Trial Outcomes & Findings for Study of the Safety and Efficacy of MK-8521 Compared to Placebo and a Diabetes Drug in Participants With Type 2 Diabetes Mellitus (MK-8521-003) (NCT NCT01982630)
NCT ID: NCT01982630
Last Updated: 2022-03-08
Results Overview
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. AEs are presented by individual dose received by participants during titration in an assigned study treatment sequence.
COMPLETED
PHASE1
87 participants
Up to approximately 42 days
2022-03-08
Participant Flow
This study had 2 parts: Part 1 evaluated MK-8521, placebo, and liraglutide in participants with Type 2 diabetes mellitus (T2DM); Part 2 evaluated MK-8521 at higher doses, liraglutide, and placebo in participants with T2DM and MK-8521 in non-diabetic, obese participants.
Participant flow, baseline characteristic, and outcome measure data are presented by study treatment sequence. Adverse events are presented by the individual doses contained in the study treatment sequence.
Participant milestones
| Measure |
Part 1: MK-8521 64/120 μg/Day
Type 2 diabetes mellitus (T2DM) participants received once daily subcutaneous MK-8521 starting at 64 μg on Days 1 to 7 and escalated to 120 μg on Days 8 to 14.
|
Part 1: MK-8521 34/72 μg/Day
T2DM participants received once daily subcutaneous MK-8521 starting at 34 μg on Days 1 to 7 and escalated to 72 μg on Days 8 to 14.
|
Part 1: Liraglutide 0.6/1.2/1.8 mg/Day
T2DM participants received once daily subcutaneous liraglutide starting at 0.6 mg on Day 1 and 2, escalated to 1.2 mg on Days 3 to 7, and escalated to 1.8 mg on Days 8 to 14.
|
Part 1: Placebo for MK-8521
T2DM participants received once daily subcutaneous placebo for MK-8521 for 14 days.
|
Part 2: MK-8521 64/120/180/240/300 µg/Day-T2DM
T2DM participants received once daily subcutaneous MK-8521 titrated to 300 µg starting at 64 µg and increasing to 120 µg on Day 8, 180 µg on Day 15, 240 µg on Day 20, and 300 µg on Day 25. The total number of dosing days was 29.
|
Part 2: Liraglutide 0.6/1.2/1.8 mg/Day-T2DM
T2DM participants received once daily subcutaneous liraglutide titrated to 1.8 mg starting at 0.6 mg and increasing to 1.2 mg on Day 8, and 1.8 mg on Day 15. The total number of dosing days was 29.
|
Part 2: Placebo for MK-8521-T2DM
T2DM participants received once daily subcutaneous placebo for MK-8521 for 29 days.
|
Part 2: MK-8521 64/120 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 titrated to 120 µg starting at 64 µg and increasing to 120 µg on Day 8. The total number of dosing days was 14.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
8
|
13
|
9
|
19
|
14
|
6
|
8
|
|
Overall Study
Treated
|
9
|
8
|
11
|
9
|
18
|
14
|
6
|
8
|
|
Overall Study
COMPLETED
|
7
|
8
|
8
|
8
|
16
|
11
|
5
|
8
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
5
|
1
|
3
|
3
|
1
|
0
|
Reasons for withdrawal
| Measure |
Part 1: MK-8521 64/120 μg/Day
Type 2 diabetes mellitus (T2DM) participants received once daily subcutaneous MK-8521 starting at 64 μg on Days 1 to 7 and escalated to 120 μg on Days 8 to 14.
|
Part 1: MK-8521 34/72 μg/Day
T2DM participants received once daily subcutaneous MK-8521 starting at 34 μg on Days 1 to 7 and escalated to 72 μg on Days 8 to 14.
|
Part 1: Liraglutide 0.6/1.2/1.8 mg/Day
T2DM participants received once daily subcutaneous liraglutide starting at 0.6 mg on Day 1 and 2, escalated to 1.2 mg on Days 3 to 7, and escalated to 1.8 mg on Days 8 to 14.
|
Part 1: Placebo for MK-8521
T2DM participants received once daily subcutaneous placebo for MK-8521 for 14 days.
|
Part 2: MK-8521 64/120/180/240/300 µg/Day-T2DM
T2DM participants received once daily subcutaneous MK-8521 titrated to 300 µg starting at 64 µg and increasing to 120 µg on Day 8, 180 µg on Day 15, 240 µg on Day 20, and 300 µg on Day 25. The total number of dosing days was 29.
|
Part 2: Liraglutide 0.6/1.2/1.8 mg/Day-T2DM
T2DM participants received once daily subcutaneous liraglutide titrated to 1.8 mg starting at 0.6 mg and increasing to 1.2 mg on Day 8, and 1.8 mg on Day 15. The total number of dosing days was 29.
|
Part 2: Placebo for MK-8521-T2DM
T2DM participants received once daily subcutaneous placebo for MK-8521 for 29 days.
|
Part 2: MK-8521 64/120 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 titrated to 120 µg starting at 64 µg and increasing to 120 µg on Day 8. The total number of dosing days was 14.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
1
|
0
|
1
|
2
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
2
|
1
|
2
|
0
|
0
|
0
|
|
Overall Study
Did Not Receive Drug-Technical Issues
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Study of the Safety and Efficacy of MK-8521 Compared to Placebo and a Diabetes Drug in Participants With Type 2 Diabetes Mellitus (MK-8521-003)
Baseline characteristics by cohort
| Measure |
Part 1: MK-8521 64/120 μg/Day
n=10 Participants
Type 2 diabetes mellitus (T2DM) participants received once daily subcutaneous MK-8521 starting at 64 μg on Days 1 to 7 and escalated to 120 μg on Days 8 to 14.
|
Part 1: MK-8521 34/72 μg/Day
n=8 Participants
T2DM participants received once daily subcutaneous MK-8521 starting at 34 μg on Days 1 to 7 and escalated to 72 μg on Days 8 to 14.
|
Part 1: Liraglutide 0.6/1.2/1.8 mg/Day
n=13 Participants
T2DM participants received once daily subcutaneous liraglutide starting at 0.6 mg on Day 1 and 2, escalated to 1.2 mg on Days 3 to 7, and escalated to 1.8 mg on Days 8 to 14.
|
Part 1: Placebo for MK-8521
n=9 Participants
T2DM participants received once daily subcutaneous placebo for MK-8521 for 14 days.
|
Part 2: MK-8521 64/120/180/240/300 µg/Day-T2DM
n=19 Participants
T2DM participants received once daily subcutaneous MK-8521 titrated to 300 µg starting at 64 µg and increasing to 120 µg on Day 8, 180 µg on Day 15, 240 µg on Day 20, and 300 µg on Day 25. The total number of dosing days was 29.
|
Part 2: Liraglutide 0.6/1.2/1.8 mg/Day-T2DM
n=14 Participants
T2DM participants received once daily subcutaneous liraglutide titrated to 1.8 mg starting at 0.6 mg and increasing to 1.2 mg on Day 8, and 1.8 mg on Day 15. The total number of dosing days was 29.
|
Part 2: Placebo for MK-8521-T2DM
n=6 Participants
T2DM participants received once daily subcutaneous placebo for MK-8521 for 29 days.
|
Part 2: MK-8521 64/120 µg/Day-Non-Diabetic Overweight/Obese
n=8 Participants
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 titrated to 120 µg starting at 64 µg and increasing to 120 µg on Day 8. The total number of dosing days was 14.
|
Total
n=87 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
52.1 Years
STANDARD_DEVIATION 8.6 • n=93 Participants
|
55.0 Years
STANDARD_DEVIATION 6.4 • n=4 Participants
|
54.5 Years
STANDARD_DEVIATION 8.8 • n=27 Participants
|
51.3 Years
STANDARD_DEVIATION 9.0 • n=483 Participants
|
54.6 Years
STANDARD_DEVIATION 6.0 • n=36 Participants
|
54.6 Years
STANDARD_DEVIATION 7.9 • n=10 Participants
|
52.8 Years
STANDARD_DEVIATION 6.9 • n=115 Participants
|
37.9 Years
STANDARD_DEVIATION 14.1 • n=40 Participants
|
52.3 Years
STANDARD_DEVIATION 9.4 • n=8 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
11 Participants
n=36 Participants
|
9 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
2 Participants
n=40 Participants
|
42 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
8 Participants
n=36 Participants
|
5 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
6 Participants
n=40 Participants
|
45 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
11 Participants
n=36 Participants
|
8 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
4 Participants
n=40 Participants
|
63 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
8 Participants
n=36 Participants
|
6 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
4 Participants
n=40 Participants
|
23 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
4 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
13 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
17 Participants
n=36 Participants
|
10 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
8 Participants
n=40 Participants
|
73 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 42 daysPopulation: The analysis population included all participants in Part 1 who received at least one dose of study drug.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. AEs are presented by individual dose received by participants during titration in an assigned study treatment sequence.
Outcome measures
| Measure |
Part 1: MK-8521 64 μg/Day
n=9 Participants
Type 2 Diabetes Mellitus (T2DM) participants received once daily subcutaneous MK-8521 64 μg/day on Days 1 to 7 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 120 μg/Day
n=7 Participants
T2DM participants received once daily subcutaneous MK-8521 120 μg/day on Days 8 to 14 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 34 μg/Day
n=8 Participants
T2DM participants received once daily subcutaneous MK-8521 34 μg/day on Days 1 to 7 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: MK-8521 72 μg/Day
n=8 Participants
T2DM participants received once daily subcutaneous MK-8521 72 μg/day on Days 8 to 14 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: Liraglutide 0.6 mg/Day
n=11 Participants
T2DM participants received once daily subcutaneous liraglutide 0.6 mg on Day 1 and 2 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.2 mg/Day
n=11 Participants
T2DM participants received once daily subcutaneous liraglutide 1.2 mg on Days 3 to 7 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.8 mg/Day
n=8 Participants
T2DM participants received once daily subcutaneous liraglutide 1.8 mg on Days 8 to 14 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Placebo for MK-8521
n=8 Participants
T2DM participants received once daily subcutaneous placebo for MK-8521 for 14 days.
|
Part 2: Placebo for MK-8521-T2DM
T2DM participants received once daily subcutaneous placebo for MK-8521 for 29 days.
|
Part 2: MK-8521 64 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 64 µg/day on Days 1 to 7 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
Part 2: MK-8521 120 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 120 µg/day hon Days 8 to 14 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Experiencing Adverse Events (AEs) in Part 1
|
5 Participants
|
5 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
7 Participants
|
2 Participants
|
5 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to approximately 57 daysPopulation: The analysis population included all participants in Part 2 who received at least one dose of study drug.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. AEs are presented by individual dose received by participants during titration in an assigned study treatment sequence.
Outcome measures
| Measure |
Part 1: MK-8521 64 μg/Day
n=18 Participants
Type 2 Diabetes Mellitus (T2DM) participants received once daily subcutaneous MK-8521 64 μg/day on Days 1 to 7 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 120 μg/Day
n=18 Participants
T2DM participants received once daily subcutaneous MK-8521 120 μg/day on Days 8 to 14 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 34 μg/Day
n=18 Participants
T2DM participants received once daily subcutaneous MK-8521 34 μg/day on Days 1 to 7 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: MK-8521 72 μg/Day
n=18 Participants
T2DM participants received once daily subcutaneous MK-8521 72 μg/day on Days 8 to 14 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: Liraglutide 0.6 mg/Day
n=15 Participants
T2DM participants received once daily subcutaneous liraglutide 0.6 mg on Day 1 and 2 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.2 mg/Day
n=14 Participants
T2DM participants received once daily subcutaneous liraglutide 1.2 mg on Days 3 to 7 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.8 mg/Day
n=13 Participants
T2DM participants received once daily subcutaneous liraglutide 1.8 mg on Days 8 to 14 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Placebo for MK-8521
n=13 Participants
T2DM participants received once daily subcutaneous placebo for MK-8521 for 14 days.
|
Part 2: Placebo for MK-8521-T2DM
n=6 Participants
T2DM participants received once daily subcutaneous placebo for MK-8521 for 29 days.
|
Part 2: MK-8521 64 µg/Day-Non-Diabetic Overweight/Obese
n=8 Participants
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 64 µg/day on Days 1 to 7 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
Part 2: MK-8521 120 µg/Day-Non-Diabetic Overweight/Obese
n=8 Participants
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 120 µg/day hon Days 8 to 14 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Experiencing Adverse Events (AEs) in Part 2
|
8 Participants
|
14 Participants
|
6 Participants
|
13 Participants
|
8 Participants
|
8 Participants
|
8 Participants
|
12 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 14 daysPopulation: The analysis population included all participants in Part 1 who received at least one dose of study drug.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. Discontinuations are presented by individual dose received by participants during titration in an assigned study treatment sequence.
Outcome measures
| Measure |
Part 1: MK-8521 64 μg/Day
n=9 Participants
Type 2 Diabetes Mellitus (T2DM) participants received once daily subcutaneous MK-8521 64 μg/day on Days 1 to 7 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 120 μg/Day
n=7 Participants
T2DM participants received once daily subcutaneous MK-8521 120 μg/day on Days 8 to 14 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 34 μg/Day
n=8 Participants
T2DM participants received once daily subcutaneous MK-8521 34 μg/day on Days 1 to 7 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: MK-8521 72 μg/Day
n=8 Participants
T2DM participants received once daily subcutaneous MK-8521 72 μg/day on Days 8 to 14 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: Liraglutide 0.6 mg/Day
n=11 Participants
T2DM participants received once daily subcutaneous liraglutide 0.6 mg on Day 1 and 2 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.2 mg/Day
n=11 Participants
T2DM participants received once daily subcutaneous liraglutide 1.2 mg on Days 3 to 7 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.8 mg/Day
n=8 Participants
T2DM participants received once daily subcutaneous liraglutide 1.8 mg on Days 8 to 14 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Placebo for MK-8521
n=8 Participants
T2DM participants received once daily subcutaneous placebo for MK-8521 for 14 days.
|
Part 2: Placebo for MK-8521-T2DM
T2DM participants received once daily subcutaneous placebo for MK-8521 for 29 days.
|
Part 2: MK-8521 64 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 64 µg/day on Days 1 to 7 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
Part 2: MK-8521 120 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 120 µg/day hon Days 8 to 14 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Discontinuing Study Drug Due to Adverse Events (AEs) in Part 1
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to approximately 29 daysPopulation: The analysis population included all participants in Part 2 who received at least one dose of study drug.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. Discontinuations are presented by individual dose received by participants during titration in an assigned study treatment sequence.
Outcome measures
| Measure |
Part 1: MK-8521 64 μg/Day
n=18 Participants
Type 2 Diabetes Mellitus (T2DM) participants received once daily subcutaneous MK-8521 64 μg/day on Days 1 to 7 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 120 μg/Day
n=18 Participants
T2DM participants received once daily subcutaneous MK-8521 120 μg/day on Days 8 to 14 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 34 μg/Day
n=18 Participants
T2DM participants received once daily subcutaneous MK-8521 34 μg/day on Days 1 to 7 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: MK-8521 72 μg/Day
n=18 Participants
T2DM participants received once daily subcutaneous MK-8521 72 μg/day on Days 8 to 14 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: Liraglutide 0.6 mg/Day
n=15 Participants
T2DM participants received once daily subcutaneous liraglutide 0.6 mg on Day 1 and 2 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.2 mg/Day
n=14 Participants
T2DM participants received once daily subcutaneous liraglutide 1.2 mg on Days 3 to 7 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.8 mg/Day
n=13 Participants
T2DM participants received once daily subcutaneous liraglutide 1.8 mg on Days 8 to 14 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Placebo for MK-8521
n=13 Participants
T2DM participants received once daily subcutaneous placebo for MK-8521 for 14 days.
|
Part 2: Placebo for MK-8521-T2DM
n=6 Participants
T2DM participants received once daily subcutaneous placebo for MK-8521 for 29 days.
|
Part 2: MK-8521 64 µg/Day-Non-Diabetic Overweight/Obese
n=8 Participants
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 64 µg/day on Days 1 to 7 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
Part 2: MK-8521 120 µg/Day-Non-Diabetic Overweight/Obese
n=8 Participants
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 120 µg/day hon Days 8 to 14 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Discontinuing Study Drug Due to Adverse Events (AEs) in Part 2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline (predose Day 1) and up to 24 hours post Day 7 dosePopulation: The analysis population included a subset of participants who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment according to the underlying scientific model and had data available for the analysis of the endpoint.
Semi-recumbent heart rate was assessed at baseline on Day 1; Day 7 at predose, 2, 4, 6, 8, 12, 13, 14, 15, 16, 22 hours postdose; and prior to dosing on Day 8. Heart rate was measured in triplicate with at least a 1-2-minute interval between measurements. The repeated measurements were averaged before conducting the statistical analysis. TWA0-24hr was calculated as the area under the measurement-time curve (AUC) divided by the time period of over which the measurements were made (i.e. 24 hrs.). Change from baseline TWA0-24hr HR was calculated as the TWA0-24hr HR at Day 7 minus baseline where baseline was defined as predose on Day 1.
Outcome measures
| Measure |
Part 1: MK-8521 64 μg/Day
n=6 Participants
Type 2 Diabetes Mellitus (T2DM) participants received once daily subcutaneous MK-8521 64 μg/day on Days 1 to 7 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 120 μg/Day
n=8 Participants
T2DM participants received once daily subcutaneous MK-8521 120 μg/day on Days 8 to 14 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 34 μg/Day
n=6 Participants
T2DM participants received once daily subcutaneous MK-8521 34 μg/day on Days 1 to 7 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: MK-8521 72 μg/Day
n=8 Participants
T2DM participants received once daily subcutaneous MK-8521 72 μg/day on Days 8 to 14 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: Liraglutide 0.6 mg/Day
T2DM participants received once daily subcutaneous liraglutide 0.6 mg on Day 1 and 2 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.2 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.2 mg on Days 3 to 7 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.8 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.8 mg on Days 8 to 14 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Placebo for MK-8521
T2DM participants received once daily subcutaneous placebo for MK-8521 for 14 days.
|
Part 2: Placebo for MK-8521-T2DM
T2DM participants received once daily subcutaneous placebo for MK-8521 for 29 days.
|
Part 2: MK-8521 64 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 64 µg/day on Days 1 to 7 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
Part 2: MK-8521 120 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 120 µg/day hon Days 8 to 14 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Time-weighted Average From 0 to 24 Hours (TWA0-24hr) of Heart Rate (HR) After 7 Days of Treatment in Type 2 Diabetes Mellitus (T2DM) Participants in Part 1
|
7.19 Beats per minute
Interval 3.48 to 10.89
|
1.17 Beats per minute
Interval -2.21 to 4.55
|
7.42 Beats per minute
Interval 3.74 to 11.09
|
5.69 Beats per minute
Interval 2.39 to 8.99
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (predose Day 1) and up to 24 hours post Day 7 dosePopulation: The analysis population included a subset of participants who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment according to the underlying scientific model and had data available for the analysis of the endpoint. Per-protocol, non-diabetic overweight/obese participants were not planned for the TWA0-24hr analysis of heart rate.
Semi-recumbent HR was measured in triplicate with at least a 1-2-minute interval between measurements at the following time points: baseline on Day 1; Day 7: predose, 2, 4, 6, 8, 12, and 16 hours postdose; and prior to dosing on Day 8. The repeated measurements were averaged before conducting the analysis. TWA0-24hr was calculated as the AUC divided by the time period of over which the measurements were made (i.e. 24 hrs.). Change from baseline TWA0-24hr HR was calculated as the TWA0-24hr HR at Day 7 minus baseline where baseline was defined as predose on Day 1.
Outcome measures
| Measure |
Part 1: MK-8521 64 μg/Day
n=18 Participants
Type 2 Diabetes Mellitus (T2DM) participants received once daily subcutaneous MK-8521 64 μg/day on Days 1 to 7 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 120 μg/Day
n=13 Participants
T2DM participants received once daily subcutaneous MK-8521 120 μg/day on Days 8 to 14 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 34 μg/Day
n=6 Participants
T2DM participants received once daily subcutaneous MK-8521 34 μg/day on Days 1 to 7 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: MK-8521 72 μg/Day
T2DM participants received once daily subcutaneous MK-8521 72 μg/day on Days 8 to 14 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: Liraglutide 0.6 mg/Day
T2DM participants received once daily subcutaneous liraglutide 0.6 mg on Day 1 and 2 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.2 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.2 mg on Days 3 to 7 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.8 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.8 mg on Days 8 to 14 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Placebo for MK-8521
T2DM participants received once daily subcutaneous placebo for MK-8521 for 14 days.
|
Part 2: Placebo for MK-8521-T2DM
T2DM participants received once daily subcutaneous placebo for MK-8521 for 29 days.
|
Part 2: MK-8521 64 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 64 µg/day on Days 1 to 7 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
Part 2: MK-8521 120 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 120 µg/day hon Days 8 to 14 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Time-weighted Average From 0 to 24 Hours (TWA0-24hr) of Heart Rate (HR) After 7 Days of Treatment in Type 2 Diabetes Mellitus (T2DM) Participants in Part 2
|
1.99 Beats per minute
Interval 0.1 to 3.88
|
4.10 Beats per minute
Interval 1.87 to 6.34
|
-0.54 Beats per minute
Interval -3.8 to 2.73
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (predose Day 1) and up to 24 hours post Day 14 dosePopulation: The analysis population included a subset of participants who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment according to the underlying scientific model and had data available for the analysis of the endpoint.
Semi-recumbent HR was measured in triplicate with at least a 1-2-minute interval between measurements at the following time points: baseline on Day 1; Day 14: predose, 2, 4, 6, 8, 12, 13, 14, 15, 16, 22 hours postdose and prior to dosing on Day 15. The repeated measurements were averaged before conducting the analysis. TWA0-24hr was calculated as the AUC divided by the time period of over which the measurements were made (i.e. 24 hrs.). Change from baseline TWA0-24hr HR was calculated as the TWA0-24hr HR at Day 14 minus baseline where baseline was defined as predose on Day 1.
Outcome measures
| Measure |
Part 1: MK-8521 64 μg/Day
n=6 Participants
Type 2 Diabetes Mellitus (T2DM) participants received once daily subcutaneous MK-8521 64 μg/day on Days 1 to 7 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 120 μg/Day
n=8 Participants
T2DM participants received once daily subcutaneous MK-8521 120 μg/day on Days 8 to 14 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 34 μg/Day
n=6 Participants
T2DM participants received once daily subcutaneous MK-8521 34 μg/day on Days 1 to 7 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: MK-8521 72 μg/Day
n=8 Participants
T2DM participants received once daily subcutaneous MK-8521 72 μg/day on Days 8 to 14 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: Liraglutide 0.6 mg/Day
T2DM participants received once daily subcutaneous liraglutide 0.6 mg on Day 1 and 2 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.2 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.2 mg on Days 3 to 7 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.8 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.8 mg on Days 8 to 14 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Placebo for MK-8521
T2DM participants received once daily subcutaneous placebo for MK-8521 for 14 days.
|
Part 2: Placebo for MK-8521-T2DM
T2DM participants received once daily subcutaneous placebo for MK-8521 for 29 days.
|
Part 2: MK-8521 64 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 64 µg/day on Days 1 to 7 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
Part 2: MK-8521 120 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 120 µg/day hon Days 8 to 14 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Time-weighted Average From 0 to 24 Hours (TWA0-24hr) of Heart Rate (HR) After 14 Days of Treatment in Type 2 Diabetes Mellitus (T2DM) Participants in Part 1
|
9.67 Beats per minute
Interval 5.97 to 13.37
|
3.90 Beats per minute
Interval 0.52 to 7.28
|
10.32 Beats per minute
Interval 6.65 to 14.0
|
9.81 Beats per minute
Interval 6.51 to 13.12
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (predose Day 1) and up to 24 hours post Day 14 dosePopulation: The analysis population included a subset of participants who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment according to the underlying scientific model and had data available for the analysis of the endpoint. Per-protocol, non-diabetic overweight/obese participants were not planned for the TWA0-24hr analysis of heart rate.
Semi-recumbent HR was measured in triplicate with at least a 1-2-minute interval between measurements at the following time points: baseline on Day 1; Day 14: predose, 2, 4, 6, 8, 12, 16, hours postdose; and prior to dosing on Day 15. The repeated measurements were averaged before conducting the analysis. TWA0-24hr was calculated as the AUC divided by the time period of over which the measurements were made (i.e. 24 hrs.). Change from baseline TWA0-24hr HR was calculated as the TWA0-24hr HR at Day 14 minus baseline where baseline was defined as predose on Day 1.
Outcome measures
| Measure |
Part 1: MK-8521 64 μg/Day
n=18 Participants
Type 2 Diabetes Mellitus (T2DM) participants received once daily subcutaneous MK-8521 64 μg/day on Days 1 to 7 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 120 μg/Day
n=13 Participants
T2DM participants received once daily subcutaneous MK-8521 120 μg/day on Days 8 to 14 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 34 μg/Day
n=5 Participants
T2DM participants received once daily subcutaneous MK-8521 34 μg/day on Days 1 to 7 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: MK-8521 72 μg/Day
T2DM participants received once daily subcutaneous MK-8521 72 μg/day on Days 8 to 14 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: Liraglutide 0.6 mg/Day
T2DM participants received once daily subcutaneous liraglutide 0.6 mg on Day 1 and 2 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.2 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.2 mg on Days 3 to 7 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.8 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.8 mg on Days 8 to 14 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Placebo for MK-8521
T2DM participants received once daily subcutaneous placebo for MK-8521 for 14 days.
|
Part 2: Placebo for MK-8521-T2DM
T2DM participants received once daily subcutaneous placebo for MK-8521 for 29 days.
|
Part 2: MK-8521 64 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 64 µg/day on Days 1 to 7 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
Part 2: MK-8521 120 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 120 µg/day hon Days 8 to 14 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Time-weighted Average From 0 to 24 Hours (TWA0-24hr) of Heart Rate (HR) After 14 Days of Treatment in Type 2 Diabetes Mellitus (T2DM) Participants in Part 2
|
5.05 Beats per minute
Interval 2.79 to 7.3
|
5.93 Beats per minute
Interval 3.27 to 8.6
|
-0.20 Beats per minute
Interval -4.32 to 3.93
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (predose Day 1) and up to 24 hours post Day 19 dosePopulation: The analysis population included a subset of participants who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment according to the underlying scientific model and had data available for the analysis of the endpoint. Per-protocol, non-diabetic overweight/obese participants were not planned for the TWA0-24hr analysis of heart rate.
Semi-recumbent HR was measured in triplicate with at least a 1-2-minute interval between measurements at the following time points: baseline on Day 1; Day 19: predose, 2, 4, 6, 8, 12, 16, hours post dose; and prior to dosing on Day 20. The repeated measurements were averaged before conducting the analysis. TWA0-24hr was calculated as the AUC divided by the time period of over which the measurements were made (i.e. 24 hrs.). Change from baseline TWA0-24hr HR was calculated as the TWA0-24hr HR at Day 19 minus baseline where baseline was defined as predose on Day 1.
Outcome measures
| Measure |
Part 1: MK-8521 64 μg/Day
n=18 Participants
Type 2 Diabetes Mellitus (T2DM) participants received once daily subcutaneous MK-8521 64 μg/day on Days 1 to 7 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 120 μg/Day
n=13 Participants
T2DM participants received once daily subcutaneous MK-8521 120 μg/day on Days 8 to 14 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 34 μg/Day
n=5 Participants
T2DM participants received once daily subcutaneous MK-8521 34 μg/day on Days 1 to 7 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: MK-8521 72 μg/Day
T2DM participants received once daily subcutaneous MK-8521 72 μg/day on Days 8 to 14 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: Liraglutide 0.6 mg/Day
T2DM participants received once daily subcutaneous liraglutide 0.6 mg on Day 1 and 2 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.2 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.2 mg on Days 3 to 7 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.8 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.8 mg on Days 8 to 14 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Placebo for MK-8521
T2DM participants received once daily subcutaneous placebo for MK-8521 for 14 days.
|
Part 2: Placebo for MK-8521-T2DM
T2DM participants received once daily subcutaneous placebo for MK-8521 for 29 days.
|
Part 2: MK-8521 64 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 64 µg/day on Days 1 to 7 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
Part 2: MK-8521 120 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 120 µg/day hon Days 8 to 14 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Time-weighted Average From 0 to 24 Hours (TWA0-24hr) of Heart Rate (HR) After 19 Days of Treatment in Type 2 Diabetes Mellitus (T2DM) Participants in Part 2
|
5.62 Beats per minute
Interval 3.19 to 8.05
|
6.20 Beats per minute
Interval 3.32 to 9.07
|
-2.14 Beats per minute
Interval -6.66 to 2.37
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (predose Day 1) and up to 24 hours post Day 24 dosePopulation: The analysis population included a subset of participants who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment according to the underlying scientific model and had data available for the analysis of the endpoint. Per-protocol, non-diabetic overweight/obese participants were not planned for the TWA0-24hr analysis of heart rate.
Semi-recumbent HR was measured in triplicate with at least a 1-2-minute interval between measurements at the following time points: baseline on Day 1; Day 24: predose, 2, 4, 6, 8, 12, 16, hours postdose; and prior to dosing on Day 25. The repeated measurements were averaged before conducting the analysis. TWA0-24hr was calculated as the AUC divided by the time period of over which the measurements were made (i.e. 24 hrs.). Change from baseline TWA0-24hr HR was calculated as the TWA0-24hr HR at Day 24 minus baseline where baseline was defined as predose on Day 1.
Outcome measures
| Measure |
Part 1: MK-8521 64 μg/Day
n=17 Participants
Type 2 Diabetes Mellitus (T2DM) participants received once daily subcutaneous MK-8521 64 μg/day on Days 1 to 7 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 120 μg/Day
n=11 Participants
T2DM participants received once daily subcutaneous MK-8521 120 μg/day on Days 8 to 14 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 34 μg/Day
n=5 Participants
T2DM participants received once daily subcutaneous MK-8521 34 μg/day on Days 1 to 7 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: MK-8521 72 μg/Day
T2DM participants received once daily subcutaneous MK-8521 72 μg/day on Days 8 to 14 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: Liraglutide 0.6 mg/Day
T2DM participants received once daily subcutaneous liraglutide 0.6 mg on Day 1 and 2 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.2 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.2 mg on Days 3 to 7 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.8 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.8 mg on Days 8 to 14 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Placebo for MK-8521
T2DM participants received once daily subcutaneous placebo for MK-8521 for 14 days.
|
Part 2: Placebo for MK-8521-T2DM
T2DM participants received once daily subcutaneous placebo for MK-8521 for 29 days.
|
Part 2: MK-8521 64 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 64 µg/day on Days 1 to 7 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
Part 2: MK-8521 120 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 120 µg/day hon Days 8 to 14 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Time-weighted Average From 0 to 24 Hours (TWA0-24hr) of Heart Rate (HR) After 24 Days of Treatment in Type 2 Diabetes Mellitus (T2DM) Participants in Part 2
|
7.30 Beats per minute
Interval 4.43 to 10.17
|
5.95 Beats per minute
Interval 2.5 to 9.41
|
-0.99 Beats per minute
Interval -6.28 to 4.29
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (predose Day 1) and up to 24 hours post Day 29 dosePopulation: The analysis population included a subset of participants who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment according to the underlying scientific model and had data available for the analysis of the endpoint. Per-protocol, non-diabetic overweight/obese participants were not planned for the TWA0-24hr analysis of heart rate.
Semi-recumbent HR was measured in triplicate with at least a 1-2-minute interval between measurements at the following time points: baseline on Day 1; and Day 29: predose, 2, 4, 6, 8, 12, 16 and 24 hours postdose. The repeated measurements were averaged before conducting the analysis. TWA0-24hr was calculated as the AUC divided by the time period of over which the measurements were made (i.e. 24 hrs.). Change from baseline TWA0-24hr HR was calculated as the TWA0-24hr HR at Day 29 minus baseline where baseline was defined as predose on Day 1.
Outcome measures
| Measure |
Part 1: MK-8521 64 μg/Day
n=16 Participants
Type 2 Diabetes Mellitus (T2DM) participants received once daily subcutaneous MK-8521 64 μg/day on Days 1 to 7 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 120 μg/Day
n=11 Participants
T2DM participants received once daily subcutaneous MK-8521 120 μg/day on Days 8 to 14 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 34 μg/Day
n=5 Participants
T2DM participants received once daily subcutaneous MK-8521 34 μg/day on Days 1 to 7 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: MK-8521 72 μg/Day
T2DM participants received once daily subcutaneous MK-8521 72 μg/day on Days 8 to 14 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: Liraglutide 0.6 mg/Day
T2DM participants received once daily subcutaneous liraglutide 0.6 mg on Day 1 and 2 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.2 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.2 mg on Days 3 to 7 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.8 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.8 mg on Days 8 to 14 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Placebo for MK-8521
T2DM participants received once daily subcutaneous placebo for MK-8521 for 14 days.
|
Part 2: Placebo for MK-8521-T2DM
T2DM participants received once daily subcutaneous placebo for MK-8521 for 29 days.
|
Part 2: MK-8521 64 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 64 µg/day on Days 1 to 7 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
Part 2: MK-8521 120 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 120 µg/day hon Days 8 to 14 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Time-weighted Average From 0 to 24 Hours (TWA0-24hr) of Heart Rate (HR) After 29 Days of Treatment in Type 2 Diabetes Mellitus (T2DM) Participants in Part 2
|
8.30 Beats per minute
Interval 5.31 to 11.29
|
5.84 Beats per minute
Interval 2.26 to 9.43
|
-1.31 Beats per minute
Interval -6.81 to 4.19
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (predose Day 1) and up to 24 hours post Day 7 dosePopulation: The analysis population included a subset of participants who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment according to the underlying scientific model and had data available for the analysis of the endpoint. Per-protocol, non-diabetic overweight/obese participants were not planned for the analysis of peak heart rate.
PHR was defined as the maximum time matched baseline adjusted heart rate over 24 hours. Semi-recumbent PHR was measured in triplicate with at least a 1-2-minute interval between measurements at the following time points: baseline on Day 1; Day 7: predose, 2, 4, 6, 8, 12, and 16 hours postdose; and prior to dosing on Day 8. The repeated measurements were averaged before conducting the analysis. Change from baseline PHR was calculated as the peak heart rate at Day 7 minus baseline where baseline was defined as predose on Day 1.
Outcome measures
| Measure |
Part 1: MK-8521 64 μg/Day
n=18 Participants
Type 2 Diabetes Mellitus (T2DM) participants received once daily subcutaneous MK-8521 64 μg/day on Days 1 to 7 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 120 μg/Day
n=13 Participants
T2DM participants received once daily subcutaneous MK-8521 120 μg/day on Days 8 to 14 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 34 μg/Day
n=6 Participants
T2DM participants received once daily subcutaneous MK-8521 34 μg/day on Days 1 to 7 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: MK-8521 72 μg/Day
T2DM participants received once daily subcutaneous MK-8521 72 μg/day on Days 8 to 14 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: Liraglutide 0.6 mg/Day
T2DM participants received once daily subcutaneous liraglutide 0.6 mg on Day 1 and 2 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.2 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.2 mg on Days 3 to 7 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.8 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.8 mg on Days 8 to 14 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Placebo for MK-8521
T2DM participants received once daily subcutaneous placebo for MK-8521 for 14 days.
|
Part 2: Placebo for MK-8521-T2DM
T2DM participants received once daily subcutaneous placebo for MK-8521 for 29 days.
|
Part 2: MK-8521 64 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 64 µg/day on Days 1 to 7 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
Part 2: MK-8521 120 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 120 µg/day hon Days 8 to 14 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Peak Heart Rate (PHR) at Day 7 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 2
|
7.94 Beats per minute
Interval 5.76 to 10.13
|
11.91 Beats per minute
Interval 9.3 to 14.53
|
8.65 Beats per minute
Interval 4.86 to 12.43
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (predose Day 1) and up to 24 hours post Day 14 dosePopulation: The analysis population included a subset of participants who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment according to the underlying scientific model and had data available for the analysis of the endpoint. Per-protocol, non-diabetic overweight/obese participants were not planned for the analysis of peak heart rate.
PHR was defined as the maximum time matched baseline adjusted heart rate over 24 hours. Semi-recumbent PHR was measured in triplicate with at least a 1-2-minute interval between measurements at the following time points: baseline on Day 1; Day 14: predose, 2, 4, 6, 8, 12, and 16 hours postdose; and prior to dosing on Day 15. The repeated measurements were averaged before conducting the analysis. Change from baseline PHR was calculated as the peak heart rate at Day 14 minus baseline where baseline was defined as predose on Day 1.
Outcome measures
| Measure |
Part 1: MK-8521 64 μg/Day
n=18 Participants
Type 2 Diabetes Mellitus (T2DM) participants received once daily subcutaneous MK-8521 64 μg/day on Days 1 to 7 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 120 μg/Day
n=13 Participants
T2DM participants received once daily subcutaneous MK-8521 120 μg/day on Days 8 to 14 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 34 μg/Day
n=6 Participants
T2DM participants received once daily subcutaneous MK-8521 34 μg/day on Days 1 to 7 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: MK-8521 72 μg/Day
T2DM participants received once daily subcutaneous MK-8521 72 μg/day on Days 8 to 14 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: Liraglutide 0.6 mg/Day
T2DM participants received once daily subcutaneous liraglutide 0.6 mg on Day 1 and 2 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.2 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.2 mg on Days 3 to 7 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.8 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.8 mg on Days 8 to 14 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Placebo for MK-8521
T2DM participants received once daily subcutaneous placebo for MK-8521 for 14 days.
|
Part 2: Placebo for MK-8521-T2DM
T2DM participants received once daily subcutaneous placebo for MK-8521 for 29 days.
|
Part 2: MK-8521 64 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 64 µg/day on Days 1 to 7 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
Part 2: MK-8521 120 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 120 µg/day hon Days 8 to 14 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Peak Heart Rate (PHR) at Day 14 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 2
|
11.41 Beats per minute
Interval 8.5 to 14.32
|
13.00 Beats per minute
Interval 9.58 to 16.41
|
8.90 Beats per minute
Interval 3.87 to 13.93
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (predose Day 1) and up to 24 hours post Day 19 dosePopulation: The analysis population included a subset of participants who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment according to the underlying scientific model and had data available for the analysis of the endpoint. Per-protocol, non-diabetic overweight/obese participants were not planned for the analysis of peak heart rate.
PHR was defined as the maximum time matched baseline adjusted heart rate over 24 hours. Semi-recumbent PHR was measured in triplicate with at least a 1-2-minute interval between measurements at the following time points: baseline on Day 1; Day 19: predose, 2, 4, 6, 8, 12, and 16 hours postdose; and prior to dosing on Day 20. The repeated measurements were averaged before conducting the analysis. Change from baseline PHR was calculated as the peak heart rate at Day 19 minus baseline where baseline was defined as predose on Day 1.
Outcome measures
| Measure |
Part 1: MK-8521 64 μg/Day
n=18 Participants
Type 2 Diabetes Mellitus (T2DM) participants received once daily subcutaneous MK-8521 64 μg/day on Days 1 to 7 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 120 μg/Day
n=13 Participants
T2DM participants received once daily subcutaneous MK-8521 120 μg/day on Days 8 to 14 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 34 μg/Day
n=5 Participants
T2DM participants received once daily subcutaneous MK-8521 34 μg/day on Days 1 to 7 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: MK-8521 72 μg/Day
T2DM participants received once daily subcutaneous MK-8521 72 μg/day on Days 8 to 14 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: Liraglutide 0.6 mg/Day
T2DM participants received once daily subcutaneous liraglutide 0.6 mg on Day 1 and 2 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.2 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.2 mg on Days 3 to 7 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.8 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.8 mg on Days 8 to 14 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Placebo for MK-8521
T2DM participants received once daily subcutaneous placebo for MK-8521 for 14 days.
|
Part 2: Placebo for MK-8521-T2DM
T2DM participants received once daily subcutaneous placebo for MK-8521 for 29 days.
|
Part 2: MK-8521 64 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 64 µg/day on Days 1 to 7 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
Part 2: MK-8521 120 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 120 µg/day hon Days 8 to 14 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Peak Heart Rate (PHR) at Day 19 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 2
|
11.26 Beats per minute
Interval 8.28 to 14.24
|
14.75 Beats per minute
Interval 11.25 to 18.25
|
7.30 Beats per minute
Interval 2.0 to 12.61
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (predose Day 1) and up to 24 hours post Day 24 dosePopulation: The analysis population included a subset of participants who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment according to the underlying scientific model and had data available for the analysis of the endpoint. Per-protocol, non-diabetic overweight/obese participants were not planned for the analysis of peak heart rate.
PHR was defined as the maximum time matched baseline adjusted heart rate over 24 hours. Semi-recumbent PHR was measured in triplicate with at least a 1-2-minute interval between measurements at the following time points: baseline on Day 1; Day 24: predose, 2, 4, 6, 8, 12, and 16 hours postdose; and prior to dosing on Day 25. The repeated measurements were averaged before conducting the analysis. Change from baseline PHR was calculated as the peak heart rate at Day 24 minus baseline where baseline was defined as predose on Day 1.
Outcome measures
| Measure |
Part 1: MK-8521 64 μg/Day
n=17 Participants
Type 2 Diabetes Mellitus (T2DM) participants received once daily subcutaneous MK-8521 64 μg/day on Days 1 to 7 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 120 μg/Day
n=11 Participants
T2DM participants received once daily subcutaneous MK-8521 120 μg/day on Days 8 to 14 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 34 μg/Day
n=5 Participants
T2DM participants received once daily subcutaneous MK-8521 34 μg/day on Days 1 to 7 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: MK-8521 72 μg/Day
T2DM participants received once daily subcutaneous MK-8521 72 μg/day on Days 8 to 14 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: Liraglutide 0.6 mg/Day
T2DM participants received once daily subcutaneous liraglutide 0.6 mg on Day 1 and 2 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.2 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.2 mg on Days 3 to 7 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.8 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.8 mg on Days 8 to 14 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Placebo for MK-8521
T2DM participants received once daily subcutaneous placebo for MK-8521 for 14 days.
|
Part 2: Placebo for MK-8521-T2DM
T2DM participants received once daily subcutaneous placebo for MK-8521 for 29 days.
|
Part 2: MK-8521 64 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 64 µg/day on Days 1 to 7 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
Part 2: MK-8521 120 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 120 µg/day hon Days 8 to 14 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Peak Heart Rate (PHR) at Day 24 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 2
|
14.09 Beats per minute
Interval 10.6 to 17.57
|
14.06 Beats per minute
Interval 9.85 to 18.27
|
9.39 Beats per minute
Interval 3.03 to 15.76
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (predose Day 1) and up to 24 hours post Day 29 dosePopulation: The analysis population included a subset of participants who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment according to the underlying scientific model and had data available for the analysis of the endpoint. Per-protocol, non-diabetic overweight/obese participants were not planned for the analysis of peak heart rate.
PHR was defined as the maximum time matched baseline adjusted heart rate over 24 hours. Semi-recumbent PHR was measured in triplicate with at least a 1-2-minute interval between measurements at the following time points: baseline on Day 1; and Day 29: predose 2, 4, 6, 8, 12, 16, and 24 hours post dose. The repeated measurements were averaged before conducting the analysis. Change from baseline PHR was calculated as the peak heart rate at Day 29 minus baseline where baseline was defined as predose on Day 1.
Outcome measures
| Measure |
Part 1: MK-8521 64 μg/Day
n=16 Participants
Type 2 Diabetes Mellitus (T2DM) participants received once daily subcutaneous MK-8521 64 μg/day on Days 1 to 7 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 120 μg/Day
n=11 Participants
T2DM participants received once daily subcutaneous MK-8521 120 μg/day on Days 8 to 14 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 34 μg/Day
n=5 Participants
T2DM participants received once daily subcutaneous MK-8521 34 μg/day on Days 1 to 7 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: MK-8521 72 μg/Day
T2DM participants received once daily subcutaneous MK-8521 72 μg/day on Days 8 to 14 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: Liraglutide 0.6 mg/Day
T2DM participants received once daily subcutaneous liraglutide 0.6 mg on Day 1 and 2 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.2 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.2 mg on Days 3 to 7 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.8 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.8 mg on Days 8 to 14 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Placebo for MK-8521
T2DM participants received once daily subcutaneous placebo for MK-8521 for 14 days.
|
Part 2: Placebo for MK-8521-T2DM
T2DM participants received once daily subcutaneous placebo for MK-8521 for 29 days.
|
Part 2: MK-8521 64 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 64 µg/day on Days 1 to 7 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
Part 2: MK-8521 120 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 120 µg/day hon Days 8 to 14 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Peak Heart Rate (PHR) at Day 29 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 2
|
16.01 Beats per minute
Interval 12.88 to 19.13
|
12.66 Beats per minute
Interval 8.91 to 16.41
|
7.13 Beats per minute
Interval 1.49 to 12.76
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (predose Day 1) and Day 8 (24 hours after Day 7)Population: The analysis population included a subset of participants who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment according to the underlying scientific model and had data available for the analysis of the endpoint. Per-protocol, non-diabetic overweight/obese participants were not planned for the analysis of resting morning heart rate.
Semi-recumbent RMHR was measured in triplicate with at least a 1-2-minute interval between measurements. The repeated measurements were averaged for each time point. Change from baseline RMHR was calculated as the RMHR 24 hours after the Day 7 dose (predose Day 8) minus baseline. Baseline was an average of 2 readings prior to dosing on Day 1.
Outcome measures
| Measure |
Part 1: MK-8521 64 μg/Day
n=18 Participants
Type 2 Diabetes Mellitus (T2DM) participants received once daily subcutaneous MK-8521 64 μg/day on Days 1 to 7 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 120 μg/Day
n=13 Participants
T2DM participants received once daily subcutaneous MK-8521 120 μg/day on Days 8 to 14 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 34 μg/Day
n=6 Participants
T2DM participants received once daily subcutaneous MK-8521 34 μg/day on Days 1 to 7 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: MK-8521 72 μg/Day
T2DM participants received once daily subcutaneous MK-8521 72 μg/day on Days 8 to 14 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: Liraglutide 0.6 mg/Day
T2DM participants received once daily subcutaneous liraglutide 0.6 mg on Day 1 and 2 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.2 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.2 mg on Days 3 to 7 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.8 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.8 mg on Days 8 to 14 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Placebo for MK-8521
T2DM participants received once daily subcutaneous placebo for MK-8521 for 14 days.
|
Part 2: Placebo for MK-8521-T2DM
T2DM participants received once daily subcutaneous placebo for MK-8521 for 29 days.
|
Part 2: MK-8521 64 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 64 µg/day on Days 1 to 7 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
Part 2: MK-8521 120 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 120 µg/day hon Days 8 to 14 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Resting Morning Heart Rate (RMHR) After the Day 7 Dose for Type 2 Diabetes Mellitus (T2DM) Participants in Part 2
|
1.65 Beats per minute
Interval -1.0 to 4.29
|
5.20 Beats per minute
Interval 2.07 to 8.33
|
0.59 Beats per minute
Interval -3.99 to 5.18
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (predose Day 1) and Day 15 (24 hours after Day 14)Population: The analysis population included a subset of participants who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment according to the underlying scientific model and had data available for the analysis of the endpoint. Per-protocol, non-diabetic overweight/obese participants were not planned for the analysis of resting morning heart rate.
Semi-recumbent RMHR was measured in triplicate with at least a 1-2-minute interval between measurements. The repeated measurements were averaged for each time point. Change from baseline RMHR was calculated as the RMHR 24 hours after the Day 14 dose (predose Day 15) minus baseline. Baseline was an average of 2 readings prior to dosing on Day 1.
Outcome measures
| Measure |
Part 1: MK-8521 64 μg/Day
n=18 Participants
Type 2 Diabetes Mellitus (T2DM) participants received once daily subcutaneous MK-8521 64 μg/day on Days 1 to 7 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 120 μg/Day
n=13 Participants
T2DM participants received once daily subcutaneous MK-8521 120 μg/day on Days 8 to 14 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 34 μg/Day
n=5 Participants
T2DM participants received once daily subcutaneous MK-8521 34 μg/day on Days 1 to 7 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: MK-8521 72 μg/Day
T2DM participants received once daily subcutaneous MK-8521 72 μg/day on Days 8 to 14 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: Liraglutide 0.6 mg/Day
T2DM participants received once daily subcutaneous liraglutide 0.6 mg on Day 1 and 2 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.2 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.2 mg on Days 3 to 7 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.8 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.8 mg on Days 8 to 14 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Placebo for MK-8521
T2DM participants received once daily subcutaneous placebo for MK-8521 for 14 days.
|
Part 2: Placebo for MK-8521-T2DM
T2DM participants received once daily subcutaneous placebo for MK-8521 for 29 days.
|
Part 2: MK-8521 64 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 64 µg/day on Days 1 to 7 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
Part 2: MK-8521 120 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 120 µg/day hon Days 8 to 14 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Resting Morning Heart Rate (RMHR) After the Day 14 Dose for Type 2 Diabetes Mellitus (T2DM) Participants in Part 2
|
4.22 Beats per minute
Interval 1.58 to 6.87
|
5.38 Beats per minute
Interval 2.25 to 8.51
|
-4.42 Beats per minute
Interval -9.32 to 0.47
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (predose Day 1) and Day 20 (24 hours after Day 19)Population: The analysis population included a subset of participants who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment according to the underlying scientific model and had data available for the analysis of the endpoint. Per-protocol, non-diabetic overweight/obese participants were not planned for the analysis of resting morning heart rate.
Semi-recumbent RMHR was measured in triplicate with at least a 1-2-minute interval between measurements. The repeated measurements were averaged for each time point. Change from baseline RMHR was calculated as the RMHR 24 hours after the Day 19 dose (predose Day 20) minus baseline. Baseline was an average of 2 readings prior to dosing on Day 1.
Outcome measures
| Measure |
Part 1: MK-8521 64 μg/Day
n=18 Participants
Type 2 Diabetes Mellitus (T2DM) participants received once daily subcutaneous MK-8521 64 μg/day on Days 1 to 7 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 120 μg/Day
n=12 Participants
T2DM participants received once daily subcutaneous MK-8521 120 μg/day on Days 8 to 14 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 34 μg/Day
n=5 Participants
T2DM participants received once daily subcutaneous MK-8521 34 μg/day on Days 1 to 7 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: MK-8521 72 μg/Day
T2DM participants received once daily subcutaneous MK-8521 72 μg/day on Days 8 to 14 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: Liraglutide 0.6 mg/Day
T2DM participants received once daily subcutaneous liraglutide 0.6 mg on Day 1 and 2 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.2 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.2 mg on Days 3 to 7 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.8 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.8 mg on Days 8 to 14 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Placebo for MK-8521
T2DM participants received once daily subcutaneous placebo for MK-8521 for 14 days.
|
Part 2: Placebo for MK-8521-T2DM
T2DM participants received once daily subcutaneous placebo for MK-8521 for 29 days.
|
Part 2: MK-8521 64 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 64 µg/day on Days 1 to 7 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
Part 2: MK-8521 120 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 120 µg/day hon Days 8 to 14 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Resting Morning Heart Rate (RMHR) After the Day 19 Dose for Type 2 Diabetes Mellitus (T2DM) Participants in Part 2
|
6.41 Beats per minute
Interval 3.76 to 9.05
|
10.44 Beats per minute
Interval 7.24 to 13.65
|
-3.82 Beats per minute
Interval -8.72 to 1.07
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (predose Day 1) and Day 25 (24 hours after Day 24)Population: The analysis population included a subset of participants who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment according to the underlying scientific model and had data available for the analysis of the endpoint. Per-protocol, non-diabetic overweight/obese participants were not planned for the analysis of resting morning heart rate.
Semi-recumbent RMHR was measured in triplicate with at least a 1-2-minute interval between measurements. The repeated measurements were averaged for each time point. Change from baseline RMHR was calculated as the RMHR 24 hours after the Day 24 dose (predose Day 25) minus baseline. Baseline was an average of 2 readings prior to dosing on Day 1.
Outcome measures
| Measure |
Part 1: MK-8521 64 μg/Day
n=16 Participants
Type 2 Diabetes Mellitus (T2DM) participants received once daily subcutaneous MK-8521 64 μg/day on Days 1 to 7 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 120 μg/Day
n=11 Participants
T2DM participants received once daily subcutaneous MK-8521 120 μg/day on Days 8 to 14 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 34 μg/Day
n=5 Participants
T2DM participants received once daily subcutaneous MK-8521 34 μg/day on Days 1 to 7 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: MK-8521 72 μg/Day
T2DM participants received once daily subcutaneous MK-8521 72 μg/day on Days 8 to 14 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: Liraglutide 0.6 mg/Day
T2DM participants received once daily subcutaneous liraglutide 0.6 mg on Day 1 and 2 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.2 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.2 mg on Days 3 to 7 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.8 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.8 mg on Days 8 to 14 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Placebo for MK-8521
T2DM participants received once daily subcutaneous placebo for MK-8521 for 14 days.
|
Part 2: Placebo for MK-8521-T2DM
T2DM participants received once daily subcutaneous placebo for MK-8521 for 29 days.
|
Part 2: MK-8521 64 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 64 µg/day on Days 1 to 7 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
Part 2: MK-8521 120 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 120 µg/day hon Days 8 to 14 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Resting Morning Heart Rate (RMHR) After the Day 24 Dose for Type 2 Diabetes Mellitus (T2DM) Participants in Part 2
|
7.51 Beats per minute
Interval 4.77 to 10.25
|
9.63 Beats per minute
Interval 6.35 to 12.91
|
-5.82 Beats per minute
Interval -10.72 to -0.93
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (predose Day 1) and Day 30 (24 hours after Day 29)Population: The analysis population included a subset of participants who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment according to the underlying scientific model and had data available for the analysis of the endpoint. Per-protocol, non-diabetic overweight/obese participants were not planned for the analysis of resting morning heart rate.
Semi-recumbent RMHR was measured in triplicate with at least a 1-2-minute interval between measurements. The repeated measurements were averaged for each time point. Change from baseline RMHR was calculated as the RMHR 24 hours after the Day 29 dose minus baseline. Baseline was an average of 2 readings prior to dosing on Day 1.
Outcome measures
| Measure |
Part 1: MK-8521 64 μg/Day
n=16 Participants
Type 2 Diabetes Mellitus (T2DM) participants received once daily subcutaneous MK-8521 64 μg/day on Days 1 to 7 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 120 μg/Day
n=11 Participants
T2DM participants received once daily subcutaneous MK-8521 120 μg/day on Days 8 to 14 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 34 μg/Day
n=5 Participants
T2DM participants received once daily subcutaneous MK-8521 34 μg/day on Days 1 to 7 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: MK-8521 72 μg/Day
T2DM participants received once daily subcutaneous MK-8521 72 μg/day on Days 8 to 14 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: Liraglutide 0.6 mg/Day
T2DM participants received once daily subcutaneous liraglutide 0.6 mg on Day 1 and 2 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.2 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.2 mg on Days 3 to 7 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.8 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.8 mg on Days 8 to 14 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Placebo for MK-8521
T2DM participants received once daily subcutaneous placebo for MK-8521 for 14 days.
|
Part 2: Placebo for MK-8521-T2DM
T2DM participants received once daily subcutaneous placebo for MK-8521 for 29 days.
|
Part 2: MK-8521 64 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 64 µg/day on Days 1 to 7 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
Part 2: MK-8521 120 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 120 µg/day hon Days 8 to 14 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Resting Morning Heart Rate (RMHR) After the Day 29 Dose for Type 2 Diabetes Mellitus (T2DM) Participants in Part 2
|
9.41 Beats per minute
Interval 6.67 to 12.15
|
7.30 Beats per minute
Interval 4.01 to 10.58
|
-1.02 Beats per minute
Interval -5.92 to 3.87
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose and 1, 2, 4, 6, 8, 10, 12, 16, and 24 hours post-dose on Days 1, 7, and 14Population: The analysis population included a subset of participants who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment according to the underlying scientific model and had data available for the analysis of the endpoint.
AUC0-24hr was the area under the concentration-time curve of MK-8521 from time zero to 24 hours after administration. Plasma samples were collected from predose to 24 hours postdose for determination of AUC0-24hr. Individual values were natural log-transformed and evaluated with a linear-mixed effects model containing fixed effects for treatment, day, and treatment by day interaction, and a random effect for participant. Kenward and Roger's method was used to calculate the degree of freedom for the fixed effects. AUC0-24hr is presented as geometric mean and percent coefficient of variation of geometric mean.
Outcome measures
| Measure |
Part 1: MK-8521 64 μg/Day
n=9 Participants
Type 2 Diabetes Mellitus (T2DM) participants received once daily subcutaneous MK-8521 64 μg/day on Days 1 to 7 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 120 μg/Day
n=8 Participants
T2DM participants received once daily subcutaneous MK-8521 120 μg/day on Days 8 to 14 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 34 μg/Day
T2DM participants received once daily subcutaneous MK-8521 34 μg/day on Days 1 to 7 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: MK-8521 72 μg/Day
T2DM participants received once daily subcutaneous MK-8521 72 μg/day on Days 8 to 14 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: Liraglutide 0.6 mg/Day
T2DM participants received once daily subcutaneous liraglutide 0.6 mg on Day 1 and 2 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.2 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.2 mg on Days 3 to 7 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.8 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.8 mg on Days 8 to 14 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Placebo for MK-8521
T2DM participants received once daily subcutaneous placebo for MK-8521 for 14 days.
|
Part 2: Placebo for MK-8521-T2DM
T2DM participants received once daily subcutaneous placebo for MK-8521 for 29 days.
|
Part 2: MK-8521 64 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 64 µg/day on Days 1 to 7 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
Part 2: MK-8521 120 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 120 µg/day hon Days 8 to 14 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve From 0 to 24 Hours (AUC0-24hr) of MK-8521 on Days 1, 7, and 14 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 1
Day 1
|
6.11 nM•hour
Geometric Coefficient of Variation 47.6
|
2.25 nM•hour
Geometric Coefficient of Variation 27.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Concentration-time Curve From 0 to 24 Hours (AUC0-24hr) of MK-8521 on Days 1, 7, and 14 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 1
Day 7
|
14.4 nM•hour
Geometric Coefficient of Variation 55.9
|
5.63 nM•hour
Geometric Coefficient of Variation 24.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Concentration-time Curve From 0 to 24 Hours (AUC0-24hr) of MK-8521 on Days 1, 7, and 14 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 1
Day 14
|
32.8 nM•hour
Geometric Coefficient of Variation 42.8
|
12.6 nM•hour
Geometric Coefficient of Variation 26.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose and 1, 2, 4, 6, 8, 10, 12, 16, and 24 hours post-dose on Days 1 and 7Population: The analysis population included a subset of participants who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment according to the underlying scientific model and had data available for the analysis of the endpoint.
Cmax was the maximum observed concentration of MK-8521 in plasma after administration. Plasma samples were collected from predose to 24 hours postdose for determination of Cmax. Individual values were natural log-transformed and evaluated with a linear-mixed effects model containing fixed effects for treatment, day, and treatment by day interaction, and a random effect for participant. Kenward and Roger's method was used to calculate the degree of freedom for the fixed effects. Cmax is presented as geometric mean and percent coefficient of variation of geometric mean.
Outcome measures
| Measure |
Part 1: MK-8521 64 μg/Day
n=9 Participants
Type 2 Diabetes Mellitus (T2DM) participants received once daily subcutaneous MK-8521 64 μg/day on Days 1 to 7 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 120 μg/Day
n=8 Participants
T2DM participants received once daily subcutaneous MK-8521 120 μg/day on Days 8 to 14 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 34 μg/Day
T2DM participants received once daily subcutaneous MK-8521 34 μg/day on Days 1 to 7 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: MK-8521 72 μg/Day
T2DM participants received once daily subcutaneous MK-8521 72 μg/day on Days 8 to 14 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: Liraglutide 0.6 mg/Day
T2DM participants received once daily subcutaneous liraglutide 0.6 mg on Day 1 and 2 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.2 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.2 mg on Days 3 to 7 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.8 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.8 mg on Days 8 to 14 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Placebo for MK-8521
T2DM participants received once daily subcutaneous placebo for MK-8521 for 14 days.
|
Part 2: Placebo for MK-8521-T2DM
T2DM participants received once daily subcutaneous placebo for MK-8521 for 29 days.
|
Part 2: MK-8521 64 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 64 µg/day on Days 1 to 7 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
Part 2: MK-8521 120 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 120 µg/day hon Days 8 to 14 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Concentration (Cmax) of MK-8521 on Days 1 and 7 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 1
Day 1
|
0.350 nM
Geometric Coefficient of Variation 41.4
|
0.128 nM
Geometric Coefficient of Variation 21.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Concentration (Cmax) of MK-8521 on Days 1 and 7 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 1
Day 7
|
0.710 nM
Geometric Coefficient of Variation 57.6
|
0.275 nM
Geometric Coefficient of Variation 31.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose and 1, 2, 4, 6, 8, 10, 12, 16, 24, 72, 96, and 120 hours post-dose on Day 14Population: The analysis population included a subset of participants who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment according to the underlying scientific model and had data available for the analysis of the endpoint.
Cmax was the maximum observed concentration of MK-8521 in plasma after administration on Day 14. Plasma samples were collected from predose to 120 hours postdose for determination of Cmax. Individual values were natural log-transformed and evaluated with a linear-mixed effects model containing fixed effects for treatment, day, and treatment by day interaction, and a random effect for participant. Kenward and Roger's method was used to calculate the degree of freedom for the fixed effects. Cmax is presented as geometric mean and percent coefficient of variation of geometric mean.
Outcome measures
| Measure |
Part 1: MK-8521 64 μg/Day
n=7 Participants
Type 2 Diabetes Mellitus (T2DM) participants received once daily subcutaneous MK-8521 64 μg/day on Days 1 to 7 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 120 μg/Day
n=8 Participants
T2DM participants received once daily subcutaneous MK-8521 120 μg/day on Days 8 to 14 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 34 μg/Day
T2DM participants received once daily subcutaneous MK-8521 34 μg/day on Days 1 to 7 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: MK-8521 72 μg/Day
T2DM participants received once daily subcutaneous MK-8521 72 μg/day on Days 8 to 14 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: Liraglutide 0.6 mg/Day
T2DM participants received once daily subcutaneous liraglutide 0.6 mg on Day 1 and 2 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.2 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.2 mg on Days 3 to 7 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.8 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.8 mg on Days 8 to 14 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Placebo for MK-8521
T2DM participants received once daily subcutaneous placebo for MK-8521 for 14 days.
|
Part 2: Placebo for MK-8521-T2DM
T2DM participants received once daily subcutaneous placebo for MK-8521 for 29 days.
|
Part 2: MK-8521 64 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 64 µg/day on Days 1 to 7 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
Part 2: MK-8521 120 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 120 µg/day hon Days 8 to 14 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Concentration (Cmax) of MK-8521 on Day 14 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 1
|
1.70 nM
Geometric Coefficient of Variation 38.4
|
0.619 nM
Geometric Coefficient of Variation 27.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose on Days 2, 7, and 14Population: The analysis population included a subset of participants who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment according to the underlying scientific model and had data available for the analysis of the endpoint.
Ctrough was the lowest observed concentration of MK-8521 in plasma. Plasma samples were collected predose on Day 2 (sampled after the Day 1 dose and prior to Day 2 dose), 7, and 14 for determination of Ctrough. Individual values were natural log-transformed and evaluated with a linear-mixed effects model containing fixed effects for treatment, day, and treatment by day interaction, and a random effect for participant. Kenward and Roger's method was used to calculate the degree of freedom for the fixed effects. Ctrough is presented as geometric mean and percent coefficient of variation of geometric mean.
Outcome measures
| Measure |
Part 1: MK-8521 64 μg/Day
n=9 Participants
Type 2 Diabetes Mellitus (T2DM) participants received once daily subcutaneous MK-8521 64 μg/day on Days 1 to 7 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 120 μg/Day
n=8 Participants
T2DM participants received once daily subcutaneous MK-8521 120 μg/day on Days 8 to 14 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 34 μg/Day
T2DM participants received once daily subcutaneous MK-8521 34 μg/day on Days 1 to 7 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: MK-8521 72 μg/Day
T2DM participants received once daily subcutaneous MK-8521 72 μg/day on Days 8 to 14 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: Liraglutide 0.6 mg/Day
T2DM participants received once daily subcutaneous liraglutide 0.6 mg on Day 1 and 2 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.2 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.2 mg on Days 3 to 7 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.8 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.8 mg on Days 8 to 14 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Placebo for MK-8521
T2DM participants received once daily subcutaneous placebo for MK-8521 for 14 days.
|
Part 2: Placebo for MK-8521-T2DM
T2DM participants received once daily subcutaneous placebo for MK-8521 for 29 days.
|
Part 2: MK-8521 64 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 64 µg/day on Days 1 to 7 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
Part 2: MK-8521 120 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 120 µg/day hon Days 8 to 14 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Trough Concentration (Ctrough) of MK-8521 on Days 1, 7, and 14 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 1
Day 1
|
0.322 nM
Geometric Coefficient of Variation 33.2
|
0.119 nM
Geometric Coefficient of Variation 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Trough Concentration (Ctrough) of MK-8521 on Days 1, 7, and 14 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 1
Day 14
|
1.16 nM
Geometric Coefficient of Variation 43.3
|
0.506 nM
Geometric Coefficient of Variation 27.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Trough Concentration (Ctrough) of MK-8521 on Days 1, 7, and 14 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 1
Day 7
|
0.442 nM
Geometric Coefficient of Variation 83.6
|
0.207 nM
Geometric Coefficient of Variation 21.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose and 1, 2, 4, 6, 8, 10, 12, 16, and 24 hours post-dose on Days 1 and 7Population: The analysis population included a subset of participants who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment according to the underlying scientific model and had data available for the analysis of the endpoint.
Tmax was the time required to reach the maximum concentration of MK-8521 in plasma. Plasma samples were collected from predose to 24 hours postdose for determination of Tmax. Tmax is presented as median with a full range.
Outcome measures
| Measure |
Part 1: MK-8521 64 μg/Day
n=9 Participants
Type 2 Diabetes Mellitus (T2DM) participants received once daily subcutaneous MK-8521 64 μg/day on Days 1 to 7 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 120 μg/Day
n=8 Participants
T2DM participants received once daily subcutaneous MK-8521 120 μg/day on Days 8 to 14 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 34 μg/Day
T2DM participants received once daily subcutaneous MK-8521 34 μg/day on Days 1 to 7 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: MK-8521 72 μg/Day
T2DM participants received once daily subcutaneous MK-8521 72 μg/day on Days 8 to 14 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: Liraglutide 0.6 mg/Day
T2DM participants received once daily subcutaneous liraglutide 0.6 mg on Day 1 and 2 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.2 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.2 mg on Days 3 to 7 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.8 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.8 mg on Days 8 to 14 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Placebo for MK-8521
T2DM participants received once daily subcutaneous placebo for MK-8521 for 14 days.
|
Part 2: Placebo for MK-8521-T2DM
T2DM participants received once daily subcutaneous placebo for MK-8521 for 29 days.
|
Part 2: MK-8521 64 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 64 µg/day on Days 1 to 7 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
Part 2: MK-8521 120 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 120 µg/day hon Days 8 to 14 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Maximum Concentration (Tmax) of MK-8521 on Days 1 and 7 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 1
Day 1
|
16 Hours
Interval 10.0 to 24.0
|
16 Hours
Interval 10.0 to 24.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time to Maximum Concentration (Tmax) of MK-8521 on Days 1 and 7 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 1
Day 7
|
7 Hours
Interval 6.0 to 10.0
|
6 Hours
Interval 1.0 to 10.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose and 1, 2, 4, 6, 8, 10, 12, 16, 24, 72, 96, and 120 hours post-dose on Day 14Population: The analysis population included a subset of participants who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment according to the underlying scientific model and had data available for the analysis of the endpoint.
Tmax was the time required to reach the maximum concentration of MK-8521 in plasma. Plasma samples were collected from predose to 120 hours postdose for determination of Tmax. Tmax is presented as median with a full range.
Outcome measures
| Measure |
Part 1: MK-8521 64 μg/Day
n=7 Participants
Type 2 Diabetes Mellitus (T2DM) participants received once daily subcutaneous MK-8521 64 μg/day on Days 1 to 7 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 120 μg/Day
n=8 Participants
T2DM participants received once daily subcutaneous MK-8521 120 μg/day on Days 8 to 14 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 34 μg/Day
T2DM participants received once daily subcutaneous MK-8521 34 μg/day on Days 1 to 7 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: MK-8521 72 μg/Day
T2DM participants received once daily subcutaneous MK-8521 72 μg/day on Days 8 to 14 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: Liraglutide 0.6 mg/Day
T2DM participants received once daily subcutaneous liraglutide 0.6 mg on Day 1 and 2 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.2 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.2 mg on Days 3 to 7 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.8 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.8 mg on Days 8 to 14 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Placebo for MK-8521
T2DM participants received once daily subcutaneous placebo for MK-8521 for 14 days.
|
Part 2: Placebo for MK-8521-T2DM
T2DM participants received once daily subcutaneous placebo for MK-8521 for 29 days.
|
Part 2: MK-8521 64 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 64 µg/day on Days 1 to 7 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
Part 2: MK-8521 120 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 120 µg/day hon Days 8 to 14 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Maximum Concentration (Tmax) of MK-8521 on Day 14 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 1
|
8 Hours
Interval 1.0 to 8.0
|
6 Hours
Interval 4.0 to 12.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose and 1, 2, 4, 6, 8, 10, 12, 16, and 24 hours post-dose on Days 1 and 7Population: The analysis population included a subset of participants who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment according to the underlying scientific model and had data available for the analysis of the endpoint. t1/2 was not measured for Days 1 and 7 since terminal phase was not adequately captured with sampling times up to 24 hours post dose.
t1/2 was the time required to divide the MK-8521 concentration by half after reaching pseudo-equilibrium. Plasma samples were collected from predose to 24 hours postdose for determination of t1/2. t1/2 is presented as geometric mean and percent coefficient of variation of geometric mean.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Predose and 1, 2, 4, 6, 8, 10, 12, 16, 24, 72, 96, and 120 hours post-dose on Day 14Population: The analysis population included a subset of participants who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment according to the underlying scientific model and had data available for the analysis of the endpoint.
t1/2 was the time required to divide the MK-8521 concentration by half after reaching pseudo-equilibrium. Plasma samples were collected from predose to 120 hours postdose for determination of t1/2. t1/2 was measured on Day 14 which is the longest time point for sampling for T2DM participants in Part 1. t1/2 is presented as geometric mean and percent coefficient of variation of geometric mean.
Outcome measures
| Measure |
Part 1: MK-8521 64 μg/Day
n=7 Participants
Type 2 Diabetes Mellitus (T2DM) participants received once daily subcutaneous MK-8521 64 μg/day on Days 1 to 7 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 120 μg/Day
n=8 Participants
T2DM participants received once daily subcutaneous MK-8521 120 μg/day on Days 8 to 14 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 34 μg/Day
T2DM participants received once daily subcutaneous MK-8521 34 μg/day on Days 1 to 7 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: MK-8521 72 μg/Day
T2DM participants received once daily subcutaneous MK-8521 72 μg/day on Days 8 to 14 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: Liraglutide 0.6 mg/Day
T2DM participants received once daily subcutaneous liraglutide 0.6 mg on Day 1 and 2 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.2 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.2 mg on Days 3 to 7 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.8 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.8 mg on Days 8 to 14 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Placebo for MK-8521
T2DM participants received once daily subcutaneous placebo for MK-8521 for 14 days.
|
Part 2: Placebo for MK-8521-T2DM
T2DM participants received once daily subcutaneous placebo for MK-8521 for 29 days.
|
Part 2: MK-8521 64 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 64 µg/day on Days 1 to 7 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
Part 2: MK-8521 120 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 120 µg/day hon Days 8 to 14 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Terminal Half Life (t1/2) of MK-8521 on Day 14 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 1
|
15.6 Hours
Geometric Coefficient of Variation 16.1
|
17.2 Hours
Geometric Coefficient of Variation 17.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose and 1, 2, 4, 6, 8, 10, 12, 16, and 24 hours post-dose on Days 1 and 7Population: The analysis population included a subset of participants who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment according to the underlying scientific model and had data available for the analysis of the endpoint.
Plasma samples were collected from predose to 24 hours postdose for determination of the accumulation ratio of AUC0-24hr. The geometric mean accumulation ratio was calculated as Day 7 AUC0-24hr/Day 1 AUC0-24hr and presented as geometric mean ratio with a full range.
Outcome measures
| Measure |
Part 1: MK-8521 64 μg/Day
n=7 Participants
Type 2 Diabetes Mellitus (T2DM) participants received once daily subcutaneous MK-8521 64 μg/day on Days 1 to 7 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 120 μg/Day
n=8 Participants
T2DM participants received once daily subcutaneous MK-8521 120 μg/day on Days 8 to 14 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 34 μg/Day
T2DM participants received once daily subcutaneous MK-8521 34 μg/day on Days 1 to 7 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: MK-8521 72 μg/Day
T2DM participants received once daily subcutaneous MK-8521 72 μg/day on Days 8 to 14 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: Liraglutide 0.6 mg/Day
T2DM participants received once daily subcutaneous liraglutide 0.6 mg on Day 1 and 2 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.2 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.2 mg on Days 3 to 7 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.8 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.8 mg on Days 8 to 14 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Placebo for MK-8521
T2DM participants received once daily subcutaneous placebo for MK-8521 for 14 days.
|
Part 2: Placebo for MK-8521-T2DM
T2DM participants received once daily subcutaneous placebo for MK-8521 for 29 days.
|
Part 2: MK-8521 64 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 64 µg/day on Days 1 to 7 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
Part 2: MK-8521 120 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 120 µg/day hon Days 8 to 14 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Accumulation Ratio of the Area Under the Concentration-time Curve From 0 to 24 Hours (AUC0-24hr) of MK-8521 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 1
|
2.31 Ratio
Interval 1.85 to 2.66
|
2.50 Ratio
Interval 1.8 to 3.73
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose and 1, 2, 4, 6, 8, 10, 12, 16, and 24 hours post-dose on Days 1 and 7Population: The analysis population included a subset of participants who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment according to the underlying scientific model and had data available for the analysis of the endpoint.
Plasma samples were collected from predose to 24 hours postdose for determination of the accumulation ratio of Cmax. The geometric mean accumulation ratio was calculated as Day 7 Cmax/Day 1 Cmax and presented as geometric mean ratio with a full range.
Outcome measures
| Measure |
Part 1: MK-8521 64 μg/Day
n=7 Participants
Type 2 Diabetes Mellitus (T2DM) participants received once daily subcutaneous MK-8521 64 μg/day on Days 1 to 7 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 120 μg/Day
n=8 Participants
T2DM participants received once daily subcutaneous MK-8521 120 μg/day on Days 8 to 14 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 34 μg/Day
T2DM participants received once daily subcutaneous MK-8521 34 μg/day on Days 1 to 7 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: MK-8521 72 μg/Day
T2DM participants received once daily subcutaneous MK-8521 72 μg/day on Days 8 to 14 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: Liraglutide 0.6 mg/Day
T2DM participants received once daily subcutaneous liraglutide 0.6 mg on Day 1 and 2 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.2 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.2 mg on Days 3 to 7 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.8 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.8 mg on Days 8 to 14 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Placebo for MK-8521
T2DM participants received once daily subcutaneous placebo for MK-8521 for 14 days.
|
Part 2: Placebo for MK-8521-T2DM
T2DM participants received once daily subcutaneous placebo for MK-8521 for 29 days.
|
Part 2: MK-8521 64 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 64 µg/day on Days 1 to 7 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
Part 2: MK-8521 120 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 120 µg/day hon Days 8 to 14 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Accumulation Ratio of the Maximum Concentration (Cmax) of MK-8521 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 1
|
2.00 Ratio
Interval 1.41 to 2.35
|
2.14 Ratio
Interval 1.61 to 2.83
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose on Days 2 and 7Population: The analysis population included a subset of participants who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment according to the underlying scientific model and had data available for the analysis of the endpoint.
Plasma samples were collected predose on Days 2 (sampled after the Day 1 dose and prior to Day 2 dose) and 7 for determination of the accumulation ratio of Ctrough. The geometric mean accumulation ratio was calculated as Day 7 Ctrough/Day 1 Ctrough (sampled after the Day 1 dose and prior to Day 2 dose) and presented as geometric mean ratio with a full range.
Outcome measures
| Measure |
Part 1: MK-8521 64 μg/Day
n=7 Participants
Type 2 Diabetes Mellitus (T2DM) participants received once daily subcutaneous MK-8521 64 μg/day on Days 1 to 7 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 120 μg/Day
n=8 Participants
T2DM participants received once daily subcutaneous MK-8521 120 μg/day on Days 8 to 14 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 34 μg/Day
T2DM participants received once daily subcutaneous MK-8521 34 μg/day on Days 1 to 7 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: MK-8521 72 μg/Day
T2DM participants received once daily subcutaneous MK-8521 72 μg/day on Days 8 to 14 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: Liraglutide 0.6 mg/Day
T2DM participants received once daily subcutaneous liraglutide 0.6 mg on Day 1 and 2 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.2 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.2 mg on Days 3 to 7 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.8 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.8 mg on Days 8 to 14 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Placebo for MK-8521
T2DM participants received once daily subcutaneous placebo for MK-8521 for 14 days.
|
Part 2: Placebo for MK-8521-T2DM
T2DM participants received once daily subcutaneous placebo for MK-8521 for 29 days.
|
Part 2: MK-8521 64 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 64 µg/day on Days 1 to 7 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
Part 2: MK-8521 120 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 120 µg/day hon Days 8 to 14 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Accumulation Ratio of the Trough Concentration (Ctrough) of MK-8521 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 1
|
1.37 Ratio
Interval 0.39 to 2.13
|
1.73 Ratio
Interval 1.46 to 1.93
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose and 1, 2, 6, 10, 16, and 24 hours postdose on Days 1, 7, and 14Population: The analysis population included a subset of participants who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment according to the underlying scientific model and had data available for the analysis of the endpoint.
AUC0-24hr was the area under the concentration-time curve of MK-8521 from time zero to 24 hours after administration. Plasma samples were collected from predose to 24 hours postdose for determination of AUC0-24hr. Individual values were natural log-transformed and evaluated with a linear-mixed effects model containing fixed effects for treatment, day, and treatment by day interaction, and a random effect for participant. Kenward and Roger's method was used to calculate the degree of freedom for the fixed effects. AUC0-24hr is presented as geometric mean and percent coefficient of variation of geometric mean.
Outcome measures
| Measure |
Part 1: MK-8521 64 μg/Day
n=18 Participants
Type 2 Diabetes Mellitus (T2DM) participants received once daily subcutaneous MK-8521 64 μg/day on Days 1 to 7 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 120 μg/Day
n=8 Participants
T2DM participants received once daily subcutaneous MK-8521 120 μg/day on Days 8 to 14 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 34 μg/Day
T2DM participants received once daily subcutaneous MK-8521 34 μg/day on Days 1 to 7 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: MK-8521 72 μg/Day
T2DM participants received once daily subcutaneous MK-8521 72 μg/day on Days 8 to 14 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: Liraglutide 0.6 mg/Day
T2DM participants received once daily subcutaneous liraglutide 0.6 mg on Day 1 and 2 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.2 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.2 mg on Days 3 to 7 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.8 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.8 mg on Days 8 to 14 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Placebo for MK-8521
T2DM participants received once daily subcutaneous placebo for MK-8521 for 14 days.
|
Part 2: Placebo for MK-8521-T2DM
T2DM participants received once daily subcutaneous placebo for MK-8521 for 29 days.
|
Part 2: MK-8521 64 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 64 µg/day on Days 1 to 7 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
Part 2: MK-8521 120 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 120 µg/day hon Days 8 to 14 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve From 0 to 24 Hours (AUC0-24hr) of MK-8521 on Days 1, 7, and 14 for Type 2 Diabetes Mellitus (T2DM) and Non-Diabetic Overweight/Obese Participants in Part 2
Day 7
|
15.1 nM•hour
Geometric Coefficient of Variation 35.6
|
15.0 nM•hour
Geometric Coefficient of Variation 35.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Concentration-time Curve From 0 to 24 Hours (AUC0-24hr) of MK-8521 on Days 1, 7, and 14 for Type 2 Diabetes Mellitus (T2DM) and Non-Diabetic Overweight/Obese Participants in Part 2
Day 14
|
30.0 nM•hour
Geometric Coefficient of Variation 35.8
|
34.4 nM•hour
Geometric Coefficient of Variation 19.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Concentration-time Curve From 0 to 24 Hours (AUC0-24hr) of MK-8521 on Days 1, 7, and 14 for Type 2 Diabetes Mellitus (T2DM) and Non-Diabetic Overweight/Obese Participants in Part 2
Day 1
|
6.46 nM•hour
Geometric Coefficient of Variation 49.5
|
7.68 nM•hour
Geometric Coefficient of Variation 34.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose and 1, 2, 6, 10, 16, and 24 hours post-dose on Days 1 and 7Population: The analysis population included a subset of participants who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment according to the underlying scientific model and had data available for the analysis of the endpoint.
Plasma samples were collected from predose to 24 hours postdose for determination of the accumulation ratio of AUC0-24hr. The geometric mean accumulation ratio was calculated as Day 7 AUC0-24hr/Day 1 AUC0-24hr and presented as geometric mean ratio and percent geometric coefficient of variation.
Outcome measures
| Measure |
Part 1: MK-8521 64 μg/Day
n=18 Participants
Type 2 Diabetes Mellitus (T2DM) participants received once daily subcutaneous MK-8521 64 μg/day on Days 1 to 7 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 120 μg/Day
n=8 Participants
T2DM participants received once daily subcutaneous MK-8521 120 μg/day on Days 8 to 14 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 34 μg/Day
T2DM participants received once daily subcutaneous MK-8521 34 μg/day on Days 1 to 7 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: MK-8521 72 μg/Day
T2DM participants received once daily subcutaneous MK-8521 72 μg/day on Days 8 to 14 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: Liraglutide 0.6 mg/Day
T2DM participants received once daily subcutaneous liraglutide 0.6 mg on Day 1 and 2 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.2 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.2 mg on Days 3 to 7 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.8 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.8 mg on Days 8 to 14 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Placebo for MK-8521
T2DM participants received once daily subcutaneous placebo for MK-8521 for 14 days.
|
Part 2: Placebo for MK-8521-T2DM
T2DM participants received once daily subcutaneous placebo for MK-8521 for 29 days.
|
Part 2: MK-8521 64 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 64 µg/day on Days 1 to 7 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
Part 2: MK-8521 120 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 120 µg/day hon Days 8 to 14 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Accumulation Ratio of the Area Under the Concentration-time Curve From 0 to 24 Hours (AUC0-24hr) of MK-8521 for Type 2 Diabetes Mellitus (T2DM) and Non-Diabetic Overweight/Obese Participants in Part 2
|
2.33 Ratio
Geometric Coefficient of Variation 22.2
|
1.95 Ratio
Geometric Coefficient of Variation 28.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose on Days 1 (baseline) and 7Population: The analysis population included a subset of participants who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment according to the underlying scientific model and had data available for the analysis of the endpoint.
FPG was measured predose on Days 1 and 7. The change from baseline of FPG was calculated as the difference between the predose measurement on Day 1 (baseline) and the measurement obtained predose on Day 7. FPG is presented as mean change from baseline with a standard error.
Outcome measures
| Measure |
Part 1: MK-8521 64 μg/Day
n=7 Participants
Type 2 Diabetes Mellitus (T2DM) participants received once daily subcutaneous MK-8521 64 μg/day on Days 1 to 7 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 120 μg/Day
n=8 Participants
T2DM participants received once daily subcutaneous MK-8521 120 μg/day on Days 8 to 14 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 34 μg/Day
n=9 Participants
T2DM participants received once daily subcutaneous MK-8521 34 μg/day on Days 1 to 7 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: MK-8521 72 μg/Day
n=8 Participants
T2DM participants received once daily subcutaneous MK-8521 72 μg/day on Days 8 to 14 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: Liraglutide 0.6 mg/Day
T2DM participants received once daily subcutaneous liraglutide 0.6 mg on Day 1 and 2 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.2 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.2 mg on Days 3 to 7 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.8 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.8 mg on Days 8 to 14 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Placebo for MK-8521
T2DM participants received once daily subcutaneous placebo for MK-8521 for 14 days.
|
Part 2: Placebo for MK-8521-T2DM
T2DM participants received once daily subcutaneous placebo for MK-8521 for 29 days.
|
Part 2: MK-8521 64 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 64 µg/day on Days 1 to 7 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
Part 2: MK-8521 120 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 120 µg/day hon Days 8 to 14 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Day 7 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 1
|
-23.57 mg/dL
Standard Error 10.75
|
-39.00 mg/dL
Standard Error 8.44
|
-59.11 mg/dL
Standard Error 7.09
|
-11.13 mg/dL
Standard Error 7.26
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose on Days 1 (baseline) and 14Population: The analysis population included a subset of participants who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment according to the underlying scientific model and had data available for the analysis of the endpoint.
FPG was measured predose on Days 1 and 14. The change from baseline of FPG was calculated as the difference between the predose measurement on Day 1 (baseline) and the measurement obtained predose on Day 14. FPG is presented as mean change from baseline with a standard error.
Outcome measures
| Measure |
Part 1: MK-8521 64 μg/Day
n=7 Participants
Type 2 Diabetes Mellitus (T2DM) participants received once daily subcutaneous MK-8521 64 μg/day on Days 1 to 7 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 120 μg/Day
n=8 Participants
T2DM participants received once daily subcutaneous MK-8521 120 μg/day on Days 8 to 14 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 34 μg/Day
n=8 Participants
T2DM participants received once daily subcutaneous MK-8521 34 μg/day on Days 1 to 7 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: MK-8521 72 μg/Day
n=8 Participants
T2DM participants received once daily subcutaneous MK-8521 72 μg/day on Days 8 to 14 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: Liraglutide 0.6 mg/Day
T2DM participants received once daily subcutaneous liraglutide 0.6 mg on Day 1 and 2 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.2 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.2 mg on Days 3 to 7 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.8 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.8 mg on Days 8 to 14 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Placebo for MK-8521
T2DM participants received once daily subcutaneous placebo for MK-8521 for 14 days.
|
Part 2: Placebo for MK-8521-T2DM
T2DM participants received once daily subcutaneous placebo for MK-8521 for 29 days.
|
Part 2: MK-8521 64 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 64 µg/day on Days 1 to 7 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
Part 2: MK-8521 120 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 120 µg/day hon Days 8 to 14 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Day 14 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 1
|
-41.29 mg/dL
Standard Error 11.22
|
-48.50 mg/dL
Standard Error 13.21
|
-59.25 mg/dL
Standard Error 4.98
|
-13.50 mg/dL
Standard Error 9.54
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (predose and before food on Day 1) and up to 24 hours post Day 7 dosePopulation: The analysis population included a subset of participants who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment according to the underlying scientific model and had data available for the analysis of the endpoint.
The 24-hour WMG was calculated as the area under the 24-hour glucose curve (AUC0-24hr) divided by 24 hours. Blood samples for glucose were collected immediately prior to, and after each meal. The change from baseline value for 24-hour WMG was calculated where baseline was the WMG before food and prior to treatment on Day 1. Blood for plasma glucose concentrations was obtained at predose Day 1 at pre meal (breakfast), 0.5, 1, 2, 3, 4 (pre lunch), 4.5, 5, 6, 7, 10 (pre dinner), 10.5, 11, 12, 13, 15 and 23 hours post breakfast meal; and on Day 7 at 1 (pre breakfast), 1.5, 2, 3, 4, 5 (pre lunch), 5.5, 6, 7, 8, 11 (pre dinner), 11.5, 12, 13, 14, 16, 24 hours post dose. Individual change from baseline 24-hour WMG was analyzed in a linear mixed effects model with fixed effects for treatment, day and treatment by day interaction, a random effect for participant, and baseline 24-hour WMG as a covariate. WMG is presented as least squares mean with a 95% confidence interval.
Outcome measures
| Measure |
Part 1: MK-8521 64 μg/Day
n=6 Participants
Type 2 Diabetes Mellitus (T2DM) participants received once daily subcutaneous MK-8521 64 μg/day on Days 1 to 7 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 120 μg/Day
n=8 Participants
T2DM participants received once daily subcutaneous MK-8521 120 μg/day on Days 8 to 14 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 34 μg/Day
n=6 Participants
T2DM participants received once daily subcutaneous MK-8521 34 μg/day on Days 1 to 7 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: MK-8521 72 μg/Day
n=8 Participants
T2DM participants received once daily subcutaneous MK-8521 72 μg/day on Days 8 to 14 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: Liraglutide 0.6 mg/Day
T2DM participants received once daily subcutaneous liraglutide 0.6 mg on Day 1 and 2 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.2 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.2 mg on Days 3 to 7 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.8 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.8 mg on Days 8 to 14 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Placebo for MK-8521
T2DM participants received once daily subcutaneous placebo for MK-8521 for 14 days.
|
Part 2: Placebo for MK-8521-T2DM
T2DM participants received once daily subcutaneous placebo for MK-8521 for 29 days.
|
Part 2: MK-8521 64 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 64 µg/day on Days 1 to 7 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
Part 2: MK-8521 120 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 120 µg/day hon Days 8 to 14 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in 24-hour Weighted Mean Glucose (WMG) at Day 7 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 1
|
-24.08 mg/dL
Interval -45.46 to -2.71
|
-27.54 mg/dL
Interval -46.39 to -8.69
|
-53.64 mg/dL
Interval -75.2 to -32.08
|
2.36 mg/dL
Interval -16.2 to 20.92
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (predose and before food on Day 1) and up to 24 hours post Day 14 dosePopulation: The analysis population included a subset of participants who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment according to the underlying scientific model and had data available for the analysis of the endpoint.
The 24-hour WMG was calculated as the area under the 24-hour glucose curve (AUC0-24hr) divided by 24 hours. Blood samples for glucose were collected immediately prior to and after each meal. The change from baseline value for 24-hour WMG was calculated where baseline was the WMG before food and prior to treatment on Day 1. Blood for plasma glucose concentrations was obtained on Day -1 at pre meal (breakfast), 0.5, 1, 2, 3, 4 (pre lunch), 4.5, 5, 6, 7, 10 (pre dinner), 10.5, 11, 12, 13, 15 and 23 hours post breakfast meal; and on Day 14 at 1 (pre breakfast), 1.5, 2, 3, 4, 5 (pre lunch), 5.5, 6, 7, 8, 11(pre dinner), 11.5, 12, 13, 14, 16, 24 hours post dose. Individual change from baseline 24-hour WMG was analyzed in a linear mixed effects model with fixed effects for treatment, day and treatment by day interaction, a random effect for participant, and baseline 24-hour WMG as a covariate. WMG is presented as least squares mean with a 95% confidence interval.
Outcome measures
| Measure |
Part 1: MK-8521 64 μg/Day
n=6 Participants
Type 2 Diabetes Mellitus (T2DM) participants received once daily subcutaneous MK-8521 64 μg/day on Days 1 to 7 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 120 μg/Day
n=8 Participants
T2DM participants received once daily subcutaneous MK-8521 120 μg/day on Days 8 to 14 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 34 μg/Day
n=6 Participants
T2DM participants received once daily subcutaneous MK-8521 34 μg/day on Days 1 to 7 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: MK-8521 72 μg/Day
n=8 Participants
T2DM participants received once daily subcutaneous MK-8521 72 μg/day on Days 8 to 14 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: Liraglutide 0.6 mg/Day
T2DM participants received once daily subcutaneous liraglutide 0.6 mg on Day 1 and 2 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.2 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.2 mg on Days 3 to 7 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.8 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.8 mg on Days 8 to 14 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Placebo for MK-8521
T2DM participants received once daily subcutaneous placebo for MK-8521 for 14 days.
|
Part 2: Placebo for MK-8521-T2DM
T2DM participants received once daily subcutaneous placebo for MK-8521 for 29 days.
|
Part 2: MK-8521 64 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 64 µg/day on Days 1 to 7 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
Part 2: MK-8521 120 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 120 µg/day hon Days 8 to 14 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in 24-hour Weighted Mean Glucose (WMG) at Day 14 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 1
|
-37.24 mg/dL
Interval -58.61 to -15.86
|
-45.63 mg/dL
Interval -64.49 to -26.78
|
-52.20 mg/dL
Interval -73.76 to -30.64
|
-2.00 mg/dL
Interval -20.56 to 16.56
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose on Days 1 (baseline) and 14Population: The analysis population included a subset of participants who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment according to the underlying scientific model and had data available for the analysis of the endpoint.
FPG was measured predose on Days 1 and 14. The change from baseline of FPG was calculated as the difference between the predose measurement on Day 1 (baseline) and the measurement obtained predose on Day 14. FPG is presented as least squares mean change from baseline with a 95% confidence interval.
Outcome measures
| Measure |
Part 1: MK-8521 64 μg/Day
n=18 Participants
Type 2 Diabetes Mellitus (T2DM) participants received once daily subcutaneous MK-8521 64 μg/day on Days 1 to 7 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 120 μg/Day
n=13 Participants
T2DM participants received once daily subcutaneous MK-8521 120 μg/day on Days 8 to 14 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 34 μg/Day
n=5 Participants
T2DM participants received once daily subcutaneous MK-8521 34 μg/day on Days 1 to 7 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: MK-8521 72 μg/Day
T2DM participants received once daily subcutaneous MK-8521 72 μg/day on Days 8 to 14 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: Liraglutide 0.6 mg/Day
T2DM participants received once daily subcutaneous liraglutide 0.6 mg on Day 1 and 2 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.2 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.2 mg on Days 3 to 7 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.8 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.8 mg on Days 8 to 14 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Placebo for MK-8521
T2DM participants received once daily subcutaneous placebo for MK-8521 for 14 days.
|
Part 2: Placebo for MK-8521-T2DM
T2DM participants received once daily subcutaneous placebo for MK-8521 for 29 days.
|
Part 2: MK-8521 64 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 64 µg/day on Days 1 to 7 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
Part 2: MK-8521 120 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 120 µg/day hon Days 8 to 14 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Day 14 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 2
|
-45.89 mg/dL
Interval -56.44 to -35.33
|
-39.80 mg/dL
Interval -48.27 to -31.33
|
-14.69 mg/dL
Interval -43.93 to 14.55
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose on Days 1 (baseline) and 19Population: The analysis population included a subset of participants who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment according to the underlying scientific model and had data available for the analysis of the endpoint.
FPG was measured predose on Days 1 and 19. The change from baseline of FPG was calculated as the difference between the predose measurement on Day 1 (baseline) and the measurement obtained predose on Day 19. FPG is presented as least squares mean change from baseline with a 95% confidence interval.
Outcome measures
| Measure |
Part 1: MK-8521 64 μg/Day
n=18 Participants
Type 2 Diabetes Mellitus (T2DM) participants received once daily subcutaneous MK-8521 64 μg/day on Days 1 to 7 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 120 μg/Day
n=13 Participants
T2DM participants received once daily subcutaneous MK-8521 120 μg/day on Days 8 to 14 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 34 μg/Day
n=5 Participants
T2DM participants received once daily subcutaneous MK-8521 34 μg/day on Days 1 to 7 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: MK-8521 72 μg/Day
T2DM participants received once daily subcutaneous MK-8521 72 μg/day on Days 8 to 14 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: Liraglutide 0.6 mg/Day
T2DM participants received once daily subcutaneous liraglutide 0.6 mg on Day 1 and 2 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.2 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.2 mg on Days 3 to 7 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.8 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.8 mg on Days 8 to 14 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Placebo for MK-8521
T2DM participants received once daily subcutaneous placebo for MK-8521 for 14 days.
|
Part 2: Placebo for MK-8521-T2DM
T2DM participants received once daily subcutaneous placebo for MK-8521 for 29 days.
|
Part 2: MK-8521 64 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 64 µg/day on Days 1 to 7 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
Part 2: MK-8521 120 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 120 µg/day hon Days 8 to 14 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Day 19 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 2
|
-44.22 mg/dL
Interval -54.77 to -33.66
|
-47.33 mg/dL
Interval -55.8 to -38.86
|
-16.74 mg/dL
Interval -45.98 to 12.51
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose on Days 1 (baseline) and 24Population: The analysis population included a subset of participants who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment according to the underlying scientific model and had data available for the analysis of the endpoint.
FPG was measured predose on Days 1 and 24. The change from baseline of FPG was calculated as the difference between the predose measurement on Day 1 (baseline) and the measurement obtained predose on Day 24. FPG is presented as least squares mean change from baseline with a 95% confidence interval.
Outcome measures
| Measure |
Part 1: MK-8521 64 μg/Day
n=17 Participants
Type 2 Diabetes Mellitus (T2DM) participants received once daily subcutaneous MK-8521 64 μg/day on Days 1 to 7 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 120 μg/Day
n=11 Participants
T2DM participants received once daily subcutaneous MK-8521 120 μg/day on Days 8 to 14 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 34 μg/Day
n=5 Participants
T2DM participants received once daily subcutaneous MK-8521 34 μg/day on Days 1 to 7 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: MK-8521 72 μg/Day
T2DM participants received once daily subcutaneous MK-8521 72 μg/day on Days 8 to 14 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: Liraglutide 0.6 mg/Day
T2DM participants received once daily subcutaneous liraglutide 0.6 mg on Day 1 and 2 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.2 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.2 mg on Days 3 to 7 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.8 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.8 mg on Days 8 to 14 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Placebo for MK-8521
T2DM participants received once daily subcutaneous placebo for MK-8521 for 14 days.
|
Part 2: Placebo for MK-8521-T2DM
T2DM participants received once daily subcutaneous placebo for MK-8521 for 29 days.
|
Part 2: MK-8521 64 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 64 µg/day on Days 1 to 7 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
Part 2: MK-8521 120 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 120 µg/day hon Days 8 to 14 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Day 24 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 2
|
-40.14 mg/dL
Interval -51.0 to -29.27
|
-50.14 mg/dL
Interval -59.3 to -40.99
|
-44.73 mg/dL
Interval -73.97 to -15.49
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose on Days 1 (baseline) and 29Population: The analysis population included a subset of participants who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment according to the underlying scientific model and had data available for the analysis of the endpoint.
FPG was measured predose on Days 1 and 29. The change from baseline of FPG was calculated as the difference between the predose measurement on Day 1 (baseline) and the measurement obtained predose on Day 29. FPG is presented as least squares mean change from baseline with a 95% confidence interval.
Outcome measures
| Measure |
Part 1: MK-8521 64 μg/Day
n=16 Participants
Type 2 Diabetes Mellitus (T2DM) participants received once daily subcutaneous MK-8521 64 μg/day on Days 1 to 7 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 120 μg/Day
n=11 Participants
T2DM participants received once daily subcutaneous MK-8521 120 μg/day on Days 8 to 14 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 34 μg/Day
n=5 Participants
T2DM participants received once daily subcutaneous MK-8521 34 μg/day on Days 1 to 7 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: MK-8521 72 μg/Day
T2DM participants received once daily subcutaneous MK-8521 72 μg/day on Days 8 to 14 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: Liraglutide 0.6 mg/Day
T2DM participants received once daily subcutaneous liraglutide 0.6 mg on Day 1 and 2 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.2 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.2 mg on Days 3 to 7 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.8 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.8 mg on Days 8 to 14 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Placebo for MK-8521
T2DM participants received once daily subcutaneous placebo for MK-8521 for 14 days.
|
Part 2: Placebo for MK-8521-T2DM
T2DM participants received once daily subcutaneous placebo for MK-8521 for 29 days.
|
Part 2: MK-8521 64 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 64 µg/day on Days 1 to 7 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
Part 2: MK-8521 120 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 120 µg/day hon Days 8 to 14 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Day 29 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 2
|
-52.54 mg/dL
Interval -63.74 to -41.33
|
-52.06 mg/dL
Interval -61.21 to -42.91
|
-37.55 mg/dL
Interval -66.8 to -8.31
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (predose and before food on Day 1) and up to 24 hours post Day 14 dosePopulation: The analysis population included a subset of participants who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment according to the underlying scientific model and had data available for the analysis of the endpoint.
The 24-hour WMG was calculated as the area under the 24-hour glucose curve (AUC0-24hr) divided by 24 hours. Plasma glucose concentrations were obtained on Day -1 at pre meal (breakfast), 1, 3, 4 (pre lunch), 5, 7, 10 (pre dinner), 11, 13, 15 and 23 hours post breakfast meal and Day 14 at 1 (pre breakfast), 2, 4, 5 (pre lunch), 6, 8, 11 (pre dinner), 12, 14, 16, 24 hours post dose. The timing of samples on Day -1 are relative to the breakfast meal. Day 14 samples are relative to dosing. The change from baseline value for 24-hour WMG was calculated where baseline was the WMG before food and prior to treatment on Day 1. Individual change from baseline 24-hour WMG was analyzed in a linear mixed effects model with group, day and group by day interaction as fixed effects, baseline 24-hour WMG as a covariate, and participant as a random effect. WMG is presented as least squares mean with a 95% confidence interval.
Outcome measures
| Measure |
Part 1: MK-8521 64 μg/Day
n=18 Participants
Type 2 Diabetes Mellitus (T2DM) participants received once daily subcutaneous MK-8521 64 μg/day on Days 1 to 7 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 120 μg/Day
n=13 Participants
T2DM participants received once daily subcutaneous MK-8521 120 μg/day on Days 8 to 14 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 34 μg/Day
n=5 Participants
T2DM participants received once daily subcutaneous MK-8521 34 μg/day on Days 1 to 7 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: MK-8521 72 μg/Day
T2DM participants received once daily subcutaneous MK-8521 72 μg/day on Days 8 to 14 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: Liraglutide 0.6 mg/Day
T2DM participants received once daily subcutaneous liraglutide 0.6 mg on Day 1 and 2 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.2 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.2 mg on Days 3 to 7 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.8 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.8 mg on Days 8 to 14 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Placebo for MK-8521
T2DM participants received once daily subcutaneous placebo for MK-8521 for 14 days.
|
Part 2: Placebo for MK-8521-T2DM
T2DM participants received once daily subcutaneous placebo for MK-8521 for 29 days.
|
Part 2: MK-8521 64 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 64 µg/day on Days 1 to 7 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
Part 2: MK-8521 120 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 120 µg/day hon Days 8 to 14 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in 24-hour Weighted Mean Glucose (WMG) at Day 14 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 2
|
-47.52 mg/dL
Interval -56.82 to -38.22
|
-51.24 mg/dL
Interval -58.02 to -44.45
|
-3.84 mg/dL
Interval -30.31 to 22.63
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (predose and before food on Day 1) and up to 24 hours post Day 19 dosePopulation: The analysis population included a subset of participants who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment according to the underlying scientific model and had data available for the analysis of the endpoint.
The 24-hour WMG was calculated as the area under the 24-hour glucose curve (AUC0-24hr) divided by 24 hours. Plasma glucose concentrations were obtained on Day -1 at pre meal (breakfast), 1, 3, 4 (pre lunch), 5, 7, 10 (pre dinner), 11, 13, 15 and 23 hours post breakfast meal and Day 19 at 1 (pre breakfast), 2, 4, 5 (pre lunch), 6, 8, 11 (pre dinner), 12, 14, 16, 24 hours post dose. The timing of samples on Day -1 are relative to the breakfast meal. Day 19 samples are relative to dosing. The change from baseline value for 24-hour WMG was calculated where baseline was the WMG before food and prior to treatment on Day 1. Individual change from baseline 24-hour WMG was analyzed in a linear mixed effects model with group, day and group by day interaction as fixed effects, baseline 24-hour WMG as a covariate, and participant as a random effect. WMG is presented as least squares mean with a 95% confidence interval.
Outcome measures
| Measure |
Part 1: MK-8521 64 μg/Day
n=18 Participants
Type 2 Diabetes Mellitus (T2DM) participants received once daily subcutaneous MK-8521 64 μg/day on Days 1 to 7 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 120 μg/Day
n=13 Participants
T2DM participants received once daily subcutaneous MK-8521 120 μg/day on Days 8 to 14 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 34 μg/Day
n=5 Participants
T2DM participants received once daily subcutaneous MK-8521 34 μg/day on Days 1 to 7 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: MK-8521 72 μg/Day
T2DM participants received once daily subcutaneous MK-8521 72 μg/day on Days 8 to 14 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: Liraglutide 0.6 mg/Day
T2DM participants received once daily subcutaneous liraglutide 0.6 mg on Day 1 and 2 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.2 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.2 mg on Days 3 to 7 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.8 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.8 mg on Days 8 to 14 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Placebo for MK-8521
T2DM participants received once daily subcutaneous placebo for MK-8521 for 14 days.
|
Part 2: Placebo for MK-8521-T2DM
T2DM participants received once daily subcutaneous placebo for MK-8521 for 29 days.
|
Part 2: MK-8521 64 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 64 µg/day on Days 1 to 7 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
Part 2: MK-8521 120 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 120 µg/day hon Days 8 to 14 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in 24-hour Weighted Mean Glucose (WMG) at Day 19 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 2
|
-52.23 mg/dL
Interval -61.54 to -42.93
|
-57.43 mg/dL
Interval -64.21 to -50.64
|
-18.22 mg/dL
Interval -44.69 to 8.25
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (predose and before food on Day 1) and up to 24 hours post Day 24 dosePopulation: The analysis population included a subset of participants who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment according to the underlying scientific model and had data available for the analysis of the endpoint.
The 24-hour WMG was calculated as the area under the 24-hour glucose curve (AUC0-24hr) divided by 24 hours. Plasma glucose concentrations were obtained on Day -1 at pre meal (breakfast), 1, 3, 4 (pre lunch), 5, 7, 10 (pre dinner), 11, 13, 15 and 23 hours post breakfast meal and Day 24 at 1 (pre breakfast), 2, 4, 5 (pre lunch), 6, 8, 11 (pre dinner), 12, 14, 16, 24 hours post dose. The timing of samples on Day -1 are relative to the breakfast meal. Day 24 samples are relative to dosing. The change from baseline value for 24-hour WMG was calculated where baseline was the WMG before food and prior to treatment on Day 1. Individual change from baseline 24-hour WMG was analyzed in a linear mixed effects model with group, day and group by day interaction as fixed effects, baseline 24-hour WMG as a covariate, and participant as a random effect. WMG is presented as least squares mean with a 95% confidence interval.
Outcome measures
| Measure |
Part 1: MK-8521 64 μg/Day
n=16 Participants
Type 2 Diabetes Mellitus (T2DM) participants received once daily subcutaneous MK-8521 64 μg/day on Days 1 to 7 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 120 μg/Day
n=11 Participants
T2DM participants received once daily subcutaneous MK-8521 120 μg/day on Days 8 to 14 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 34 μg/Day
n=5 Participants
T2DM participants received once daily subcutaneous MK-8521 34 μg/day on Days 1 to 7 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: MK-8521 72 μg/Day
T2DM participants received once daily subcutaneous MK-8521 72 μg/day on Days 8 to 14 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: Liraglutide 0.6 mg/Day
T2DM participants received once daily subcutaneous liraglutide 0.6 mg on Day 1 and 2 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.2 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.2 mg on Days 3 to 7 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.8 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.8 mg on Days 8 to 14 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Placebo for MK-8521
T2DM participants received once daily subcutaneous placebo for MK-8521 for 14 days.
|
Part 2: Placebo for MK-8521-T2DM
T2DM participants received once daily subcutaneous placebo for MK-8521 for 29 days.
|
Part 2: MK-8521 64 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 64 µg/day on Days 1 to 7 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
Part 2: MK-8521 120 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 120 µg/day hon Days 8 to 14 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in 24-hour Weighted Mean Glucose (WMG) at Day 24 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 2
|
-50.44 mg/dL
Interval -59.89 to -40.99
|
-60.66 mg/dL
Interval -67.6 to -53.72
|
-26.71 mg/dL
Interval -53.18 to -0.24
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (predose and before food on Day 1) and up to 24 hours post Day 29 dosePopulation: The analysis population included a subset of participants who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment according to the underlying scientific model and had data available for the analysis of the endpoint.
The 24-hour WMG was calculated as the area under the 24-hour glucose curve (AUC0-24hr) divided by 24 hours. Plasma glucose concentrations were obtained on Day -1 at pre meal (breakfast), 1, 3, 4 (pre lunch), 5, 7, 10 (pre dinner), 11, 13, 15 and 23 hours post breakfast meal and Day 29 at 1 (pre breakfast), 2, 4, 5 (pre lunch), 6, 8, 11 (pre dinner), 12, 14, 16, 24 hours post dose. The timing of samples on Day -1 are relative to the breakfast meal. Day 29 samples are relative to dosing. The change from baseline value for 24-hour WMG was calculated where baseline was the WMG before food and prior to treatment on Day 1. Individual change from baseline 24-hour WMG was analyzed in a linear mixed effects model with group, day and group by day interaction as fixed effects, baseline 24-hour WMG as a covariate, and participant as a random effect. WMG is presented as least squares mean with a 95% confidence interval.
Outcome measures
| Measure |
Part 1: MK-8521 64 μg/Day
n=16 Participants
Type 2 Diabetes Mellitus (T2DM) participants received once daily subcutaneous MK-8521 64 μg/day on Days 1 to 7 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 120 μg/Day
n=11 Participants
T2DM participants received once daily subcutaneous MK-8521 120 μg/day on Days 8 to 14 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 34 μg/Day
n=5 Participants
T2DM participants received once daily subcutaneous MK-8521 34 μg/day on Days 1 to 7 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: MK-8521 72 μg/Day
T2DM participants received once daily subcutaneous MK-8521 72 μg/day on Days 8 to 14 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: Liraglutide 0.6 mg/Day
T2DM participants received once daily subcutaneous liraglutide 0.6 mg on Day 1 and 2 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.2 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.2 mg on Days 3 to 7 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.8 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.8 mg on Days 8 to 14 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Placebo for MK-8521
T2DM participants received once daily subcutaneous placebo for MK-8521 for 14 days.
|
Part 2: Placebo for MK-8521-T2DM
T2DM participants received once daily subcutaneous placebo for MK-8521 for 29 days.
|
Part 2: MK-8521 64 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 64 µg/day on Days 1 to 7 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
Part 2: MK-8521 120 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 120 µg/day hon Days 8 to 14 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in 24-hour Weighted Mean Glucose (WMG) at Day 29 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 2
|
-53.44 mg/dL
Interval -62.89 to -43.99
|
-59.72 mg/dL
Interval -66.66 to -52.78
|
-29.96 mg/dL
Interval -56.43 to -3.49
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose and 1, 2, 6, 10, 16, 24 hours post dose on Days 1, 7, 14, 19, 24 (T2DM) and Days 1 and 7 (Non-Diabetic Overweight/Obese); predose and 1, 2, 6, 10, 16, 24, 72, 96. and 120 hours post dose on Day 14 (Non-Diabetic Overweight/Obese) and Day 29 (T2DM).Population: The analysis population included a subset of participants who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment according to the underlying scientific model and had data available for the analysis of the endpoint.
Cmax was the maximum observed concentration of MK-8521 in plasma after administration. Plasma samples were collected from predose to 120 hours postdose for determination of Cmax. Per protocol, Cmax in the non-diabetic overweight/obese participants was not measured on Days 19, 24, and 29 because they only received 14 days of treatment. Individual values were natural log-transformed and evaluated with a linear-mixed effects model containing fixed effects for treatment, day, and treatment by day interaction, and a random effect for participant. Kenward and Roger's method was used to calculate the degree of freedom for the fixed effects. Cmax is presented as geometric mean and percent coefficient of variation of geometric mean.
Outcome measures
| Measure |
Part 1: MK-8521 64 μg/Day
n=18 Participants
Type 2 Diabetes Mellitus (T2DM) participants received once daily subcutaneous MK-8521 64 μg/day on Days 1 to 7 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 120 μg/Day
n=8 Participants
T2DM participants received once daily subcutaneous MK-8521 120 μg/day on Days 8 to 14 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 34 μg/Day
T2DM participants received once daily subcutaneous MK-8521 34 μg/day on Days 1 to 7 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: MK-8521 72 μg/Day
T2DM participants received once daily subcutaneous MK-8521 72 μg/day on Days 8 to 14 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: Liraglutide 0.6 mg/Day
T2DM participants received once daily subcutaneous liraglutide 0.6 mg on Day 1 and 2 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.2 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.2 mg on Days 3 to 7 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.8 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.8 mg on Days 8 to 14 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Placebo for MK-8521
T2DM participants received once daily subcutaneous placebo for MK-8521 for 14 days.
|
Part 2: Placebo for MK-8521-T2DM
T2DM participants received once daily subcutaneous placebo for MK-8521 for 29 days.
|
Part 2: MK-8521 64 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 64 µg/day on Days 1 to 7 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
Part 2: MK-8521 120 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 120 µg/day hon Days 8 to 14 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Concentration (Cmax) of MK-8521 for Type 2 Diabetes Mellitus (T2DM) and Non-Diabetic Overweight/Obese Participants in Part 2
Day 1
|
0.35 nM
Geometric Coefficient of Variation 48.0
|
0.411 nM
Geometric Coefficient of Variation 32.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Concentration (Cmax) of MK-8521 for Type 2 Diabetes Mellitus (T2DM) and Non-Diabetic Overweight/Obese Participants in Part 2
Day 24
|
2.85 nM
Geometric Coefficient of Variation 33.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Concentration (Cmax) of MK-8521 for Type 2 Diabetes Mellitus (T2DM) and Non-Diabetic Overweight/Obese Participants in Part 2
Day 7
|
0.719 nM
Geometric Coefficient of Variation 34.6
|
0.742 nM
Geometric Coefficient of Variation 38.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Concentration (Cmax) of MK-8521 for Type 2 Diabetes Mellitus (T2DM) and Non-Diabetic Overweight/Obese Participants in Part 2
Day 14
|
1.43 nM
Geometric Coefficient of Variation 35.8
|
1.72 nM
Geometric Coefficient of Variation 20.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Concentration (Cmax) of MK-8521 for Type 2 Diabetes Mellitus (T2DM) and Non-Diabetic Overweight/Obese Participants in Part 2
Day 19
|
2.27 nM
Geometric Coefficient of Variation 38.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Concentration (Cmax) of MK-8521 for Type 2 Diabetes Mellitus (T2DM) and Non-Diabetic Overweight/Obese Participants in Part 2
Day 29
|
3.14 nM
Geometric Coefficient of Variation 34.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose on Days 2 (sampled 24 hours after Day 1 dose) and 7, 14, 19, 24, and 29Population: The analysis population included a subset of participants who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment according to the underlying scientific model and had data available for the analysis of the endpoint.
Ctrough was the lowest observed concentration of MK-8521 in plasma. Plasma samples were collected predose on Day 2 (sampled after the Day 1 dose and prior to Day 2 dose), 7, 14, 19, 24, and 29 for determination of Ctrough. Per protocol, Ctrough in the non-diabetic overweight/obese participants was not measured on Days 19, 24, and 29 because they only received 14 days of treatment. Individual values were natural log-transformed and evaluated with a linear-mixed effects model containing fixed effects for treatment, day, and treatment by day interaction, and a random effect for participant. Kenward and Roger's method was used to calculate the degree of freedom for the fixed effects. Ctrough is presented as geometric mean and percent coefficient of variation of geometric mean.
Outcome measures
| Measure |
Part 1: MK-8521 64 μg/Day
n=18 Participants
Type 2 Diabetes Mellitus (T2DM) participants received once daily subcutaneous MK-8521 64 μg/day on Days 1 to 7 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 120 μg/Day
n=8 Participants
T2DM participants received once daily subcutaneous MK-8521 120 μg/day on Days 8 to 14 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 34 μg/Day
T2DM participants received once daily subcutaneous MK-8521 34 μg/day on Days 1 to 7 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: MK-8521 72 μg/Day
T2DM participants received once daily subcutaneous MK-8521 72 μg/day on Days 8 to 14 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: Liraglutide 0.6 mg/Day
T2DM participants received once daily subcutaneous liraglutide 0.6 mg on Day 1 and 2 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.2 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.2 mg on Days 3 to 7 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.8 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.8 mg on Days 8 to 14 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Placebo for MK-8521
T2DM participants received once daily subcutaneous placebo for MK-8521 for 14 days.
|
Part 2: Placebo for MK-8521-T2DM
T2DM participants received once daily subcutaneous placebo for MK-8521 for 29 days.
|
Part 2: MK-8521 64 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 64 µg/day on Days 1 to 7 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
Part 2: MK-8521 120 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 120 µg/day hon Days 8 to 14 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Trough Concentration (Ctrough) of MK-8521 for Type 2 Diabetes Mellitus (T2DM) and Non-Diabetic Overweight/Obese Participants in Part 2
Day 19
|
1.61 nM
Geometric Coefficient of Variation 33.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Trough Concentration (Ctrough) of MK-8521 for Type 2 Diabetes Mellitus (T2DM) and Non-Diabetic Overweight/Obese Participants in Part 2
Day 7
|
0.533 nM
Geometric Coefficient of Variation 32.7
|
0.492 nM
Geometric Coefficient of Variation 29.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Trough Concentration (Ctrough) of MK-8521 for Type 2 Diabetes Mellitus (T2DM) and Non-Diabetic Overweight/Obese Participants in Part 2
Day 14
|
1.07 nM
Geometric Coefficient of Variation 36.0
|
1.12 nM
Geometric Coefficient of Variation 21.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Trough Concentration (Ctrough) of MK-8521 for Type 2 Diabetes Mellitus (T2DM) and Non-Diabetic Overweight/Obese Participants in Part 2
Day 24
|
2.02 nM
Geometric Coefficient of Variation 30.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Trough Concentration (Ctrough) of MK-8521 for Type 2 Diabetes Mellitus (T2DM) and Non-Diabetic Overweight/Obese Participants in Part 2
Day 29
|
2.47 nM
Geometric Coefficient of Variation 29.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Trough Concentration (Ctrough) of MK-8521 for Type 2 Diabetes Mellitus (T2DM) and Non-Diabetic Overweight/Obese Participants in Part 2
Day 1
|
0.331 nM
Geometric Coefficient of Variation 45.5
|
0.388 nM
Geometric Coefficient of Variation 32.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose and 1, 2, 6, 10, 16, 24 hours post dose on Days 1, 7, 14, 19, 24 (T2DM) and Days 1 and 7 (Non-Diabetic Overweight/Obese); predose and 1, 2, 6, 10, 16, 24, 72, 96. and 120 hours post dose on Day 14 (Non-Diabetic Overweight/Obese) and Day 29 (T2DM).Population: The analysis population included a subset of participants who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment according to the underlying scientific model and had data available for the analysis of the endpoint.
Tmax was the time required to reach the maximum concentration of MK-8521 in plasma. Plasma samples were collected from predose to 120 hours postdose for determination of Tmax. Per protocol, Tmax in the non-diabetic overweight/obese participants was not measured on Days 19, 24, and 29 because they only received 14 days of treatment. Tmax is presented as median with a full range.
Outcome measures
| Measure |
Part 1: MK-8521 64 μg/Day
n=18 Participants
Type 2 Diabetes Mellitus (T2DM) participants received once daily subcutaneous MK-8521 64 μg/day on Days 1 to 7 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 120 μg/Day
n=8 Participants
T2DM participants received once daily subcutaneous MK-8521 120 μg/day on Days 8 to 14 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 34 μg/Day
T2DM participants received once daily subcutaneous MK-8521 34 μg/day on Days 1 to 7 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: MK-8521 72 μg/Day
T2DM participants received once daily subcutaneous MK-8521 72 μg/day on Days 8 to 14 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: Liraglutide 0.6 mg/Day
T2DM participants received once daily subcutaneous liraglutide 0.6 mg on Day 1 and 2 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.2 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.2 mg on Days 3 to 7 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.8 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.8 mg on Days 8 to 14 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Placebo for MK-8521
T2DM participants received once daily subcutaneous placebo for MK-8521 for 14 days.
|
Part 2: Placebo for MK-8521-T2DM
T2DM participants received once daily subcutaneous placebo for MK-8521 for 29 days.
|
Part 2: MK-8521 64 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 64 µg/day on Days 1 to 7 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
Part 2: MK-8521 120 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 120 µg/day hon Days 8 to 14 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Maximum Concentration (Tmax) of MK-8521 for Type 2 Diabetes Mellitus (T2DM) and Non-Diabetic Overweight/Obese Participants in Part 2
Day 29
|
10 Hours
Interval 1.0 to 24.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time to Maximum Concentration (Tmax) of MK-8521 for Type 2 Diabetes Mellitus (T2DM) and Non-Diabetic Overweight/Obese Participants in Part 2
Day 1
|
16 Hours
Interval 10.0 to 24.0
|
16 Hours
Interval 10.0 to 24.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time to Maximum Concentration (Tmax) of MK-8521 for Type 2 Diabetes Mellitus (T2DM) and Non-Diabetic Overweight/Obese Participants in Part 2
Day 7
|
10 Hours
Interval 1.0 to 16.0
|
10 Hours
Interval 10.0 to 10.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time to Maximum Concentration (Tmax) of MK-8521 for Type 2 Diabetes Mellitus (T2DM) and Non-Diabetic Overweight/Obese Participants in Part 2
Day 14
|
6 Hours
Interval 1.0 to 10.0
|
6 Hours
Interval 6.0 to 10.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time to Maximum Concentration (Tmax) of MK-8521 for Type 2 Diabetes Mellitus (T2DM) and Non-Diabetic Overweight/Obese Participants in Part 2
Day 19
|
6 Hours
Interval 6.0 to 10.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time to Maximum Concentration (Tmax) of MK-8521 for Type 2 Diabetes Mellitus (T2DM) and Non-Diabetic Overweight/Obese Participants in Part 2
Day 24
|
6 Hours
Interval 6.0 to 16.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose and 1, 2, 6, 10, 16, 24, 72, 96 and 120 hours post dose on Day 29Population: The analysis population included a subset of participants who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment according to the underlying scientific model and had data available for the analysis of the endpoint.
t1/2 was the time required to divide the MK-8521 concentration by half after reaching pseudo-equilibrium. Plasma samples were collected from predose to 120 hours postdose for determination of t1/2. Per protocol, t1/2 was measured on Day 29 which is the longest time point for sampling for T2DM participants 1/2 is presented as geometric mean and percent coefficient of variation of geometric mean.
Outcome measures
| Measure |
Part 1: MK-8521 64 μg/Day
n=16 Participants
Type 2 Diabetes Mellitus (T2DM) participants received once daily subcutaneous MK-8521 64 μg/day on Days 1 to 7 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 120 μg/Day
T2DM participants received once daily subcutaneous MK-8521 120 μg/day on Days 8 to 14 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 34 μg/Day
T2DM participants received once daily subcutaneous MK-8521 34 μg/day on Days 1 to 7 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: MK-8521 72 μg/Day
T2DM participants received once daily subcutaneous MK-8521 72 μg/day on Days 8 to 14 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: Liraglutide 0.6 mg/Day
T2DM participants received once daily subcutaneous liraglutide 0.6 mg on Day 1 and 2 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.2 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.2 mg on Days 3 to 7 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.8 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.8 mg on Days 8 to 14 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Placebo for MK-8521
T2DM participants received once daily subcutaneous placebo for MK-8521 for 14 days.
|
Part 2: Placebo for MK-8521-T2DM
T2DM participants received once daily subcutaneous placebo for MK-8521 for 29 days.
|
Part 2: MK-8521 64 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 64 µg/day on Days 1 to 7 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
Part 2: MK-8521 120 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 120 µg/day hon Days 8 to 14 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Terminal Half Life (t1/2) of MK-8521 on Day 29 for Type 2 Diabetes Mellitus (T2DM) Participants in Part 2
|
15.4 Hours
Geometric Coefficient of Variation 10.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose and 1, 2, 6, 10, 16, and 24 hours post dose on Day 14Population: The analysis population included a subset of participants who complied with the protocol sufficiently to ensure that their data exhibited the effects of treatment according to the underlying scientific model and had data available for the analysis of the endpoint.
t1/2 was the time required to divide the MK-8521 concentration by half after reaching pseudo-equilibrium. Plasma samples were collected from predose to 24 hours postdose for determination of t1/2. Per protocol, t1/2 was measured on Day 14 which is the longest time point for sampling for non-diabetic overweight/obese participants 1/2 is presented as geometric mean and percent coefficient of variation of geometric mean.
Outcome measures
| Measure |
Part 1: MK-8521 64 μg/Day
n=8 Participants
Type 2 Diabetes Mellitus (T2DM) participants received once daily subcutaneous MK-8521 64 μg/day on Days 1 to 7 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 120 μg/Day
T2DM participants received once daily subcutaneous MK-8521 120 μg/day on Days 8 to 14 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 34 μg/Day
T2DM participants received once daily subcutaneous MK-8521 34 μg/day on Days 1 to 7 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: MK-8521 72 μg/Day
T2DM participants received once daily subcutaneous MK-8521 72 μg/day on Days 8 to 14 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: Liraglutide 0.6 mg/Day
T2DM participants received once daily subcutaneous liraglutide 0.6 mg on Day 1 and 2 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.2 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.2 mg on Days 3 to 7 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.8 mg/Day
T2DM participants received once daily subcutaneous liraglutide 1.8 mg on Days 8 to 14 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Placebo for MK-8521
T2DM participants received once daily subcutaneous placebo for MK-8521 for 14 days.
|
Part 2: Placebo for MK-8521-T2DM
T2DM participants received once daily subcutaneous placebo for MK-8521 for 29 days.
|
Part 2: MK-8521 64 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 64 µg/day on Days 1 to 7 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
Part 2: MK-8521 120 µg/Day-Non-Diabetic Overweight/Obese
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 120 µg/day hon Days 8 to 14 as part of the MK-8521 64/120 µg/day treatment group schedule.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Terminal Half Life (t1/2) of MK-8521 on Day 14 for Non-Diabetic Overweight/Obese Participants in Part 2
|
14.4 Hours
Geometric Coefficient of Variation 10.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Part 1: MK-8521 64 μg/Day
Part 1: MK-8521 120 μg/Day
Part 1: MK-8521 34 μg/Day
Part 1: MK-8521 72 μg/Day
Part 1: Liraglutide 0.6 mg/Day
Part 1: Liraglutide 1.2 mg/Day
Part 1: Liraglutide 1.8 mg/Day
Part 1: Placebo for MK-8521
Part 2: MK-8521 64 μg/Day T2DM
Part 2: MK-8521 120 μg/Day T2DM
Part 2: MK-8521 180 μg/Day T2DM
Part 2: MK-8521 240 μg/Day T2DM
Part 2: MK-8521 300 μg/Day T2DM
Part 2: Liraglutide 0.6 mg/Day T2DM
Part 2: Liraglutide 1.2 mg/Day T2DM
Part 2: Liraglutide 1.8 mg/Day T2DM
Part 2: Placebo for MK-8521-T2DM
Part 2: MK-8521 64 μg/Day-Non-Diabetic Overweight/Obese
Part 2: MK-8521 120 μg/Day-Non-Diabetic Overweight/Obese
Serious adverse events
| Measure |
Part 1: MK-8521 64 μg/Day
n=9 participants at risk
Type 2 Diabetes Mellitus (T2DM) participants received once daily subcutaneous MK-8521 64 μg/day on Days 1 to 7 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 120 μg/Day
n=7 participants at risk
T2DM participants received once daily subcutaneous MK-8521 120 μg/day on Days 8 to 14 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 34 μg/Day
n=8 participants at risk
T2DM participants received once daily subcutaneous MK-8521 34 μg/day on Days 1 to 7 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: MK-8521 72 μg/Day
n=8 participants at risk
T2DM participants received once daily subcutaneous MK-8521 72 μg/day on Days 8 to 14 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: Liraglutide 0.6 mg/Day
n=11 participants at risk
T2DM participants received once daily subcutaneous liraglutide 0.6 mg on Day 1 and 2 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.2 mg/Day
n=11 participants at risk
T2DM participants received once daily subcutaneous liraglutide 1.2 mg on Days 3 to 7 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.8 mg/Day
n=8 participants at risk
T2DM participants received once daily subcutaneous liraglutide 1.8 mg on Days 8 to 14 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Placebo for MK-8521
n=8 participants at risk
T2DM participants received once daily subcutaneous placebo for MK-8521 for 14 days.
|
Part 2: MK-8521 64 μg/Day T2DM
n=18 participants at risk
Type 2 Diabetes Mellitus (T2DM) participants received once daily subcutaneous MK-8521 64 µg on Days 1 to 7 as part of the MK-8521 64/120/180/240/300 µg treatment sequence.
|
Part 2: MK-8521 120 μg/Day T2DM
n=18 participants at risk
T2DM participants received once daily subcutaneous MK-8521 120 µg on Days 8 to 14 as part of the MK-8521 64/120/180/240/300 µg treatment sequence.
|
Part 2: MK-8521 180 μg/Day T2DM
n=18 participants at risk
T2DM participants received once daily subcutaneous MK-8521 180 µg on Days 15 to 19 as part of the MK-8521 64/120/180/240/300 µg treatment sequence.
|
Part 2: MK-8521 240 μg/Day T2DM
n=18 participants at risk
T2DM participants received once daily subcutaneous MK-8521 240 µg on Days 20 to 24 as part of the MK-8521 64/120/180/240/300 µg treatment sequence.
|
Part 2: MK-8521 300 μg/Day T2DM
n=15 participants at risk
T2DM participants received once daily subcutaneous MK-8521 300 µg on Days 25 to 29 as part of the MK-8521 64/120/180/240/300 µg treatment sequence.
|
Part 2: Liraglutide 0.6 mg/Day T2DM
n=14 participants at risk
T2DM participants received once daily subcutaneous liraglutide 0.6 mg on Days 1 to 7 as part of the liraglutide 0.6/1.2/1.8 mg treatment sequence.
|
Part 2: Liraglutide 1.2 mg/Day T2DM
n=13 participants at risk
T2DM participants received once daily subcutaneous liraglutide 1.2 mg on Days 8 to 14 as part of the liraglutide 0.6/1.2/1.8 mg treatment sequence.
|
Part 2: Liraglutide 1.8 mg/Day T2DM
n=13 participants at risk
T2DM participants received once daily subcutaneous liraglutide 1.8 mg on Days 15 to 29 as part of the liraglutide 0.6/1.2/1.8 mg treatment sequence.
|
Part 2: Placebo for MK-8521-T2DM
n=6 participants at risk
T2DM participants received once daily subcutaneous placebo for MK-8521 for 29 days.
|
Part 2: MK-8521 64 μg/Day-Non-Diabetic Overweight/Obese
n=8 participants at risk
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 64 µg on Days 1 to 7 as part of the MK-8521 64/120 µg treatment sequence.
|
Part 2: MK-8521 120 μg/Day-Non-Diabetic Overweight/Obese
n=8 participants at risk
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 120 µg on Days 8 to 14 as part of the MK-8521 64/120 µg treatment sequence.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Sick sinus syndrome
|
11.1%
1/9 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
5.6%
1/18 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Nervous system disorders
Convulsion
|
11.1%
1/9 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
5.6%
1/18 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
Other adverse events
| Measure |
Part 1: MK-8521 64 μg/Day
n=9 participants at risk
Type 2 Diabetes Mellitus (T2DM) participants received once daily subcutaneous MK-8521 64 μg/day on Days 1 to 7 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 120 μg/Day
n=7 participants at risk
T2DM participants received once daily subcutaneous MK-8521 120 μg/day on Days 8 to 14 as part of the MK-8521 64/120 μg/day treatment group schedule.
|
Part 1: MK-8521 34 μg/Day
n=8 participants at risk
T2DM participants received once daily subcutaneous MK-8521 34 μg/day on Days 1 to 7 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: MK-8521 72 μg/Day
n=8 participants at risk
T2DM participants received once daily subcutaneous MK-8521 72 μg/day on Days 8 to 14 as part of the MK-8521 34/72 μg/day treatment group schedule.
|
Part 1: Liraglutide 0.6 mg/Day
n=11 participants at risk
T2DM participants received once daily subcutaneous liraglutide 0.6 mg on Day 1 and 2 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.2 mg/Day
n=11 participants at risk
T2DM participants received once daily subcutaneous liraglutide 1.2 mg on Days 3 to 7 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Liraglutide 1.8 mg/Day
n=8 participants at risk
T2DM participants received once daily subcutaneous liraglutide 1.8 mg on Days 8 to 14 as part of the liraglutide 0.6/1.2/1.8 mg/day treatment group schedule.
|
Part 1: Placebo for MK-8521
n=8 participants at risk
T2DM participants received once daily subcutaneous placebo for MK-8521 for 14 days.
|
Part 2: MK-8521 64 μg/Day T2DM
n=18 participants at risk
Type 2 Diabetes Mellitus (T2DM) participants received once daily subcutaneous MK-8521 64 µg on Days 1 to 7 as part of the MK-8521 64/120/180/240/300 µg treatment sequence.
|
Part 2: MK-8521 120 μg/Day T2DM
n=18 participants at risk
T2DM participants received once daily subcutaneous MK-8521 120 µg on Days 8 to 14 as part of the MK-8521 64/120/180/240/300 µg treatment sequence.
|
Part 2: MK-8521 180 μg/Day T2DM
n=18 participants at risk
T2DM participants received once daily subcutaneous MK-8521 180 µg on Days 15 to 19 as part of the MK-8521 64/120/180/240/300 µg treatment sequence.
|
Part 2: MK-8521 240 μg/Day T2DM
n=18 participants at risk
T2DM participants received once daily subcutaneous MK-8521 240 µg on Days 20 to 24 as part of the MK-8521 64/120/180/240/300 µg treatment sequence.
|
Part 2: MK-8521 300 μg/Day T2DM
n=15 participants at risk
T2DM participants received once daily subcutaneous MK-8521 300 µg on Days 25 to 29 as part of the MK-8521 64/120/180/240/300 µg treatment sequence.
|
Part 2: Liraglutide 0.6 mg/Day T2DM
n=14 participants at risk
T2DM participants received once daily subcutaneous liraglutide 0.6 mg on Days 1 to 7 as part of the liraglutide 0.6/1.2/1.8 mg treatment sequence.
|
Part 2: Liraglutide 1.2 mg/Day T2DM
n=13 participants at risk
T2DM participants received once daily subcutaneous liraglutide 1.2 mg on Days 8 to 14 as part of the liraglutide 0.6/1.2/1.8 mg treatment sequence.
|
Part 2: Liraglutide 1.8 mg/Day T2DM
n=13 participants at risk
T2DM participants received once daily subcutaneous liraglutide 1.8 mg on Days 15 to 29 as part of the liraglutide 0.6/1.2/1.8 mg treatment sequence.
|
Part 2: Placebo for MK-8521-T2DM
n=6 participants at risk
T2DM participants received once daily subcutaneous placebo for MK-8521 for 29 days.
|
Part 2: MK-8521 64 μg/Day-Non-Diabetic Overweight/Obese
n=8 participants at risk
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 64 µg on Days 1 to 7 as part of the MK-8521 64/120 µg treatment sequence.
|
Part 2: MK-8521 120 μg/Day-Non-Diabetic Overweight/Obese
n=8 participants at risk
Non-diabetic overweight/obese participants received once daily subcutaneous MK-8521 120 µg on Days 8 to 14 as part of the MK-8521 64/120 µg treatment sequence.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Tachycardia paroxysmal
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
5.6%
1/18 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
5.6%
1/18 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
7.7%
1/13 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
5.6%
1/18 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Cardiac disorders
Supraventricular tachycardia
|
11.1%
1/9 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
7.7%
1/13 • Number of events 2 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Cardiac disorders
Tachycardia
|
22.2%
2/9 • Number of events 2 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
14.3%
1/7 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
6.7%
1/15 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
7.7%
1/13 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
7.7%
1/13 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
5.6%
1/18 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
15.4%
2/13 • Number of events 2 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Eye disorders
Vision blurred
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
16.7%
1/6 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
7.7%
1/13 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
5.6%
1/18 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
5.6%
1/18 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
6.7%
1/15 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
9.1%
1/11 • Number of events 2 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
11.1%
2/18 • Number of events 2 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
11.1%
2/18 • Number of events 2 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
7.7%
1/13 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
15.4%
2/13 • Number of events 2 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
5.6%
1/18 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
5.6%
1/18 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
6.7%
1/15 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
7.1%
1/14 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
23.1%
3/13 • Number of events 4 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
12.5%
1/8 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
11.1%
1/9 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Gastrointestinal disorders
Change of bowel habit
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
7.1%
1/14 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
12.5%
1/8 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Gastrointestinal disorders
Constipation
|
11.1%
1/9 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
5.6%
1/18 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
22.2%
4/18 • Number of events 4 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
5.6%
1/18 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
7.1%
1/14 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
7.7%
1/13 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
15.4%
2/13 • Number of events 3 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Gastrointestinal disorders
Diarrhoea
|
11.1%
1/9 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
27.3%
3/11 • Number of events 3 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
22.2%
4/18 • Number of events 6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
33.3%
6/18 • Number of events 6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
5.6%
1/18 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
20.0%
3/15 • Number of events 3 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
35.7%
5/14 • Number of events 6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
30.8%
4/13 • Number of events 4 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
16.7%
1/6 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
12.5%
1/8 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
5.6%
1/18 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Gastrointestinal disorders
Dyspepsia
|
11.1%
1/9 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
27.3%
3/11 • Number of events 3 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
12.5%
1/8 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
5.6%
1/18 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
11.1%
2/18 • Number of events 2 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
5.6%
1/18 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
14.3%
1/7 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
5.6%
1/18 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
5.6%
1/18 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
7.1%
1/14 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Gastrointestinal disorders
Mouth ulceration
|
11.1%
1/9 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
14.3%
1/7 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
12.5%
1/8 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
9.1%
1/11 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
36.4%
4/11 • Number of events 4 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
11.1%
2/18 • Number of events 4 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
22.2%
4/18 • Number of events 4 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
27.8%
5/18 • Number of events 6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
6.7%
1/15 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
35.7%
5/14 • Number of events 7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
15.4%
2/13 • Number of events 3 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
38.5%
5/13 • Number of events 6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
16.7%
1/6 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
12.5%
1/8 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Gastrointestinal disorders
Regurgitation
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
7.7%
1/13 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
7.1%
1/14 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
7.7%
1/13 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
16.7%
1/6 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
9.1%
1/11 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
9.1%
1/11 • Number of events 3 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
5.6%
1/18 • Number of events 2 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
5.6%
1/18 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
6.7%
1/15 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
7.1%
1/14 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
15.4%
2/13 • Number of events 3 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
General disorders
Application site dermatitis
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
12.5%
1/8 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
5.6%
1/18 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
5.6%
1/18 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
7.1%
1/14 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
7.7%
1/13 • Number of events 2 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
General disorders
Application site erythema
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
6.7%
1/15 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
General disorders
Application site irritation
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
12.5%
1/8 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
7.7%
1/13 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
16.7%
1/6 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
12.5%
1/8 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
General disorders
Application site pruritus
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
5.6%
1/18 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
General disorders
Asthenia
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
9.1%
1/11 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
5.6%
1/18 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
5.6%
1/18 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
General disorders
Catheter site erythema
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
7.7%
1/13 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
General disorders
Catheter site haemorrhage
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
7.7%
1/13 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
7.7%
1/13 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
General disorders
Oedema peripheral
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
5.6%
1/18 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
General disorders
Catheter site oedema
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
7.7%
1/13 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
General disorders
Chest pain
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
9.1%
1/11 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
7.7%
1/13 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
General disorders
Early satiety
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
6.7%
1/15 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
General disorders
Feeling cold
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
7.7%
1/13 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
General disorders
Feeling hot
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
5.6%
1/18 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
General disorders
Influenza like illness
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
12.5%
1/8 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
5.6%
1/18 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
7.7%
1/13 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
General disorders
Injection site erythema
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
16.7%
1/6 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
14.3%
1/7 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
5.6%
1/18 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
5.6%
1/18 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
General disorders
Injection site injury
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
5.6%
1/18 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
General disorders
Injection site macule
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
5.6%
1/18 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
5.6%
1/18 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
General disorders
Peripheral swelling
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
5.6%
1/18 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
6.7%
1/15 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
General disorders
Pyrexia
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
12.5%
1/8 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
General disorders
Vessel puncture site erythema
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
12.5%
1/8 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
General disorders
Vessel puncture site haemorrhage
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
12.5%
1/8 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
5.6%
1/18 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
7.7%
1/13 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
12.5%
1/8 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
12.5%
1/8 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
General disorders
Xerosis
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
5.6%
1/18 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
7.7%
1/13 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Infections and infestations
Localised infection
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
6.7%
1/15 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
16.7%
1/6 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
6.7%
1/15 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Infections and infestations
Viral infection
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
5.6%
1/18 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
6.7%
1/15 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Infections and infestations
Viral pharyngitis
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
7.7%
1/13 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
14.3%
1/7 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
15.4%
2/13 • Number of events 3 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
12.5%
1/8 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Investigations
Lipase increased
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
12.5%
1/8 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
12.5%
1/8 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
22.2%
4/18 • Number of events 4 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
6.7%
1/15 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
7.7%
1/13 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Investigations
Weight decreased
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
7.7%
1/13 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
11.1%
2/18 • Number of events 2 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
5.6%
1/18 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
14.3%
2/14 • Number of events 2 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
7.7%
1/13 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
16.7%
1/6 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
12.5%
1/8 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
5.6%
1/18 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
16.7%
1/6 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
16.7%
1/6 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
7.7%
1/13 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
5.6%
1/18 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
11.1%
2/18 • Number of events 2 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
6.7%
1/15 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
5.6%
1/18 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
5.6%
1/18 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
5.6%
1/18 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
5.6%
1/18 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
7.7%
1/13 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
9.1%
1/11 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
5.6%
1/18 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
5.6%
1/18 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
5.6%
1/18 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
7.1%
1/14 • Number of events 2 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
7.7%
1/13 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
16.7%
1/6 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
16.7%
1/6 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Nervous system disorders
Headache
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
14.3%
1/7 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
12.5%
1/8 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
27.3%
3/11 • Number of events 4 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
12.5%
1/8 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
16.7%
3/18 • Number of events 3 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
22.2%
4/18 • Number of events 5 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
5.6%
1/18 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
6.7%
1/15 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
7.1%
1/14 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
7.7%
1/13 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
23.1%
3/13 • Number of events 4 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
16.7%
1/6 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
5.6%
1/18 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
5.6%
1/18 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
7.7%
1/13 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
16.7%
1/6 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Nervous system disorders
Tremor
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
5.6%
1/18 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
9.1%
1/11 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Psychiatric disorders
Dysthymic disorder
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
7.7%
1/13 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Psychiatric disorders
Insomnia
|
11.1%
1/9 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
6.7%
1/15 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
12.5%
1/8 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
7.7%
1/13 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
9.1%
1/11 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
5.6%
1/18 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
5.6%
1/18 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
7.1%
1/14 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
7.7%
1/13 • Number of events 2 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
5.6%
1/18 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
5.6%
1/18 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
5.6%
1/18 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
12.5%
1/8 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
5.6%
1/18 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
7.7%
1/13 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
12.5%
1/8 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
12.5%
1/8 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
12.5%
1/8 • Number of events 2 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
7.1%
1/14 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
7.7%
1/13 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
5.6%
1/18 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.1%
1/9 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
12.5%
1/8 • Number of events 2 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
18.2%
2/11 • Number of events 2 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
25.0%
2/8 • Number of events 2 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
5.6%
1/18 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
11.1%
2/18 • Number of events 2 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
6.7%
1/15 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
12.5%
1/8 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
12.5%
1/8 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
6.7%
1/15 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
6.7%
1/15 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
12.5%
1/8 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
12.5%
1/8 • Number of events 2 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
5.6%
1/18 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
12.5%
1/8 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
14.3%
1/7 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
16.7%
1/6 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Skin and subcutaneous tissue disorders
Skin wrinkling
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
7.7%
1/13 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Vascular disorders
Flushing
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
5.6%
1/18 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
7.7%
1/13 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
|
Vascular disorders
Hypotension
|
0.00%
0/9 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/7 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/11 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/18 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/15 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/14 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
7.7%
1/13 • Number of events 1 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/13 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/6 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
0.00%
0/8 • Up to approximately 42 days for Part 1 and up to approximately 57 days for Part 2
All participants that received ≥1 dose of study drug for adverse events (AEs) and all randomized participants for all-cause mortality. AEs and all-cause mortality are presented by individual dose received by participants during titration in an assigned study treatment sequence.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
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 trial 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