 12-14
|
Part 2 Panel C MK-8189 Add-on Therapy 4-16 mg: Schizophrenic
Participants with Schizophrenia received add-on therapy of MK-8189 in escalating doses: 4 mg QD Days 1-4, 8 mg QD Days 5-8, 12 mg QD Days 9-11, and 16 mg QD Days 12-14
|
Part 2 Panel C Placebo Add-on Therapy: Schizophrenic
Participants with Schizophrenia received dose-matched placebo to MK-8189 add-on therapy on Days 1-14
|
Part 3 Panel D MK-8189 Monotherapy 2-12 mg: Healthy
Healthy participants received monotherapy of MK-8189 in escalating doses: 2 mg QD Days 1-4, 4 mg QD Days 5-8, 8 mg QD Days 9-11, and 12 mg QD Days 12-14
|
Part 3 Panel D MK-8189 Monotherapy 2-8 mg: Healthy
Healthy participant received monotherapy of MK-8189 in escalating doses: 2 mg QD Days 1-4, 4 mg QD Days 5-8, and 8 mg QD days 9-14
|
Part 3 Panel D Placebo Monotherapy: Healthy
Healthy participants received dose-matched placebo to MK-8189 monotherapy on Days 1-14
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
2
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
MK-8189 Multiple Dose Study in Healthy Volunteers and Schizophrenia Participants (MK-8189-003)
Baseline characteristics by cohort
| Measure |
Part 1 Panel A & B MK-8189 Monotherapy 2-4 mg: Schizophrenic
n=1 Participants
Participant with Schizophrenia received monotherapy of MK-8189 in escalating doses: 2 mg once daily (QD) Days 1-4 and 4 mg QD Days 5-14
|
Part 1 Panel A & B MK-8189 Monotherapy 2-12 mg: Schizophrenic
n=13 Participants
Participants with Schizophrenia received monotherapy of MK-8189 in escalating doses: 2 mg QD Days 1-4, 4 mg QD Days 5-8, 8 mg QD Days 9-11, and 12 mg QD Days 12-14.
|
Part 1 Panel A & B Placebo Monotherapy: Schizophrenic
n=4 Participants
Participants with Schizophrenia received dose-matched placebo to MK-8189 monotherapy on Days 1-14
|
Part 2 Panel C MK-8189 Add-on Therapy 2-12 mg: Schizophrenic
n=13 Participants
Participants with Schizophrenia received add-on therapy of MK-8189 in escalating doses: 2 mg QD Days 1-4, 4 mg QD Days 5-8, 8 mg QD Days 9-11, and 12 mg QD Days 12-14
|
Part 2 Panel C MK-8189 Add-on Therapy 4-16 mg: Schizophrenic
n=6 Participants
Participants with Schizophrenia received add-on therapy of MK-8189 in escalating doses: 4 mg QD Days 1-4, 8 mg QD Days 5-8, 12 mg QD Days 9-11, and 16 mg QD Days 12-14
|
Part 2 Panel C Placebo Add-on Therapy: Schizophrenic
n=6 Participants
Participants with Schizophrenia received dose-matched placebo to MK-8189 add-on therapy on Days 1-14
|
Part 3 Panel D MK-8189 Monotherapy 2-12 mg: Healthy
n=9 Participants
Healthy participants received monotherapy of MK-8189 in escalating doses: 2 mg QD Days 1-4, 4 mg QD Days 5-8, 8 mg QD Days 9-11, and 12 mg QD Days 12-14
|
Part 3 Panel D MK-8189 Monotherapy 2-8 mg: Healthy
n=1 Participants
Healthy participant received monotherapy of MK-8189 in escalating doses: 2 mg QD Days 1-4, 4 mg QD Days 5-8, and 8 mg QD days 9-14
|
Part 3 Panel D Placebo Monotherapy: Healthy
n=2 Participants
Healthy participants received dose-matched placebo to MK-8189 monotherapy on Days 1-14
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
21.0 Years
STANDARD_DEVIATION NA • n=5 Participants
|
44.2 Years
STANDARD_DEVIATION 8.7 • n=7 Participants
|
44.0 Years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
43.8 Years
STANDARD_DEVIATION 8.9 • n=4 Participants
|
41.7 Years
STANDARD_DEVIATION 14.7 • n=21 Participants
|
44.5 Years
STANDARD_DEVIATION 7.6 • n=8 Participants
|
43.3 Years
STANDARD_DEVIATION 8.7 • n=8 Participants
|
55.0 Years
STANDARD_DEVIATION NA • n=24 Participants
|
43.0 Years
STANDARD_DEVIATION 5.7 • n=42 Participants
|
43.4 Years
STANDARD_DEVIATION 9.4 • n=42 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
17 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
38 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Day 1, 4, 8, 11 and 14 pre-dose and 24 hours post-dosePopulation: Schizophrenia participants who received ≥1 dose of MK-8189, complied with the protocol and had C24 data available for Days 1, 4, 8, 11, or 14. Due to differing dosing schedules, some time points were not applicable for some arms (shown by 0 participants analyzed). Per protocol, healthy participants (Part 3) and placebo arms were excluded.
C24hr was defined as the concentration of MK-8189 observed in plasma at the 24-hour nominal sampling time after administration of MK-8189. In participants receiving MK-8189, blood samples were collected pre-dose and 24 hours post-dose to estimate C24hr following MK-8189 administration. As specified by the protocol, C24hr was analyzed by part, dose and dosing schedule. Due to differing dosing schedules, some time points were not applicable for certain arms/doses as indicated by zero participants analyzed entered in the table. Per protocol, healthy participants (Part 3) and participants receiving placebo were excluded from C24 analysis.
Outcome measures
| Measure |
Part 1 Panel A & B MK-8189 Monotherapy 2 mg: Schizophrenic
n=13 Participants
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 2 mg QD starting on Day 1 and continuing up to Day 4, based on participant tolerability
|
Part 1 Panel A & B MK-8189 Monotherapy 4 mg: Schizophrenic
n=12 Participants
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 4 mg QD starting on Day 5 and continuing up to Day 14, based on participant tolerability
|
Part 1 Panel A & B MK-8189 Monotherapy 8 mg: Schizophrenic
n=10 Participants
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 8 mg QD starting on day 9 and continuing up to Day 11, based on participant tolerability
|
Part 1 Panel A & B MK-8189 Monotherapy 12 mg: Schizophrenic
n=9 Participants
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 12 mg QD starting on Day 12 and continuing up to Day 14, based on participant tolerability
|
Part 1 Panel A & B Placebo Monotherapy: Schizophrenic
Participants with Schizophrenia received dose-matched placebo to MK-8189 monotherapy on Days 1-14
|
Part 2 Panel C MK-8189 Add-on Therapy 2 mg: Schizophrenic
n=13 Participants
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 2 mg QD starting on Day 1 and continuing up to Day 4, based on participant tolerability
|
Part 2 Panel C MK-8189 Add-on Therapy 4 mg: Schizophrenic
n=11 Participants
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 4 mg QD starting on Day 1 and continuing up to Day 8, based on participant tolerability
|
Part 2 Panel C MK-8189 Add-on Therapy 8 mg: Schizophrenic
n=11 Participants
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 8 mg QD starting on Day 5 and continuing up to Day 11, based on participant tolerability
|
Part 2 Panel C MK-8189 Add-on Therapy 12 mg: Schizophrenic
n=11 Participants
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 12 mg QD starting on Day 9 and continuing up to Day 14, based on participant tolerability
|
Part 2 Panel C MK-8189 Add-on Therapy 16 mg: Schizophrenic
n=6 Participants
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 16 mg QD starting on Day 12 and continuing up to day 14, based on participant tolerability
|
Part 2 Panel C Placebo Add-on Therapy: Schizophrenic
Participants with Schizophrenia received dose-matched placebo to MK-8189 add-on therapy on Days 1-14
|
Part 3 Panel D MK-8189 Monotherapy 2 mg: Healthy
Healthy participants received monotherapy MK-8189 oral dose of 2 mg QD starting on Day 1 and continuing up to Day 4, based on participant tolerability
|
Part 3 Panel D MK-8189 Monotherapy 4 mg: Healthy
Healthy participants received monotherapy MK-8189 oral dose of 4 mg QD starting on Day 5 and continuing up to Day 8, based on participant tolerability
|
Part 3 Panel D MK-8189 Monotherapy 8 mg: Healthy
Healthy participants received monotherapy MK-8189 oral dose of 8 mg QD starting on Day 9 and continuing up to Day 14, based on participant tolerability
|
Part 3 Panel D MK-8189 Monotherapy 12 mg: Healthy
Healthy participants received monotherapy MK-8189 oral dose of 12 mg QD starting on Day 12 and continuing up to Day 14, based on participant tolerability
|
Part 3 Panel D Placebo Monotherapy: Healthy
Healthy participants received dose-matched placebo to MK-8189 monotherapy on Days 1-14
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Plasma Concentration at 24 Hours Post-dose (C24hr) of MK-8189 in Schizophrenia Participants
Day 1
|
67.0 nM
Geometric Coefficient of Variation 31.7
|
—
|
—
|
—
|
—
|
60.5 nM
Geometric Coefficient of Variation 37.1
|
161 nM
Geometric Coefficient of Variation 39.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Plasma Concentration at 24 Hours Post-dose (C24hr) of MK-8189 in Schizophrenia Participants
Day 4
|
81.1 nM
Geometric Coefficient of Variation 94.8
|
—
|
—
|
—
|
—
|
80.9 nM
Geometric Coefficient of Variation 49.1
|
242 nM
Geometric Coefficient of Variation 67.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Plasma Concentration at 24 Hours Post-dose (C24hr) of MK-8189 in Schizophrenia Participants
Day 8
|
—
|
183 nM
Geometric Coefficient of Variation 52.2
|
—
|
—
|
—
|
—
|
174 nM
Geometric Coefficient of Variation 39.4
|
419 nM
Geometric Coefficient of Variation 59.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Plasma Concentration at 24 Hours Post-dose (C24hr) of MK-8189 in Schizophrenia Participants
Day 11
|
—
|
148 nM
Geometric Coefficient of Variation NA
Measure of dispersion could not be estimated due to low number of participants analyzed
|
387 nM
Geometric Coefficient of Variation 42.0
|
—
|
—
|
—
|
—
|
321 nM
Geometric Coefficient of Variation 45.1
|
563 nM
Geometric Coefficient of Variation 72.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Plasma Concentration at 24 Hours Post-dose (C24hr) of MK-8189 in Schizophrenia Participants
Day 14
|
—
|
149 nM
Geometric Coefficient of Variation NA
Measure of dispersion could not be estimated due to low number of participants analyzed
|
—
|
459 nM
Geometric Coefficient of Variation 33.3
|
—
|
—
|
—
|
—
|
517 nM
Geometric Coefficient of Variation 52.0
|
655 nM
Geometric Coefficient of Variation 69.0
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and 2, 3, 4, 6, 8, 10, 12, 16, 24 hours post-dose; Days 4, 8, 11 pre-dose and 6, 10, 16, 24 hours post-dose; Day 14 pre-dose and 2, 3, 4, 6, 8, 10, 12, 16, 20, 24 hours post-dosePopulation: Schizophrenia participants who received ≥1 dose of MK-8189, complied with the protocol and had AUC(0-24hr) data available for Days 1, 4, 8, 11, or 14. Due to differing dosing schedules, some time points were not applicable for some arms (shown by 0 participants analyzed). Per protocol, healthy participants (Part 3) and placebo arms were excluded.
AUC was defined as a measure of MK-8189 exposure that was calculated as the product of plasma drug concentration and time. The linear-up-log down rule was used to estimate AUC. Blood samples were collected pre-dose and up to 24 hours post-dose to estimate AUC(0-24hr) following MK-8189 administration. As specified by the protocol, AUC(0-24hr) was analyzed by part, dose and dosing schedule. Due to differing dosing schedules, some time points were not applicable for certain arms/doses as indicated by zero participants analyzed entered in the table. Per protocol, healthy participants (Part 3) and participants receiving placebo were excluded from AUC(0-24hr) analysis.
Outcome measures
| Measure |
Part 1 Panel A & B MK-8189 Monotherapy 2 mg: Schizophrenic
n=13 Participants
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 2 mg QD starting on Day 1 and continuing up to Day 4, based on participant tolerability
|
Part 1 Panel A & B MK-8189 Monotherapy 4 mg: Schizophrenic
n=12 Participants
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 4 mg QD starting on Day 5 and continuing up to Day 14, based on participant tolerability
|
Part 1 Panel A & B MK-8189 Monotherapy 8 mg: Schizophrenic
n=10 Participants
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 8 mg QD starting on day 9 and continuing up to Day 11, based on participant tolerability
|
Part 1 Panel A & B MK-8189 Monotherapy 12 mg: Schizophrenic
n=9 Participants
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 12 mg QD starting on Day 12 and continuing up to Day 14, based on participant tolerability
|
Part 1 Panel A & B Placebo Monotherapy: Schizophrenic
Participants with Schizophrenia received dose-matched placebo to MK-8189 monotherapy on Days 1-14
|
Part 2 Panel C MK-8189 Add-on Therapy 2 mg: Schizophrenic
n=13 Participants
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 2 mg QD starting on Day 1 and continuing up to Day 4, based on participant tolerability
|
Part 2 Panel C MK-8189 Add-on Therapy 4 mg: Schizophrenic
n=11 Participants
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 4 mg QD starting on Day 1 and continuing up to Day 8, based on participant tolerability
|
Part 2 Panel C MK-8189 Add-on Therapy 8 mg: Schizophrenic
n=11 Participants
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 8 mg QD starting on Day 5 and continuing up to Day 11, based on participant tolerability
|
Part 2 Panel C MK-8189 Add-on Therapy 12 mg: Schizophrenic
n=11 Participants
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 12 mg QD starting on Day 9 and continuing up to Day 14, based on participant tolerability
|
Part 2 Panel C MK-8189 Add-on Therapy 16 mg: Schizophrenic
n=6 Participants
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 16 mg QD starting on Day 12 and continuing up to day 14, based on participant tolerability
|
Part 2 Panel C Placebo Add-on Therapy: Schizophrenic
Participants with Schizophrenia received dose-matched placebo to MK-8189 add-on therapy on Days 1-14
|
Part 3 Panel D MK-8189 Monotherapy 2 mg: Healthy
Healthy participants received monotherapy MK-8189 oral dose of 2 mg QD starting on Day 1 and continuing up to Day 4, based on participant tolerability
|
Part 3 Panel D MK-8189 Monotherapy 4 mg: Healthy
Healthy participants received monotherapy MK-8189 oral dose of 4 mg QD starting on Day 5 and continuing up to Day 8, based on participant tolerability
|
Part 3 Panel D MK-8189 Monotherapy 8 mg: Healthy
Healthy participants received monotherapy MK-8189 oral dose of 8 mg QD starting on Day 9 and continuing up to Day 14, based on participant tolerability
|
Part 3 Panel D MK-8189 Monotherapy 12 mg: Healthy
Healthy participants received monotherapy MK-8189 oral dose of 12 mg QD starting on Day 12 and continuing up to Day 14, based on participant tolerability
|
Part 3 Panel D Placebo Monotherapy: Healthy
Healthy participants received dose-matched placebo to MK-8189 monotherapy on Days 1-14
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma-concentration Curve at Zero to 24 Hours Post-dose (AUC[0-24hr]) of MK-8189 in Schizophrenia Participants
Day 1
|
1090 nM*hr
Geometric Coefficient of Variation 29.8
|
—
|
—
|
—
|
—
|
1040 nM*hr
Geometric Coefficient of Variation 27.3
|
2600 nM*hr
Geometric Coefficient of Variation 41.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Plasma-concentration Curve at Zero to 24 Hours Post-dose (AUC[0-24hr]) of MK-8189 in Schizophrenia Participants
Day 4
|
2160 nM*hr
Geometric Coefficient of Variation 69.6
|
—
|
—
|
—
|
—
|
1810 nM*hr
Geometric Coefficient of Variation 42.7
|
5740 nM*hr
Geometric Coefficient of Variation 57.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Plasma-concentration Curve at Zero to 24 Hours Post-dose (AUC[0-24hr]) of MK-8189 in Schizophrenia Participants
Day 8
|
—
|
4390 nM*hr
Geometric Coefficient of Variation 54.4
|
—
|
—
|
—
|
—
|
4300 nM*hr
Geometric Coefficient of Variation 31.5
|
10500 nM*hr
Geometric Coefficient of Variation 58.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Plasma-concentration Curve at Zero to 24 Hours Post-dose (AUC[0-24hr]) of MK-8189 in Schizophrenia Participants
Day 11
|
—
|
4720 nM*hr
Geometric Coefficient of Variation NA
Measure of dispersion could not be estimated due to low number of participants analyzed
|
9770 nM*hr
Geometric Coefficient of Variation 40.8
|
—
|
—
|
—
|
—
|
8540 nM*hr
Geometric Coefficient of Variation 31.2
|
14900 nM*hr
Geometric Coefficient of Variation 58.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Plasma-concentration Curve at Zero to 24 Hours Post-dose (AUC[0-24hr]) of MK-8189 in Schizophrenia Participants
Day 14
|
—
|
4100 nM*hr
Geometric Coefficient of Variation NA
Measure of dispersion could not be estimated due to low number of participants analyzed
|
—
|
12300 nM*hr
Geometric Coefficient of Variation 27.0
|
—
|
—
|
—
|
—
|
13200 nM*hr
Geometric Coefficient of Variation 38.5
|
18700 nM*hr
Geometric Coefficient of Variation 59.4
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and 2, 3, 4, 6, 8, 10, 12, 16, 24 hours post-dose; Days 4, 8, 11 pre-dose and 6, 10, 16, 24 hours post-dose; Day 14 pre-dose and 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 36, 48 hours post-dosePopulation: Schizophrenia participants who received ≥1 dose of MK-8189, complied with the protocol and had Cmax data available for Days 1, 4, 8, 11, or 14. Due to differing dosing schedules, some time points were not applicable for some arms (shown by 0 participants analyzed). Per protocol, healthy participants (Part 3) and placebo arms were excluded.
Cmax was defined as the maximum concentration of MK-8189 observed in plasma. Blood samples were collected pre-dose and up to 48 hours post-dose at multiple time points to estimate Cmax following MK-8189 administration. As specified by the protocol, Cmax was analyzed by part, dose and dosing schedule. Due to differing dosing schedules, some time points were not applicable for certain arms/doses as indicated by zero participants analyzed entered in the table. Per protocol, healthy participants (Part 3) and participants receiving placebo were excluded from Cmax analysis.
Outcome measures
| Measure |
Part 1 Panel A & B MK-8189 Monotherapy 2 mg: Schizophrenic
n=13 Participants
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 2 mg QD starting on Day 1 and continuing up to Day 4, based on participant tolerability
|
Part 1 Panel A & B MK-8189 Monotherapy 4 mg: Schizophrenic
n=12 Participants
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 4 mg QD starting on Day 5 and continuing up to Day 14, based on participant tolerability
|
Part 1 Panel A & B MK-8189 Monotherapy 8 mg: Schizophrenic
n=10 Participants
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 8 mg QD starting on day 9 and continuing up to Day 11, based on participant tolerability
|
Part 1 Panel A & B MK-8189 Monotherapy 12 mg: Schizophrenic
n=9 Participants
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 12 mg QD starting on Day 12 and continuing up to Day 14, based on participant tolerability
|
Part 1 Panel A & B Placebo Monotherapy: Schizophrenic
Participants with Schizophrenia received dose-matched placebo to MK-8189 monotherapy on Days 1-14
|
Part 2 Panel C MK-8189 Add-on Therapy 2 mg: Schizophrenic
n=13 Participants
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 2 mg QD starting on Day 1 and continuing up to Day 4, based on participant tolerability
|
Part 2 Panel C MK-8189 Add-on Therapy 4 mg: Schizophrenic
n=11 Participants
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 4 mg QD starting on Day 1 and continuing up to Day 8, based on participant tolerability
|
Part 2 Panel C MK-8189 Add-on Therapy 8 mg: Schizophrenic
n=11 Participants
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 8 mg QD starting on Day 5 and continuing up to Day 11, based on participant tolerability
|
Part 2 Panel C MK-8189 Add-on Therapy 12 mg: Schizophrenic
n=11 Participants
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 12 mg QD starting on Day 9 and continuing up to Day 14, based on participant tolerability
|
Part 2 Panel C MK-8189 Add-on Therapy 16 mg: Schizophrenic
n=6 Participants
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 16 mg QD starting on Day 12 and continuing up to day 14, based on participant tolerability
|
Part 2 Panel C Placebo Add-on Therapy: Schizophrenic
Participants with Schizophrenia received dose-matched placebo to MK-8189 add-on therapy on Days 1-14
|
Part 3 Panel D MK-8189 Monotherapy 2 mg: Healthy
Healthy participants received monotherapy MK-8189 oral dose of 2 mg QD starting on Day 1 and continuing up to Day 4, based on participant tolerability
|
Part 3 Panel D MK-8189 Monotherapy 4 mg: Healthy
Healthy participants received monotherapy MK-8189 oral dose of 4 mg QD starting on Day 5 and continuing up to Day 8, based on participant tolerability
|
Part 3 Panel D MK-8189 Monotherapy 8 mg: Healthy
Healthy participants received monotherapy MK-8189 oral dose of 8 mg QD starting on Day 9 and continuing up to Day 14, based on participant tolerability
|
Part 3 Panel D MK-8189 Monotherapy 12 mg: Healthy
Healthy participants received monotherapy MK-8189 oral dose of 12 mg QD starting on Day 12 and continuing up to Day 14, based on participant tolerability
|
Part 3 Panel D Placebo Monotherapy: Healthy
Healthy participants received dose-matched placebo to MK-8189 monotherapy on Days 1-14
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Post-dose Plasma Concentration (Cmax) of MK-8189 in Schizophrenia Participants
Day 1
|
70.7 nM
Geometric Coefficient of Variation 29.9
|
—
|
—
|
—
|
—
|
63.6 nM
Geometric Coefficient of Variation 27.5
|
165 nM
Geometric Coefficient of Variation 39.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Post-dose Plasma Concentration (Cmax) of MK-8189 in Schizophrenia Participants
Day 4
|
118 nM
Geometric Coefficient of Variation 60.7
|
—
|
—
|
—
|
—
|
90.6 nM
Geometric Coefficient of Variation 41.7
|
277 nM
Geometric Coefficient of Variation 59.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Post-dose Plasma Concentration (Cmax) of MK-8189 in Schizophrenia Participants
Day 8
|
—
|
212 nM
Geometric Coefficient of Variation 52.0
|
—
|
—
|
—
|
—
|
210 nM
Geometric Coefficient of Variation 29.8
|
518 nM
Geometric Coefficient of Variation 56.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Post-dose Plasma Concentration (Cmax) of MK-8189 in Schizophrenia Participants
Day 11
|
—
|
285 nM
Geometric Coefficient of Variation NA
Measure of dispersion could not be estimated due to low number of participants analyzed
|
472 nM
Geometric Coefficient of Variation 40.8
|
—
|
—
|
—
|
—
|
409 nM
Geometric Coefficient of Variation 28.8
|
718 nM
Geometric Coefficient of Variation 53.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Post-dose Plasma Concentration (Cmax) of MK-8189 in Schizophrenia Participants
Day 14
|
—
|
209 nM
Geometric Coefficient of Variation NA
Measure of dispersion could not be estimated due to low number of participants analyzed
|
—
|
628 nM
Geometric Coefficient of Variation 28.5
|
—
|
—
|
—
|
—
|
638 nM
Geometric Coefficient of Variation 34.8
|
1050 nM
Geometric Coefficient of Variation 46.3
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and 2, 3, 4, 6, 8, 10, 12, 16, 24 hours post-dose; Days 4, 8, 11 pre-dose and 6, 10, 16, 24 hours post-dose; Day 14 pre-dose and 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 36, 48 hours post-dosePopulation: Schizophrenia participants who received ≥1 dose of MK-8189, complied with the protocol and had Tmax data available for Days 1, 4, 8, 11, or 14. Due to differing dosing schedules, some time points were not applicable for some arms (shown by 0 participants analyzed). Per protocol, healthy participants (Part 3) and placebo arms were excluded.
Tmax was defined as the time required post dose to reach a maximum plasma concentration of MK-8189. It was estimated as the actual sampling time at the highest MK-8189 plasma concentration. Blood samples were collected pre-dose and up to 48 hours post-dose at multiple time points to estimate Tmax following MK-8189 administration. As specified by the protocol, Tmax was analyzed by part, dose and dosing schedule. Due to differing dosing schedules, some time points were not applicable for certain arms/doses as indicated by zero participants analyzed entered in the table. Per protocol, healthy participants (Part 3) and participants receiving placebo were excluded from Tmax analysis.
Outcome measures
| Measure |
Part 1 Panel A & B MK-8189 Monotherapy 2 mg: Schizophrenic
n=13 Participants
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 2 mg QD starting on Day 1 and continuing up to Day 4, based on participant tolerability
|
Part 1 Panel A & B MK-8189 Monotherapy 4 mg: Schizophrenic
n=12 Participants
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 4 mg QD starting on Day 5 and continuing up to Day 14, based on participant tolerability
|
Part 1 Panel A & B MK-8189 Monotherapy 8 mg: Schizophrenic
n=10 Participants
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 8 mg QD starting on day 9 and continuing up to Day 11, based on participant tolerability
|
Part 1 Panel A & B MK-8189 Monotherapy 12 mg: Schizophrenic
n=9 Participants
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 12 mg QD starting on Day 12 and continuing up to Day 14, based on participant tolerability
|
Part 1 Panel A & B Placebo Monotherapy: Schizophrenic
Participants with Schizophrenia received dose-matched placebo to MK-8189 monotherapy on Days 1-14
|
Part 2 Panel C MK-8189 Add-on Therapy 2 mg: Schizophrenic
n=13 Participants
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 2 mg QD starting on Day 1 and continuing up to Day 4, based on participant tolerability
|
Part 2 Panel C MK-8189 Add-on Therapy 4 mg: Schizophrenic
n=11 Participants
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 4 mg QD starting on Day 1 and continuing up to Day 8, based on participant tolerability
|
Part 2 Panel C MK-8189 Add-on Therapy 8 mg: Schizophrenic
n=11 Participants
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 8 mg QD starting on Day 5 and continuing up to Day 11, based on participant tolerability
|
Part 2 Panel C MK-8189 Add-on Therapy 12 mg: Schizophrenic
n=11 Participants
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 12 mg QD starting on Day 9 and continuing up to Day 14, based on participant tolerability
|
Part 2 Panel C MK-8189 Add-on Therapy 16 mg: Schizophrenic
n=6 Participants
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 16 mg QD starting on Day 12 and continuing up to day 14, based on participant tolerability
|
Part 2 Panel C Placebo Add-on Therapy: Schizophrenic
Participants with Schizophrenia received dose-matched placebo to MK-8189 add-on therapy on Days 1-14
|
Part 3 Panel D MK-8189 Monotherapy 2 mg: Healthy
Healthy participants received monotherapy MK-8189 oral dose of 2 mg QD starting on Day 1 and continuing up to Day 4, based on participant tolerability
|
Part 3 Panel D MK-8189 Monotherapy 4 mg: Healthy
Healthy participants received monotherapy MK-8189 oral dose of 4 mg QD starting on Day 5 and continuing up to Day 8, based on participant tolerability
|
Part 3 Panel D MK-8189 Monotherapy 8 mg: Healthy
Healthy participants received monotherapy MK-8189 oral dose of 8 mg QD starting on Day 9 and continuing up to Day 14, based on participant tolerability
|
Part 3 Panel D MK-8189 Monotherapy 12 mg: Healthy
Healthy participants received monotherapy MK-8189 oral dose of 12 mg QD starting on Day 12 and continuing up to Day 14, based on participant tolerability
|
Part 3 Panel D Placebo Monotherapy: Healthy
Healthy participants received dose-matched placebo to MK-8189 monotherapy on Days 1-14
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time Post-dose at Which the Maximum Plasma Concentration (Tmax) of MK-8189 Was Observed in Schizophrenia Participants
Day 1
|
20 hr
Interval 12.0 to 23.83
|
—
|
—
|
—
|
—
|
23.83 hr
Interval 10.1 to 25.27
|
23.83 hr
Interval 16.0 to 23.83
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time Post-dose at Which the Maximum Plasma Concentration (Tmax) of MK-8189 Was Observed in Schizophrenia Participants
Day 4
|
10 hr
Interval 0.0 to 23.87
|
—
|
—
|
—
|
—
|
23.83 hr
Interval 6.0 to 23.92
|
8 hr
Interval 0.0 to 23.83
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time Post-dose at Which the Maximum Plasma Concentration (Tmax) of MK-8189 Was Observed in Schizophrenia Participants
Day 8
|
—
|
10 hr
Interval 0.0 to 23.98
|
—
|
—
|
—
|
—
|
16 hr
Interval 0.0 to 23.83
|
0 hr
Interval 0.0 to 10.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time Post-dose at Which the Maximum Plasma Concentration (Tmax) of MK-8189 Was Observed in Schizophrenia Participants
Day 11
|
—
|
10 hr
Measure of dispersion could not be estimated due to low number of participants analyzed
|
10.03 hr
Interval 10.0 to 23.83
|
—
|
—
|
—
|
—
|
16 hr
Interval 0.0 to 23.83
|
16 hr
Interval 6.0 to 23.83
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time Post-dose at Which the Maximum Plasma Concentration (Tmax) of MK-8189 Was Observed in Schizophrenia Participants
Day 14
|
—
|
20 hr
Measure of dispersion could not be estimated due to low number of participants analyzed
|
—
|
16 hr
Interval 6.0 to 24.0
|
—
|
—
|
—
|
—
|
12 hr
Interval 4.0 to 20.0
|
8 hr
Interval 2.0 to 12.0
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 14 pre-dose and 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 36, 48 hours post-dosePopulation: Schizophrenia participants who received ≥1 dose of MK-8189, complied with the protocol and had t1/2 data available for Day 14. Due to differing dosing schedules, some time points were not applicable for some arms/doses (indicated by zero participants analyzed). Per protocol healthy participants (Part 3) and placebo arms were excluded.
t1/2 was defined as the time required to divide the MK-8189 plasma concentration by half after reaching pseudo-equilibrium. At least three quantifiable post-Cmax, terminal phase concentrations collected were used to calculate the apparent t1/2. Blood samples were collected pre-dose and up to 48 hours post-dose at multiple time points on Day 14 to estimate t1/2 following MK-8189 administration. As specified by the protocol, t1/2 was analyzed by part, dose and dosing schedule. Due to differing dosing schedules, the Day 14 timepoint was not applicable for certain arms/doses as indicated by zero participants analyzed entered in the table. Per protocol, healthy participants (Part 3) and participants receiving placebo were excluded from t1/2 analysis.
Outcome measures
| Measure |
Part 1 Panel A & B MK-8189 Monotherapy 2 mg: Schizophrenic
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 2 mg QD starting on Day 1 and continuing up to Day 4, based on participant tolerability
|
Part 1 Panel A & B MK-8189 Monotherapy 4 mg: Schizophrenic
n=1 Participants
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 4 mg QD starting on Day 5 and continuing up to Day 14, based on participant tolerability
|
Part 1 Panel A & B MK-8189 Monotherapy 8 mg: Schizophrenic
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 8 mg QD starting on day 9 and continuing up to Day 11, based on participant tolerability
|
Part 1 Panel A & B MK-8189 Monotherapy 12 mg: Schizophrenic
n=8 Participants
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 12 mg QD starting on Day 12 and continuing up to Day 14, based on participant tolerability
|
Part 1 Panel A & B Placebo Monotherapy: Schizophrenic
Participants with Schizophrenia received dose-matched placebo to MK-8189 monotherapy on Days 1-14
|
Part 2 Panel C MK-8189 Add-on Therapy 2 mg: Schizophrenic
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 2 mg QD starting on Day 1 and continuing up to Day 4, based on participant tolerability
|
Part 2 Panel C MK-8189 Add-on Therapy 4 mg: Schizophrenic
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 4 mg QD starting on Day 1 and continuing up to Day 8, based on participant tolerability
|
Part 2 Panel C MK-8189 Add-on Therapy 8 mg: Schizophrenic
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 8 mg QD starting on Day 5 and continuing up to Day 11, based on participant tolerability
|
Part 2 Panel C MK-8189 Add-on Therapy 12 mg: Schizophrenic
n=11 Participants
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 12 mg QD starting on Day 9 and continuing up to Day 14, based on participant tolerability
|
Part 2 Panel C MK-8189 Add-on Therapy 16 mg: Schizophrenic
n=6 Participants
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 16 mg QD starting on Day 12 and continuing up to day 14, based on participant tolerability
|
Part 2 Panel C Placebo Add-on Therapy: Schizophrenic
Participants with Schizophrenia received dose-matched placebo to MK-8189 add-on therapy on Days 1-14
|
Part 3 Panel D MK-8189 Monotherapy 2 mg: Healthy
Healthy participants received monotherapy MK-8189 oral dose of 2 mg QD starting on Day 1 and continuing up to Day 4, based on participant tolerability
|
Part 3 Panel D MK-8189 Monotherapy 4 mg: Healthy
Healthy participants received monotherapy MK-8189 oral dose of 4 mg QD starting on Day 5 and continuing up to Day 8, based on participant tolerability
|
Part 3 Panel D MK-8189 Monotherapy 8 mg: Healthy
Healthy participants received monotherapy MK-8189 oral dose of 8 mg QD starting on Day 9 and continuing up to Day 14, based on participant tolerability
|
Part 3 Panel D MK-8189 Monotherapy 12 mg: Healthy
Healthy participants received monotherapy MK-8189 oral dose of 12 mg QD starting on Day 12 and continuing up to Day 14, based on participant tolerability
|
Part 3 Panel D Placebo Monotherapy: Healthy
Healthy participants received dose-matched placebo to MK-8189 monotherapy on Days 1-14
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time Required for Plasma Concentration of MK-8189 to Decrease by Half (Apparent t1/2) in Schizophrenia Participants on Day 14
|
—
|
9.14 hr
Geometric Coefficient of Variation NA
Measure of dispersion could not be estimated due to low number of participants analyzed
|
—
|
8.38 hr
Geometric Coefficient of Variation 37.8
|
—
|
—
|
—
|
—
|
8.86 hr
Geometric Coefficient of Variation 37.4
|
10.4 hr
Geometric Coefficient of Variation 43.6
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 28Population: All participants who received as least one dose of the investigational drug. Per protocol, safety was assessed by part and dose.
An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The number of participants who experienced at least one AE were reported.
Outcome measures
| Measure |
Part 1 Panel A & B MK-8189 Monotherapy 2 mg: Schizophrenic
n=14 Participants
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 2 mg QD starting on Day 1 and continuing up to Day 4, based on participant tolerability
|
Part 1 Panel A & B MK-8189 Monotherapy 4 mg: Schizophrenic
n=12 Participants
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 4 mg QD starting on Day 5 and continuing up to Day 14, based on participant tolerability
|
Part 1 Panel A & B MK-8189 Monotherapy 8 mg: Schizophrenic
n=10 Participants
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 8 mg QD starting on day 9 and continuing up to Day 11, based on participant tolerability
|
Part 1 Panel A & B MK-8189 Monotherapy 12 mg: Schizophrenic
n=10 Participants
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 12 mg QD starting on Day 12 and continuing up to Day 14, based on participant tolerability
|
Part 1 Panel A & B Placebo Monotherapy: Schizophrenic
n=4 Participants
Participants with Schizophrenia received dose-matched placebo to MK-8189 monotherapy on Days 1-14
|
Part 2 Panel C MK-8189 Add-on Therapy 2 mg: Schizophrenic
n=13 Participants
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 2 mg QD starting on Day 1 and continuing up to Day 4, based on participant tolerability
|
Part 2 Panel C MK-8189 Add-on Therapy 4 mg: Schizophrenic
n=17 Participants
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 4 mg QD starting on Day 1 and continuing up to Day 8, based on participant tolerability
|
Part 2 Panel C MK-8189 Add-on Therapy 8 mg: Schizophrenic
n=17 Participants
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 8 mg QD starting on Day 5 and continuing up to Day 11, based on participant tolerability
|
Part 2 Panel C MK-8189 Add-on Therapy 12 mg: Schizophrenic
n=17 Participants
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 12 mg QD starting on Day 9 and continuing up to Day 14, based on participant tolerability
|
Part 2 Panel C MK-8189 Add-on Therapy 16 mg: Schizophrenic
n=6 Participants
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 16 mg QD starting on Day 12 and continuing up to day 14, based on participant tolerability
|
Part 2 Panel C Placebo Add-on Therapy: Schizophrenic
n=6 Participants
Participants with Schizophrenia received dose-matched placebo to MK-8189 add-on therapy on Days 1-14
|
Part 3 Panel D MK-8189 Monotherapy 2 mg: Healthy
n=10 Participants
Healthy participants received monotherapy MK-8189 oral dose of 2 mg QD starting on Day 1 and continuing up to Day 4, based on participant tolerability
|
Part 3 Panel D MK-8189 Monotherapy 4 mg: Healthy
n=10 Participants
Healthy participants received monotherapy MK-8189 oral dose of 4 mg QD starting on Day 5 and continuing up to Day 8, based on participant tolerability
|
Part 3 Panel D MK-8189 Monotherapy 8 mg: Healthy
n=10 Participants
Healthy participants received monotherapy MK-8189 oral dose of 8 mg QD starting on Day 9 and continuing up to Day 14, based on participant tolerability
|
Part 3 Panel D MK-8189 Monotherapy 12 mg: Healthy
n=9 Participants
Healthy participants received monotherapy MK-8189 oral dose of 12 mg QD starting on Day 12 and continuing up to Day 14, based on participant tolerability
|
Part 3 Panel D Placebo Monotherapy: Healthy
n=2 Participants
Healthy participants received dose-matched placebo to MK-8189 monotherapy on Days 1-14
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Experiencing an Adverse Event (AE)
|
8 Participants
|
6 Participants
|
2 Participants
|
6 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
7 Participants
|
7 Participants
|
2 Participants
|
4 Participants
|
5 Participants
|
5 Participants
|
6 Participants
|
3 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Up to Day 14Population: All participants who received as least one dose of the investigational drug. Per protocol, safety was assessed by part and dose.
An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The number of participants who discontinued study treatment due to an AE were reported.
Outcome measures
| Measure |
Part 1 Panel A & B MK-8189 Monotherapy 2 mg: Schizophrenic
n=14 Participants
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 2 mg QD starting on Day 1 and continuing up to Day 4, based on participant tolerability
|
Part 1 Panel A & B MK-8189 Monotherapy 4 mg: Schizophrenic
n=12 Participants
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 4 mg QD starting on Day 5 and continuing up to Day 14, based on participant tolerability
|
Part 1 Panel A & B MK-8189 Monotherapy 8 mg: Schizophrenic
n=10 Participants
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 8 mg QD starting on day 9 and continuing up to Day 11, based on participant tolerability
|
Part 1 Panel A & B MK-8189 Monotherapy 12 mg: Schizophrenic
n=10 Participants
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 12 mg QD starting on Day 12 and continuing up to Day 14, based on participant tolerability
|
Part 1 Panel A & B Placebo Monotherapy: Schizophrenic
n=4 Participants
Participants with Schizophrenia received dose-matched placebo to MK-8189 monotherapy on Days 1-14
|
Part 2 Panel C MK-8189 Add-on Therapy 2 mg: Schizophrenic
n=13 Participants
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 2 mg QD starting on Day 1 and continuing up to Day 4, based on participant tolerability
|
Part 2 Panel C MK-8189 Add-on Therapy 4 mg: Schizophrenic
n=17 Participants
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 4 mg QD starting on Day 1 and continuing up to Day 8, based on participant tolerability
|
Part 2 Panel C MK-8189 Add-on Therapy 8 mg: Schizophrenic
n=17 Participants
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 8 mg QD starting on Day 5 and continuing up to Day 11, based on participant tolerability
|
Part 2 Panel C MK-8189 Add-on Therapy 12 mg: Schizophrenic
n=17 Participants
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 12 mg QD starting on Day 9 and continuing up to Day 14, based on participant tolerability
|
Part 2 Panel C MK-8189 Add-on Therapy 16 mg: Schizophrenic
n=6 Participants
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 16 mg QD starting on Day 12 and continuing up to day 14, based on participant tolerability
|
Part 2 Panel C Placebo Add-on Therapy: Schizophrenic
n=6 Participants
Participants with Schizophrenia received dose-matched placebo to MK-8189 add-on therapy on Days 1-14
|
Part 3 Panel D MK-8189 Monotherapy 2 mg: Healthy
n=10 Participants
Healthy participants received monotherapy MK-8189 oral dose of 2 mg QD starting on Day 1 and continuing up to Day 4, based on participant tolerability
|
Part 3 Panel D MK-8189 Monotherapy 4 mg: Healthy
n=10 Participants
Healthy participants received monotherapy MK-8189 oral dose of 4 mg QD starting on Day 5 and continuing up to Day 8, based on participant tolerability
|
Part 3 Panel D MK-8189 Monotherapy 8 mg: Healthy
n=10 Participants
Healthy participants received monotherapy MK-8189 oral dose of 8 mg QD starting on Day 9 and continuing up to Day 14, based on participant tolerability
|
Part 3 Panel D MK-8189 Monotherapy 12 mg: Healthy
n=9 Participants
Healthy participants received monotherapy MK-8189 oral dose of 12 mg QD starting on Day 12 and continuing up to Day 14, based on participant tolerability
|
Part 3 Panel D Placebo Monotherapy: Healthy
n=2 Participants
Healthy participants received dose-matched placebo to MK-8189 monotherapy on Days 1-14
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Discontinue From Study Treatment Due to an AE
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and Day 13Population: Per protocol, MMN analyses were planned and executed in all Schizophrenia participants receiving MK-8189 monotherapy (irrespective of dosing schedule) with EEG electrode data available. Per protocol MK-8189 add-on therapy schizophrenia participants (Part 2), healthy participants (Part 3) and all placebo-treated participants were excluded.
MMN is a response to deviant tone (stimuli) measured in electroencephalogram (EEG) signals. Difference in deviant EEG waveform amplitude from standard amplitude over time indicates MMN; this difference at peak waveform is MMN peak amplitude. Schizophrenic participants show reduced response to deviant stimuli. Peak amplitude change from baseline (Day -1) to Day 13 was reported. A higher change indicates improved response to deviant stimuli. Scalp EEG signals were collected using a standard system array of 19 electrodes denoted by nomenclature of scalp placement: C3, C4, Cz, F3, F4, F7, F8, Fp1, Fp2, Fz, O1, O2, P3, P4, Pz, T3, T4, T5, T6. As specified by the protocol, MK-8189 add-on therapy schizophrenia participants (Part 2), healthy participants (Part 3) and all placebo-treated participants were excluded from MMN analyses. Per protocol, MMN analyses were planned and executed in all schizophrenia participants receiving MK-8189 monotherapy, irrespective of different dosing schedules.
Outcome measures
| Measure |
Part 1 Panel A & B MK-8189 Monotherapy 2 mg: Schizophrenic
n=11 Participants
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 2 mg QD starting on Day 1 and continuing up to Day 4, based on participant tolerability
|
Part 1 Panel A & B MK-8189 Monotherapy 4 mg: Schizophrenic
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 4 mg QD starting on Day 5 and continuing up to Day 14, based on participant tolerability
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Part 1 Panel A & B MK-8189 Monotherapy 8 mg: Schizophrenic
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 8 mg QD starting on day 9 and continuing up to Day 11, based on participant tolerability
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Part 1 Panel A & B MK-8189 Monotherapy 12 mg: Schizophrenic
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 12 mg QD starting on Day 12 and continuing up to Day 14, based on participant tolerability
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Part 1 Panel A & B Placebo Monotherapy: Schizophrenic
Participants with Schizophrenia received dose-matched placebo to MK-8189 monotherapy on Days 1-14
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Part 2 Panel C MK-8189 Add-on Therapy 2 mg: Schizophrenic
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 2 mg QD starting on Day 1 and continuing up to Day 4, based on participant tolerability
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Part 2 Panel C MK-8189 Add-on Therapy 4 mg: Schizophrenic
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 4 mg QD starting on Day 1 and continuing up to Day 8, based on participant tolerability
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Part 2 Panel C MK-8189 Add-on Therapy 8 mg: Schizophrenic
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 8 mg QD starting on Day 5 and continuing up to Day 11, based on participant tolerability
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Part 2 Panel C MK-8189 Add-on Therapy 12 mg: Schizophrenic
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 12 mg QD starting on Day 9 and continuing up to Day 14, based on participant tolerability
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Part 2 Panel C MK-8189 Add-on Therapy 16 mg: Schizophrenic
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 16 mg QD starting on Day 12 and continuing up to day 14, based on participant tolerability
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Part 2 Panel C Placebo Add-on Therapy: Schizophrenic
Participants with Schizophrenia received dose-matched placebo to MK-8189 add-on therapy on Days 1-14
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Part 3 Panel D MK-8189 Monotherapy 2 mg: Healthy
Healthy participants received monotherapy MK-8189 oral dose of 2 mg QD starting on Day 1 and continuing up to Day 4, based on participant tolerability
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Part 3 Panel D MK-8189 Monotherapy 4 mg: Healthy
Healthy participants received monotherapy MK-8189 oral dose of 4 mg QD starting on Day 5 and continuing up to Day 8, based on participant tolerability
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Part 3 Panel D MK-8189 Monotherapy 8 mg: Healthy
Healthy participants received monotherapy MK-8189 oral dose of 8 mg QD starting on Day 9 and continuing up to Day 14, based on participant tolerability
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Part 3 Panel D MK-8189 Monotherapy 12 mg: Healthy
Healthy participants received monotherapy MK-8189 oral dose of 12 mg QD starting on Day 12 and continuing up to Day 14, based on participant tolerability
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Part 3 Panel D Placebo Monotherapy: Healthy
Healthy participants received dose-matched placebo to MK-8189 monotherapy on Days 1-14
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Change From Baseline at Day 13 in Mismatched Negativity (MMN) Peak Amplitude in Monotherapy MK-8189-treated Schizophrenia Participants
C3
|
0.959 µV
Interval -0.218 to 2.137
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Change From Baseline at Day 13 in Mismatched Negativity (MMN) Peak Amplitude in Monotherapy MK-8189-treated Schizophrenia Participants
C4
|
0.812 µV
Interval -0.169 to 1.794
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Change From Baseline at Day 13 in Mismatched Negativity (MMN) Peak Amplitude in Monotherapy MK-8189-treated Schizophrenia Participants
Cz
|
1.170 µV
Interval -0.203 to 2.543
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Change From Baseline at Day 13 in Mismatched Negativity (MMN) Peak Amplitude in Monotherapy MK-8189-treated Schizophrenia Participants
F3
|
1.547 µV
Interval 0.171 to 2.922
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Change From Baseline at Day 13 in Mismatched Negativity (MMN) Peak Amplitude in Monotherapy MK-8189-treated Schizophrenia Participants
F4
|
1.240 µV
Interval -0.006 to 2.487
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Change From Baseline at Day 13 in Mismatched Negativity (MMN) Peak Amplitude in Monotherapy MK-8189-treated Schizophrenia Participants
F7
|
0.616 µV
Interval -0.471 to 1.702
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Change From Baseline at Day 13 in Mismatched Negativity (MMN) Peak Amplitude in Monotherapy MK-8189-treated Schizophrenia Participants
F8
|
0.488 µV
Interval -1.113 to 2.088
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Change From Baseline at Day 13 in Mismatched Negativity (MMN) Peak Amplitude in Monotherapy MK-8189-treated Schizophrenia Participants
Fp1
|
0.779 µV
Interval -0.586 to 2.144
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Change From Baseline at Day 13 in Mismatched Negativity (MMN) Peak Amplitude in Monotherapy MK-8189-treated Schizophrenia Participants
Fp2
|
1.103 µV
Interval -0.48 to 2.687
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Change From Baseline at Day 13 in Mismatched Negativity (MMN) Peak Amplitude in Monotherapy MK-8189-treated Schizophrenia Participants
Fz
|
1.462 µV
Interval 0.256 to 2.667
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Change From Baseline at Day 13 in Mismatched Negativity (MMN) Peak Amplitude in Monotherapy MK-8189-treated Schizophrenia Participants
O1
|
-0.099 µV
Interval -1.548 to 1.35
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Change From Baseline at Day 13 in Mismatched Negativity (MMN) Peak Amplitude in Monotherapy MK-8189-treated Schizophrenia Participants
O2
|
-0.014 µV
Interval -1.186 to 1.159
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Change From Baseline at Day 13 in Mismatched Negativity (MMN) Peak Amplitude in Monotherapy MK-8189-treated Schizophrenia Participants
P3
|
0.236 µV
Interval -1.188 to 1.66
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Change From Baseline at Day 13 in Mismatched Negativity (MMN) Peak Amplitude in Monotherapy MK-8189-treated Schizophrenia Participants
P4
|
-0.037 µV
Interval -1.233 to 1.159
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Change From Baseline at Day 13 in Mismatched Negativity (MMN) Peak Amplitude in Monotherapy MK-8189-treated Schizophrenia Participants
Pz
|
0.599 µV
Interval -0.675 to 1.873
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Change From Baseline at Day 13 in Mismatched Negativity (MMN) Peak Amplitude in Monotherapy MK-8189-treated Schizophrenia Participants
T3
|
1.018 µV
Interval -1.924 to 3.96
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Change From Baseline at Day 13 in Mismatched Negativity (MMN) Peak Amplitude in Monotherapy MK-8189-treated Schizophrenia Participants
T4
|
0.306 µV
Interval -2.667 to 3.278
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Change From Baseline at Day 13 in Mismatched Negativity (MMN) Peak Amplitude in Monotherapy MK-8189-treated Schizophrenia Participants
T5
|
-0.260 µV
Interval -3.475 to 2.955
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Change From Baseline at Day 13 in Mismatched Negativity (MMN) Peak Amplitude in Monotherapy MK-8189-treated Schizophrenia Participants
T6
|
0.178 µV
Interval -2.378 to 2.734
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SECONDARY outcome
Timeframe: Baseline and Day 13Population: Per protocol, MMN analyses were planned and executed in all Schizophrenia participants receiving MK-8189 monotherapy (irrespective of dosing schedule) with EEG electrode data available. Per protocol, MK-8189 add-on therapy schizophrenia participants (Part 2), healthy participants (Part 3), and all placebo-treated participants were excluded.
MMN is a response to deviant tone (stimuli) measured in EEG signals. Difference in deviant EEG waveform amplitude from standard amplitude over time indicates MMN; AUC was measured as the product of MMN amplitude and time. Schizophrenic participants show reduced response to deviant stimuli. AUC change from baseline (Day -1) to Day 13 was reported. A higher change indicates improved response to deviant stimuli. Scalp EEG signals were collected using a standard system array of 19 electrodes denoted by nomenclature of scalp placement: C3, C4, Cz, F3, F4, F7, F8, Fp1, Fp2, Fz, O1, O2, P3, P4, Pz, T3, T4, T5, T6. As specified by the protocol, MK-8189 add-on therapy schizophrenia participants (Part 2), healthy participants (Part 3), and all placebo-treated participants were excluded from MMN analyses. Per protocol, MMN analyses were planned and executed in all schizophrenia participants receiving MK-8189 monotherapy, irrespective of different dosing schedules.
Outcome measures
| Measure |
Part 1 Panel A & B MK-8189 Monotherapy 2 mg: Schizophrenic
n=11 Participants
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 2 mg QD starting on Day 1 and continuing up to Day 4, based on participant tolerability
|
Part 1 Panel A & B MK-8189 Monotherapy 4 mg: Schizophrenic
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 4 mg QD starting on Day 5 and continuing up to Day 14, based on participant tolerability
|
Part 1 Panel A & B MK-8189 Monotherapy 8 mg: Schizophrenic
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 8 mg QD starting on day 9 and continuing up to Day 11, based on participant tolerability
|
Part 1 Panel A & B MK-8189 Monotherapy 12 mg: Schizophrenic
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 12 mg QD starting on Day 12 and continuing up to Day 14, based on participant tolerability
|
Part 1 Panel A & B Placebo Monotherapy: Schizophrenic
Participants with Schizophrenia received dose-matched placebo to MK-8189 monotherapy on Days 1-14
|
Part 2 Panel C MK-8189 Add-on Therapy 2 mg: Schizophrenic
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 2 mg QD starting on Day 1 and continuing up to Day 4, based on participant tolerability
|
Part 2 Panel C MK-8189 Add-on Therapy 4 mg: Schizophrenic
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 4 mg QD starting on Day 1 and continuing up to Day 8, based on participant tolerability
|
Part 2 Panel C MK-8189 Add-on Therapy 8 mg: Schizophrenic
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 8 mg QD starting on Day 5 and continuing up to Day 11, based on participant tolerability
|
Part 2 Panel C MK-8189 Add-on Therapy 12 mg: Schizophrenic
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 12 mg QD starting on Day 9 and continuing up to Day 14, based on participant tolerability
|
Part 2 Panel C MK-8189 Add-on Therapy 16 mg: Schizophrenic
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 16 mg QD starting on Day 12 and continuing up to day 14, based on participant tolerability
|
Part 2 Panel C Placebo Add-on Therapy: Schizophrenic
Participants with Schizophrenia received dose-matched placebo to MK-8189 add-on therapy on Days 1-14
|
Part 3 Panel D MK-8189 Monotherapy 2 mg: Healthy
Healthy participants received monotherapy MK-8189 oral dose of 2 mg QD starting on Day 1 and continuing up to Day 4, based on participant tolerability
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Part 3 Panel D MK-8189 Monotherapy 4 mg: Healthy
Healthy participants received monotherapy MK-8189 oral dose of 4 mg QD starting on Day 5 and continuing up to Day 8, based on participant tolerability
|
Part 3 Panel D MK-8189 Monotherapy 8 mg: Healthy
Healthy participants received monotherapy MK-8189 oral dose of 8 mg QD starting on Day 9 and continuing up to Day 14, based on participant tolerability
|
Part 3 Panel D MK-8189 Monotherapy 12 mg: Healthy
Healthy participants received monotherapy MK-8189 oral dose of 12 mg QD starting on Day 12 and continuing up to Day 14, based on participant tolerability
|
Part 3 Panel D Placebo Monotherapy: Healthy
Healthy participants received dose-matched placebo to MK-8189 monotherapy on Days 1-14
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Change From Baseline at Day 13 in Mismatched Negativity (MMN) Area Under Curve (AUC) in Monotherapy MK-8189-treated Schizophrenia Participants
C3
|
-4.162 µV*msec
Interval -25.187 to 16.863
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Change From Baseline at Day 13 in Mismatched Negativity (MMN) Area Under Curve (AUC) in Monotherapy MK-8189-treated Schizophrenia Participants
C4
|
2.800 µV*msec
Interval -12.255 to 17.856
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Change From Baseline at Day 13 in Mismatched Negativity (MMN) Area Under Curve (AUC) in Monotherapy MK-8189-treated Schizophrenia Participants
Cz
|
2.813 µV*msec
Interval -19.664 to 25.29
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Change From Baseline at Day 13 in Mismatched Negativity (MMN) Area Under Curve (AUC) in Monotherapy MK-8189-treated Schizophrenia Participants
F3
|
6.277 µV*msec
Interval -12.012 to 24.565
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Change From Baseline at Day 13 in Mismatched Negativity (MMN) Area Under Curve (AUC) in Monotherapy MK-8189-treated Schizophrenia Participants
F4
|
9.814 µV*msec
Interval -5.671 to 25.299
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Change From Baseline at Day 13 in Mismatched Negativity (MMN) Area Under Curve (AUC) in Monotherapy MK-8189-treated Schizophrenia Participants
F7
|
-0.582 µV*msec
Interval -8.968 to 7.803
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Change From Baseline at Day 13 in Mismatched Negativity (MMN) Area Under Curve (AUC) in Monotherapy MK-8189-treated Schizophrenia Participants
F8
|
8.817 µV*msec
Interval -3.836 to 21.47
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Change From Baseline at Day 13 in Mismatched Negativity (MMN) Area Under Curve (AUC) in Monotherapy MK-8189-treated Schizophrenia Participants
Fp1
|
8.390 µV*msec
Interval -7.696 to 24.476
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Change From Baseline at Day 13 in Mismatched Negativity (MMN) Area Under Curve (AUC) in Monotherapy MK-8189-treated Schizophrenia Participants
Fp2
|
11.483 µV*msec
Interval -9.046 to 32.012
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Change From Baseline at Day 13 in Mismatched Negativity (MMN) Area Under Curve (AUC) in Monotherapy MK-8189-treated Schizophrenia Participants
Fz
|
7.880 µV*msec
Interval -14.368 to 30.129
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Change From Baseline at Day 13 in Mismatched Negativity (MMN) Area Under Curve (AUC) in Monotherapy MK-8189-treated Schizophrenia Participants
O1
|
-3.011 µV*msec
Interval -23.898 to 17.875
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Change From Baseline at Day 13 in Mismatched Negativity (MMN) Area Under Curve (AUC) in Monotherapy MK-8189-treated Schizophrenia Participants
O2
|
-10.261 µV*msec
Interval -24.94 to 4.419
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Change From Baseline at Day 13 in Mismatched Negativity (MMN) Area Under Curve (AUC) in Monotherapy MK-8189-treated Schizophrenia Participants
P3
|
-9.560 µV*msec
Interval -34.188 to 15.069
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Change From Baseline at Day 13 in Mismatched Negativity (MMN) Area Under Curve (AUC) in Monotherapy MK-8189-treated Schizophrenia Participants
P4
|
-9.154 µV*msec
Interval -29.863 to 11.555
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Change From Baseline at Day 13 in Mismatched Negativity (MMN) Area Under Curve (AUC) in Monotherapy MK-8189-treated Schizophrenia Participants
Pz
|
-10.019 µV*msec
Interval -36.607 to 16.57
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Change From Baseline at Day 13 in Mismatched Negativity (MMN) Area Under Curve (AUC) in Monotherapy MK-8189-treated Schizophrenia Participants
T3
|
-15.594 µV*msec
Interval -48.553 to 17.365
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Change From Baseline at Day 13 in Mismatched Negativity (MMN) Area Under Curve (AUC) in Monotherapy MK-8189-treated Schizophrenia Participants
T4
|
-3.341 µV*msec
Interval -23.264 to 16.582
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Change From Baseline at Day 13 in Mismatched Negativity (MMN) Area Under Curve (AUC) in Monotherapy MK-8189-treated Schizophrenia Participants
T5
|
-19.394 µV*msec
Interval -47.983 to 9.194
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Change From Baseline at Day 13 in Mismatched Negativity (MMN) Area Under Curve (AUC) in Monotherapy MK-8189-treated Schizophrenia Participants
T6
|
-12.686 µV*msec
Interval -39.17 to 13.799
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Adverse Events
Part 1 Panel A & B MK-8189 Monotherapy 2 mg: Schizophrenic
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Part 1 Panel A & B MK-8189 Monotherapy 4 mg: Schizophrenic
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part 1 Panel A & B MK-8189 Monotherapy 8 mg: Schizophrenic
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1 Panel A & B MK-8189 Monotherapy 12 mg: Schizophrenic
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part 1 Panel A & B Placebo Monotherapy: Schizophrenic
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1 Panel A & B Post Study: Schizophrenic
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 2 Panel C MK-8189 Add-on Therapy 2 mg: Schizophrenic
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 2 Panel C MK-8189 Add-on Therapy 4 mg: Schizophrenic
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part 2 Panel C MK-8189 Add-on Therapy 8 mg: Schizophrenic
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Part 2 Panel C MK-8189 Add-on Therapy 12 mg: Schizophrenic
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Part 2 Panel C MK-8189 Add-on Therapy 16 mg: Schizophrenic
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 2 Panel C Placebo Add-on Therapy: Schizophrenic
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part 2 Panel C Post Study: Schizophrenic
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 3 Panel D MK-8189 Monotherapy 2 mg: Healthy
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 3 Panel D MK-8189 Monotherapy 4 mg: Healthy
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 3 Panel D MK-8189 Monotherapy 8 mg: Healthy
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part 3 Panel D MK-8189 Monotherapy 12 mg: Healthy
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 3 Panel D Placebo Monotherapy: Healthy
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1 Panel D Post Study: Healthy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part 1 Panel A & B MK-8189 Monotherapy 2 mg: Schizophrenic
n=14 participants at risk
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 2 mg QD starting on Day 1 and continuing up to Day 4, based on participant tolerability
|
Part 1 Panel A & B MK-8189 Monotherapy 4 mg: Schizophrenic
n=12 participants at risk
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 4 mg QD starting on Day 5 and continuing up to Day 14, based on participant tolerability
|
Part 1 Panel A & B MK-8189 Monotherapy 8 mg: Schizophrenic
n=10 participants at risk
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 8 mg QD starting on day 9 and continuing up to Day 11, based on participant tolerability
|
Part 1 Panel A & B MK-8189 Monotherapy 12 mg: Schizophrenic
n=10 participants at risk
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 12 mg QD starting on Day 12 and continuing up to Day 14, based on participant tolerability
|
Part 1 Panel A & B Placebo Monotherapy: Schizophrenic
n=4 participants at risk
Participants with Schizophrenia received dose-matched placebo to MK-8189 monotherapy on Days 1-14
|
Part 1 Panel A & B Post Study: Schizophrenic
n=18 participants at risk
Participants with Schizophrenia who received monotherapy MK-8189 or matching placebo during the treatment period, were followed for safety during the post study period
|
Part 2 Panel C MK-8189 Add-on Therapy 2 mg: Schizophrenic
n=13 participants at risk
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 2 mg QD starting on Day 1 and continuing up to Day 4, based on participant tolerability
|
Part 2 Panel C MK-8189 Add-on Therapy 4 mg: Schizophrenic
n=17 participants at risk
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 4 mg QD starting on Day 1 and continuing up to Day 8, based on participant tolerability
|
Part 2 Panel C MK-8189 Add-on Therapy 8 mg: Schizophrenic
n=17 participants at risk
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 8 mg QD starting on Day 5 and continuing up to Day 11, based on participant tolerability
|
Part 2 Panel C MK-8189 Add-on Therapy 12 mg: Schizophrenic
n=17 participants at risk
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 12 mg QD starting on Day 9 and continuing up to Day 14, based on participant tolerability
|
Part 2 Panel C MK-8189 Add-on Therapy 16 mg: Schizophrenic
n=6 participants at risk
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 16 mg QD starting on Day 12 and continuing up to day 14, based on participant tolerability
|
Part 2 Panel C Placebo Add-on Therapy: Schizophrenic
n=6 participants at risk
Participants with Schizophrenia received dose-matched placebo to MK-8189 add-on therapy on Days 1-14
|
Part 2 Panel C Post Study: Schizophrenic
n=25 participants at risk
Participants with Schizophrenia who received add-on therapy MK-8189 or matching placebo during the treatment period, were followed for safety during the post study period
|
Part 3 Panel D MK-8189 Monotherapy 2 mg: Healthy
n=10 participants at risk
Healthy participants received monotherapy MK-8189 oral dose of 2 mg QD starting on Day 1 and continuing up to Day 4, based on participant tolerability
|
Part 3 Panel D MK-8189 Monotherapy 4 mg: Healthy
n=10 participants at risk
Healthy participants received monotherapy MK-8189 oral dose of 4 mg QD starting on Day 5 and continuing up to Day 8, based on participant tolerability
|
Part 3 Panel D MK-8189 Monotherapy 8 mg: Healthy
n=10 participants at risk
Healthy participants received monotherapy MK-8189 oral dose of 8 mg QD starting on Day 9 and continuing up to Day 14, based on participant tolerability
|
Part 3 Panel D MK-8189 Monotherapy 12 mg: Healthy
n=9 participants at risk
Healthy participants received monotherapy MK-8189 oral dose of 12 mg QD starting on Day 12 and continuing up to Day 14, based on participant tolerability
|
Part 3 Panel D Placebo Monotherapy: Healthy
n=2 participants at risk
Healthy participants received dose-matched placebo to MK-8189 monotherapy on Days 1-14
|
Part 1 Panel D Post Study: Healthy
n=12 participants at risk
Healthy participants who received monotherapy MK-8189 or matching placebo during the treatment period, were followed for safety during the post study period
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/14 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/4 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/13 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
11.1%
1/9 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
Other adverse events
| Measure |
Part 1 Panel A & B MK-8189 Monotherapy 2 mg: Schizophrenic
n=14 participants at risk
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 2 mg QD starting on Day 1 and continuing up to Day 4, based on participant tolerability
|
Part 1 Panel A & B MK-8189 Monotherapy 4 mg: Schizophrenic
n=12 participants at risk
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 4 mg QD starting on Day 5 and continuing up to Day 14, based on participant tolerability
|
Part 1 Panel A & B MK-8189 Monotherapy 8 mg: Schizophrenic
n=10 participants at risk
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 8 mg QD starting on day 9 and continuing up to Day 11, based on participant tolerability
|
Part 1 Panel A & B MK-8189 Monotherapy 12 mg: Schizophrenic
n=10 participants at risk
Participants with Schizophrenia received monotherapy MK-8189 oral dose of 12 mg QD starting on Day 12 and continuing up to Day 14, based on participant tolerability
|
Part 1 Panel A & B Placebo Monotherapy: Schizophrenic
n=4 participants at risk
Participants with Schizophrenia received dose-matched placebo to MK-8189 monotherapy on Days 1-14
|
Part 1 Panel A & B Post Study: Schizophrenic
n=18 participants at risk
Participants with Schizophrenia who received monotherapy MK-8189 or matching placebo during the treatment period, were followed for safety during the post study period
|
Part 2 Panel C MK-8189 Add-on Therapy 2 mg: Schizophrenic
n=13 participants at risk
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 2 mg QD starting on Day 1 and continuing up to Day 4, based on participant tolerability
|
Part 2 Panel C MK-8189 Add-on Therapy 4 mg: Schizophrenic
n=17 participants at risk
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 4 mg QD starting on Day 1 and continuing up to Day 8, based on participant tolerability
|
Part 2 Panel C MK-8189 Add-on Therapy 8 mg: Schizophrenic
n=17 participants at risk
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 8 mg QD starting on Day 5 and continuing up to Day 11, based on participant tolerability
|
Part 2 Panel C MK-8189 Add-on Therapy 12 mg: Schizophrenic
n=17 participants at risk
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 12 mg QD starting on Day 9 and continuing up to Day 14, based on participant tolerability
|
Part 2 Panel C MK-8189 Add-on Therapy 16 mg: Schizophrenic
n=6 participants at risk
Participants with Schizophrenia received add-on therapy MK-8189 oral dose of 16 mg QD starting on Day 12 and continuing up to day 14, based on participant tolerability
|
Part 2 Panel C Placebo Add-on Therapy: Schizophrenic
n=6 participants at risk
Participants with Schizophrenia received dose-matched placebo to MK-8189 add-on therapy on Days 1-14
|
Part 2 Panel C Post Study: Schizophrenic
n=25 participants at risk
Participants with Schizophrenia who received add-on therapy MK-8189 or matching placebo during the treatment period, were followed for safety during the post study period
|
Part 3 Panel D MK-8189 Monotherapy 2 mg: Healthy
n=10 participants at risk
Healthy participants received monotherapy MK-8189 oral dose of 2 mg QD starting on Day 1 and continuing up to Day 4, based on participant tolerability
|
Part 3 Panel D MK-8189 Monotherapy 4 mg: Healthy
n=10 participants at risk
Healthy participants received monotherapy MK-8189 oral dose of 4 mg QD starting on Day 5 and continuing up to Day 8, based on participant tolerability
|
Part 3 Panel D MK-8189 Monotherapy 8 mg: Healthy
n=10 participants at risk
Healthy participants received monotherapy MK-8189 oral dose of 8 mg QD starting on Day 9 and continuing up to Day 14, based on participant tolerability
|
Part 3 Panel D MK-8189 Monotherapy 12 mg: Healthy
n=9 participants at risk
Healthy participants received monotherapy MK-8189 oral dose of 12 mg QD starting on Day 12 and continuing up to Day 14, based on participant tolerability
|
Part 3 Panel D Placebo Monotherapy: Healthy
n=2 participants at risk
Healthy participants received dose-matched placebo to MK-8189 monotherapy on Days 1-14
|
Part 1 Panel D Post Study: Healthy
n=12 participants at risk
Healthy participants who received monotherapy MK-8189 or matching placebo during the treatment period, were followed for safety during the post study period
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/14 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
10.0%
1/10 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/4 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/13 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/9 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
|
Psychiatric disorders
Depersonalisation
|
0.00%
0/14 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/4 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/13 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
10.0%
1/10 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/9 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/14 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/4 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/13 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
16.7%
1/6 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/9 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/14 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
25.0%
1/4 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/13 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
10.0%
1/10 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/9 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/14 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
25.0%
1/4 • Number of events 2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/13 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/9 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/14 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/4 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/13 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
16.7%
1/6 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/9 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/14 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/4 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
7.7%
1/13 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/9 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/14 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
30.0%
3/10 • Number of events 3 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/4 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/13 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
5.9%
1/17 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
17.6%
3/17 • Number of events 3 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
11.1%
1/9 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/14 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/4 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
7.7%
1/13 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/9 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/14 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
8.3%
1/12 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
25.0%
1/4 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/13 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/9 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/14 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/4 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/13 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
5.9%
1/17 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/9 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
|
Gastrointestinal disorders
Nausea
|
7.1%
1/14 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
10.0%
1/10 • Number of events 2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/4 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/13 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
10.0%
1/10 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
10.0%
1/10 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
22.2%
2/9 • Number of events 2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/14 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/4 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/13 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
10.0%
1/10 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/9 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
|
Gastrointestinal disorders
Swollen tongue
|
7.1%
1/14 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/4 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/13 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/9 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
1/14 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
10.0%
1/10 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/4 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/13 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
5.9%
1/17 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
11.1%
1/9 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
|
General disorders
Chest pain
|
7.1%
1/14 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/4 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/13 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
4.0%
1/25 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
10.0%
1/10 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/9 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
|
General disorders
Fatigue
|
7.1%
1/14 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/4 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/13 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/9 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
|
General disorders
Feeling hot
|
0.00%
0/14 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/4 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/13 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
10.0%
1/10 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/9 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
|
General disorders
Feeling of body temperature change
|
0.00%
0/14 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/4 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/13 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
20.0%
2/10 • Number of events 2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/9 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
|
General disorders
Pyrexia
|
0.00%
0/14 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/4 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/13 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
16.7%
1/6 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/9 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/14 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
25.0%
1/4 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/13 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/9 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/14 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/4 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/13 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
11.1%
1/9 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/14 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/4 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/13 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
16.7%
1/6 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/9 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/14 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/4 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/13 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
5.9%
1/17 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/9 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/14 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
10.0%
1/10 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/4 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/13 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
5.9%
1/17 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/9 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
|
Psychiatric disorders
Derealisation
|
0.00%
0/14 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/4 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/13 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
10.0%
1/10 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/9 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/14 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/4 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
7.7%
1/13 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/9 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
21.4%
3/14 • Number of events 3 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
8.3%
1/12 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
10.0%
1/10 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
25.0%
1/4 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/13 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
16.7%
1/6 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/9 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/14 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/4 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/13 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
5.9%
1/17 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/9 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/14 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
25.0%
1/4 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/13 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/9 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/14 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/4 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/13 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
10.0%
1/10 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/9 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/14 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
10.0%
1/10 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/4 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/13 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/9 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/14 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
10.0%
1/10 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/4 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/13 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/9 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/14 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
10.0%
1/10 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/4 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/13 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
5.9%
1/17 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/9 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
|
Musculoskeletal and connective tissue disorders
Neck mass
|
0.00%
0/14 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
8.3%
1/12 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/4 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/13 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/9 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/14 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/4 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/13 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
5.9%
1/17 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/9 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
0.00%
0/14 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/4 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/13 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
16.7%
1/6 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/9 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
|
Nervous system disorders
Akathisia
|
0.00%
0/14 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
10.0%
1/10 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
10.0%
1/10 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
25.0%
1/4 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/13 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
5.9%
1/17 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
5.9%
1/17 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
5.9%
1/17 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
16.7%
1/6 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
10.0%
1/10 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/9 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/14 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/4 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/13 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
10.0%
1/10 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/9 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
|
Nervous system disorders
Disturbance in attention
|
7.1%
1/14 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/4 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/13 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/9 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
|
Nervous system disorders
Dizziness
|
7.1%
1/14 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
8.3%
1/12 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/4 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/13 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
16.7%
1/6 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
10.0%
1/10 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
11.1%
1/9 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/14 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/4 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/13 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
16.7%
1/6 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/9 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
|
Nervous system disorders
Dystonia
|
7.1%
1/14 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
8.3%
1/12 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/4 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/13 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/9 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/14 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/4 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/13 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
10.0%
1/10 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/9 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
|
Nervous system disorders
Headache
|
0.00%
0/14 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
8.3%
1/12 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
10.0%
1/10 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
10.0%
1/10 • Number of events 2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
25.0%
1/4 • Number of events 2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
7.7%
1/13 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
5.9%
1/17 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
5.9%
1/17 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
29.4%
5/17 • Number of events 6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
50.0%
3/6 • Number of events 3 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
10.0%
1/10 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
30.0%
3/10 • Number of events 3 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/9 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
|
Nervous system disorders
Muscle contractions involuntary
|
0.00%
0/14 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
25.0%
1/4 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/13 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/9 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
|
Nervous system disorders
Oromandibular dystonia
|
0.00%
0/14 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
8.3%
1/12 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/4 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/13 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
5.9%
1/17 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/9 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/14 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/4 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/13 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
10.0%
1/10 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/9 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
|
Nervous system disorders
Sleep paralysis
|
0.00%
0/14 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/4 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/13 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
10.0%
1/10 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/9 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
|
Nervous system disorders
Somnolence
|
7.1%
1/14 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
25.0%
1/4 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/13 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
23.5%
4/17 • Number of events 4 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
5.9%
1/17 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
5.9%
1/17 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
33.3%
2/6 • Number of events 2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
30.0%
3/10 • Number of events 3 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
30.0%
3/10 • Number of events 3 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/9 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
50.0%
1/2 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
|
Nervous system disorders
Spasmodic dysphonia
|
0.00%
0/14 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
10.0%
1/10 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/4 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/13 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/9 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
|
Nervous system disorders
Tremor
|
0.00%
0/14 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/4 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
7.7%
1/13 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
16.7%
1/6 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
11.1%
1/9 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/14 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/4 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/13 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
10.0%
1/10 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/9 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
|
Psychiatric disorders
Anhedonia
|
0.00%
0/14 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/4 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/13 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
10.0%
1/10 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/9 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/14 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
8.3%
1/12 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
25.0%
1/4 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/13 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
10.0%
1/10 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/9 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
|
Psychiatric disorders
Insomnia
|
7.1%
1/14 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
8.3%
1/12 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
25.0%
1/4 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/13 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
5.9%
1/17 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
10.0%
1/10 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
20.0%
2/10 • Number of events 2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/9 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/14 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/4 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/13 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
11.1%
1/9 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/14 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/4 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/13 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
16.7%
1/6 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/9 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.1%
1/14 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/4 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/13 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/9 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/14 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
25.0%
1/4 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/13 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/9 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/14 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
8.3%
1/12 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/4 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/13 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/9 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.3%
2/14 • Number of events 2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
25.0%
1/4 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/13 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/9 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/14 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
25.0%
1/4 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/13 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/9 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
50.0%
1/2 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/14 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
10.0%
1/10 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/4 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/13 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/9 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
|
Vascular disorders
Flushing
|
0.00%
0/14 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/4 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/13 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
5.9%
1/17 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/9 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
|
Vascular disorders
Hot flush
|
0.00%
0/14 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/4 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/13 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
11.1%
1/9 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
|
Vascular disorders
Orthostatic hypertension
|
0.00%
0/14 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
25.0%
1/4 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/13 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/9 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/14 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/4 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/18 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/13 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/17 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
5.9%
1/17 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/6 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/25 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/10 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
10.0%
1/10 • Number of events 1 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/9 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/2 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
0.00%
0/12 • Up to Day 28; all-cause mortality was assessed for up to ~9 months
Safety was assessed by part and dose, in all participants who received as least one dose of the investigational drug. Post Study AEs were pooled across the arms in each part of the study. AEs that occurred beyond 14 days of dosing were considered Post Study AEs.
|
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 Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
- Publication restrictions are in place
Restriction type: OTHER