Trial Outcomes & Findings for Single and Multiple Ascending Dose Study of AMG 171 in Subjects With Obesity (NCT NCT04199351)
NCT ID: NCT04199351
Last Updated: 2024-09-19
Results Overview
An adverse event (AE) was any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with study treatment. A serious AE (SAE) was an AE meeting at least 1 of the following serious criteria: fatal, life-threatening, required in-patient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability; congenital anomaly/birth defect; other medically important serious event. Clinically significant changes from baseline in laboratory safety tests, vital sign assessments, and 12-lead electrocardiogram assessments were included as TEAEs.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
60 participants
Primary outcome timeframe
From first dose of IP to end of study, up to Day 207
Results posted on
2024-09-19
Participant Flow
Participants were enrolled at 3 study centers in the United States, and participated from 13 December 2019 to 10 September 2021.
Participants were enrolled into single ascending dose (SAD) cohorts in Part A (Cohorts 1 and 1b), a multiple dosing cohort in Part B (Cohort 2), and step dosing cohorts in Part C (Cohorts 3 - 5). Three doses were given: Dose A (low dose), Dose B (intermediate dose), and Dose C (high dose).
Participant milestones
| Measure |
Placebo (Cohorts 1 and 1b)
Participants in Part A Cohorts 1 and 1b were randomized to receive a single subcutaneous (SC) dose of placebo on Day 1.
|
Cohort 1 (Part A): AMG 171 Dose A
Participants were randomized to receive AMG 171 Dose A as a single SC dose on Day 1.
|
Cohort 1b (Part A): AMG 171 Dose B
Participants were randomized to receive AMG 171 Dose B as a single SC dose on Day 1.
|
Placebo (Cohort 4 Replaced)
Participants enrolled in Part C Cohort 4 received compromised or expired investigational product (IP). These participants were randomized to receive placebo on Day 1, Day 15, and on Day 29, as SC doses.
|
Placebo (Cohorts 2-5)
Participants in Parts B and C (Cohorts 2-5) were randomized to receive multiple SC doses of placebo.
|
Cohort 2 (Part B): AMG 171 Dose A Q2W
Participants were randomized to receive AMG 171 Dose A every 2 weeks (Q2W) on Days 1, 15, 29, 43, 57, and 71, as SC doses.
|
Cohort 3 (Part C): AMG 171 Dose A/Dose B
Participants were randomized to receive AMG 171 Dose A on Day 1 and Dose B on Day 15, as SC doses.
|
Cohort 4 (Part C): AMG 171 Dose A/Dose B/Dose C
Participants were randomized to receive AMG 171 Dose A on Day 1, Dose B on Day 15, and Dose C on Day 29, as SC doses.
|
Cohort 5 (Part C): AMG 171 Dose A/Dose B
Participants were randomized to receive AMG 171 Dose A on Day 1 and Dose B on Day 8, as SC doses.
|
Cohort 4 Replaced (Part C): AMG 171 Dose A/Dose B/Dose C
Participants enrolled in Part C Cohort 4 received compromised or expired IP. These participants were randomized to receive AMG 171 Dose A on Day 1, Dose B on Day 15, and Dose C on Day 29, as SC doses.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
7
|
6
|
2
|
8
|
7
|
8
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
4
|
6
|
5
|
0
|
7
|
2
|
6
|
6
|
3
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
2
|
1
|
5
|
2
|
0
|
3
|
6
|
Reasons for withdrawal
| Measure |
Placebo (Cohorts 1 and 1b)
Participants in Part A Cohorts 1 and 1b were randomized to receive a single subcutaneous (SC) dose of placebo on Day 1.
|
Cohort 1 (Part A): AMG 171 Dose A
Participants were randomized to receive AMG 171 Dose A as a single SC dose on Day 1.
|
Cohort 1b (Part A): AMG 171 Dose B
Participants were randomized to receive AMG 171 Dose B as a single SC dose on Day 1.
|
Placebo (Cohort 4 Replaced)
Participants enrolled in Part C Cohort 4 received compromised or expired investigational product (IP). These participants were randomized to receive placebo on Day 1, Day 15, and on Day 29, as SC doses.
|
Placebo (Cohorts 2-5)
Participants in Parts B and C (Cohorts 2-5) were randomized to receive multiple SC doses of placebo.
|
Cohort 2 (Part B): AMG 171 Dose A Q2W
Participants were randomized to receive AMG 171 Dose A every 2 weeks (Q2W) on Days 1, 15, 29, 43, 57, and 71, as SC doses.
|
Cohort 3 (Part C): AMG 171 Dose A/Dose B
Participants were randomized to receive AMG 171 Dose A on Day 1 and Dose B on Day 15, as SC doses.
|
Cohort 4 (Part C): AMG 171 Dose A/Dose B/Dose C
Participants were randomized to receive AMG 171 Dose A on Day 1, Dose B on Day 15, and Dose C on Day 29, as SC doses.
|
Cohort 5 (Part C): AMG 171 Dose A/Dose B
Participants were randomized to receive AMG 171 Dose A on Day 1 and Dose B on Day 8, as SC doses.
|
Cohort 4 Replaced (Part C): AMG 171 Dose A/Dose B/Dose C
Participants enrolled in Part C Cohort 4 received compromised or expired IP. These participants were randomized to receive AMG 171 Dose A on Day 1, Dose B on Day 15, and Dose C on Day 29, as SC doses.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Decision by sponsor
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
6
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
1
|
4
|
2
|
0
|
3
|
0
|
Baseline Characteristics
Single and Multiple Ascending Dose Study of AMG 171 in Subjects With Obesity
Baseline characteristics by cohort
| Measure |
Placebo (Cohort 1 and 1b)
n=4 Participants
Participants in Part A Cohorts 1 and 1b were randomized to receive a single SC dose of placebo on Day 1.
|
Cohort 1 (Part A): AMG 171 Dose A
n=7 Participants
Participants were randomized to receive AMG 171 Dose A as a single SC dose on Day 1.
|
Cohort 1b (Part A): AMG 171 Dose B
n=6 Participants
Participants were randomized to receive AMG 171 Dose B as a single SC dose on Day 1.
|
Placebo (Cohort 4 Replaced)
n=2 Participants
Participants enrolled in Part C Cohort 4 received compromised or expired IP. These participants were randomized to receive placebo on Day 1, Day 15, and on Day 29, as SC doses.
|
Placebo (Cohorts 2-5)
n=8 Participants
Participants in Parts B and C (Cohorts 2-5) were randomized to receive multiple SC doses of placebo.
|
Cohort 2 (Part B): AMG 171 Dose A Q2W
n=7 Participants
Participants were randomized to receive AMG 171 Dose A Q2W on Days 1, 15, 29, 43, 57, and 71, as SC doses.
|
Cohort 3 (Part C): AMG 171 Dose A/Dose B
n=8 Participants
Participants were randomized to receive AMG 171 Dose A on Day 1 and Dose B on Day 15, as SC doses.
|
Cohort 4 (Part C): AMG 171 Dose A/Dose B/Dose C
n=6 Participants
Participants were randomized to receive AMG 171 Dose A on Day 1, Dose B on Day 15, and Dose C on Day 29, as SC doses.
|
Cohort 5 (Part C): AMG 171 Dose A/Dose B
n=6 Participants
Participants were randomized to receive AMG 171 Dose A on Day 1 and Dose B on Day 8, as SC doses.
|
Cohort 4 Replaced (Part C): AMG 171 Dose A/Dose B/Dose C
n=6 Participants
Participants enrolled in Part C Cohort 4 received compromised or expired IP. These participants were randomized to receive AMG 171 Dose A on Day 1, Dose B on Day 15, and Dose C on Day 29, as SC doses.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
6 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
5 Participants
n=114 Participants
|
0 Participants
|
26 Participants
n=19 Participants
|
|
Age, Customized
< 18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
|
Age, Customized
18 - 64 years
|
4 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
7 Participants
n=30 Participants
|
8 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=114 Participants
|
6 Participants
|
60 Participants
n=19 Participants
|
|
Age, Customized
≥ 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
3 Participants
n=114 Participants
|
2 Participants
|
16 Participants
n=19 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
5 Participants
n=30 Participants
|
6 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
3 Participants
n=114 Participants
|
4 Participants
|
44 Participants
n=19 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
6 Participants
|
34 Participants
n=19 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
1 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
4 Participants
n=114 Participants
|
3 Participants
|
21 Participants
n=19 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
5 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
3 Participants
|
38 Participants
n=19 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
PRIMARY outcome
Timeframe: From first dose of IP to end of study, up to Day 207Population: The safety analysis set included all participants who received at least 1 dose of IP.
An adverse event (AE) was any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with study treatment. A serious AE (SAE) was an AE meeting at least 1 of the following serious criteria: fatal, life-threatening, required in-patient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability; congenital anomaly/birth defect; other medically important serious event. Clinically significant changes from baseline in laboratory safety tests, vital sign assessments, and 12-lead electrocardiogram assessments were included as TEAEs.
Outcome measures
| Measure |
Placebo (Cohort 1 and 1b)
n=4 Participants
Participants in Part A Cohorts 1 and 1b were randomized to receive a single SC dose of placebo on Day 1.
|
Cohort 1 (Part A): AMG 171 Dose A
n=7 Participants
Participants were randomized to receive AMG 171 Dose A as a single SC dose on Day 1.
|
Cohort 1b (Part A): AMG 171 Dose B
n=6 Participants
Participants were randomized to receive AMG 171 Dose B as a single SC dose on Day 1.
|
Placebo (Cohort 4 Replaced)
n=2 Participants
Participants enrolled in Part C Cohort 4 received compromised or expired IP. These participants were randomized to receive placebo on Day 1, Day 15, and on Day 29, as SC doses.
|
Placebo (Cohorts 2-5)
n=8 Participants
Participants in Parts B and C (Cohorts 2-5) were randomized to receive multiple SC doses of placebo.
|
Cohort 2 (Part B): AMG 171 Dose A Q2W
n=7 Participants
Participants were randomized to receive AMG 171 Dose A Q2W on Days 1, 15, 29, 43, 57, and 71, as SC doses.
|
Cohort 3 (Part C): AMG 171 Dose A/Dose B
n=8 Participants
Participants were randomized to receive AMG 171 Dose A on Day 1 and Dose B on Day 15, as SC doses.
|
Cohort 4 (Part C): AMG 171 Dose A/Dose B/Dose C
n=6 Participants
Participants were randomized to receive AMG 171 Dose A on Day 1, Dose B on Day 15, and Dose C on Day 29, as SC doses.
|
Cohort 5 (Part C): AMG 171 Dose A/Dose B
n=6 Participants
Participants were randomized to receive AMG 171 Dose A on Day 1 and Dose B on Day 8, as SC doses.
|
Cohort 4 Replaced (Part C): AMG 171 Dose A/Dose B/Dose C
n=6 Participants
Participants enrolled in Part C Cohort 4 received compromised or expired IP. These participants were randomized to receive AMG 171 Dose A on Day 1, Dose B on Day 15, and Dose C on Day 29, as SC doses.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs)
Any TEAEs
|
0 Participants
|
5 Participants
|
6 Participants
|
0 Participants
|
3 Participants
|
7 Participants
|
5 Participants
|
5 Participants
|
5 Participants
|
5 Participants
|
|
Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs)
Any SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs)
Any TEAE leading to IP discontinuation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Cohorts 1 and 1b: pre-dose Day 1; 1, 2, 4, and 8 hours post-dose Day 1, Days 2 up to Day 120Population: The PK analysis set included all participants who received at least 1 dose of AMG 171 for whom at least 1 PK parameter could be adequately estimated.
Serum concentrations of AMG 171 were determined using a validated assay. Noncompartmental analysis was performed for estimation of pharmacokinetic (PK) parameters. Concentrations below the lower limit of quantification (LLOQ) (50.0 ng/mL) were set to zero before data analysis.
Outcome measures
| Measure |
Placebo (Cohort 1 and 1b)
n=7 Participants
Participants in Part A Cohorts 1 and 1b were randomized to receive a single SC dose of placebo on Day 1.
|
Cohort 1 (Part A): AMG 171 Dose A
n=6 Participants
Participants were randomized to receive AMG 171 Dose A as a single SC dose on Day 1.
|
Cohort 1b (Part A): AMG 171 Dose B
Participants were randomized to receive AMG 171 Dose B as a single SC dose on Day 1.
|
Placebo (Cohort 4 Replaced)
Participants enrolled in Part C Cohort 4 received compromised or expired IP. These participants were randomized to receive placebo on Day 1, Day 15, and on Day 29, as SC doses.
|
Placebo (Cohorts 2-5)
Participants in Parts B and C (Cohorts 2-5) were randomized to receive multiple SC doses of placebo.
|
Cohort 2 (Part B): AMG 171 Dose A Q2W
Participants were randomized to receive AMG 171 Dose A Q2W on Days 1, 15, 29, 43, 57, and 71, as SC doses.
|
Cohort 3 (Part C): AMG 171 Dose A/Dose B
Participants were randomized to receive AMG 171 Dose A on Day 1 and Dose B on Day 15, as SC doses.
|
Cohort 4 (Part C): AMG 171 Dose A/Dose B/Dose C
Participants were randomized to receive AMG 171 Dose A on Day 1, Dose B on Day 15, and Dose C on Day 29, as SC doses.
|
Cohort 5 (Part C): AMG 171 Dose A/Dose B
Participants were randomized to receive AMG 171 Dose A on Day 1 and Dose B on Day 8, as SC doses.
|
Cohort 4 Replaced (Part C): AMG 171 Dose A/Dose B/Dose C
Participants enrolled in Part C Cohort 4 received compromised or expired IP. These participants were randomized to receive AMG 171 Dose A on Day 1, Dose B on Day 15, and Dose C on Day 29, as SC doses.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Serum Concentration (Cmax) for AMG 171: SAD Cohorts 1 and 1b
|
697 ng/mL
Standard Deviation 405
|
1740 ng/mL
Standard Deviation 759
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohort 2: pre-dose Days 1, 15, 29, 43, 57, 71; post-dose Days 5 up to 207; Cohort 3: pre-dose Days 1, 15; post-dose Days 2 up to 85; Cohort 4: pre-dose Days 1, 15, 29; post-dose Days 2 up to 113; Cohort 5: pre-dose Days 1, 8; post-dose Days 2 up to 85Population: The PK analysis set included all participants who received at least 1 dose of AMG 171 for whom at least 1 PK parameter could be adequately estimated.
Serum concentrations of AMG 171 were determined using a validated assay. Noncompartmental analysis was performed for estimation of PK parameters. Concentrations below the LLOQ (50.0 ng/mL) were set to zero before data analysis.
Outcome measures
| Measure |
Placebo (Cohort 1 and 1b)
n=7 Participants
Participants in Part A Cohorts 1 and 1b were randomized to receive a single SC dose of placebo on Day 1.
|
Cohort 1 (Part A): AMG 171 Dose A
n=8 Participants
Participants were randomized to receive AMG 171 Dose A as a single SC dose on Day 1.
|
Cohort 1b (Part A): AMG 171 Dose B
n=6 Participants
Participants were randomized to receive AMG 171 Dose B as a single SC dose on Day 1.
|
Placebo (Cohort 4 Replaced)
n=6 Participants
Participants enrolled in Part C Cohort 4 received compromised or expired IP. These participants were randomized to receive placebo on Day 1, Day 15, and on Day 29, as SC doses.
|
Placebo (Cohorts 2-5)
Participants in Parts B and C (Cohorts 2-5) were randomized to receive multiple SC doses of placebo.
|
Cohort 2 (Part B): AMG 171 Dose A Q2W
Participants were randomized to receive AMG 171 Dose A Q2W on Days 1, 15, 29, 43, 57, and 71, as SC doses.
|
Cohort 3 (Part C): AMG 171 Dose A/Dose B
Participants were randomized to receive AMG 171 Dose A on Day 1 and Dose B on Day 15, as SC doses.
|
Cohort 4 (Part C): AMG 171 Dose A/Dose B/Dose C
Participants were randomized to receive AMG 171 Dose A on Day 1, Dose B on Day 15, and Dose C on Day 29, as SC doses.
|
Cohort 5 (Part C): AMG 171 Dose A/Dose B
Participants were randomized to receive AMG 171 Dose A on Day 1 and Dose B on Day 8, as SC doses.
|
Cohort 4 Replaced (Part C): AMG 171 Dose A/Dose B/Dose C
Participants enrolled in Part C Cohort 4 received compromised or expired IP. These participants were randomized to receive AMG 171 Dose A on Day 1, Dose B on Day 15, and Dose C on Day 29, as SC doses.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax for AMG 171: MAD Cohorts 2 - 5
Day 1
|
695 ng/mL
Standard Deviation 229
|
847 ng/mL
Standard Deviation 522
|
455 ng/mL
Standard Deviation 335
|
769 ng/mL
Standard Deviation 470
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cmax for AMG 171: MAD Cohorts 2 - 5
Day 8
|
—
|
—
|
—
|
2550 ng/mL
Standard Deviation 1820
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cmax for AMG 171: MAD Cohorts 2 - 5
Day 15
|
—
|
1350 ng/mL
Standard Deviation 670
|
1760 ng/mL
Standard Deviation 1080
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cmax for AMG 171: MAD Cohorts 2 - 5
Day 29
|
—
|
—
|
3960 ng/mL
Standard Deviation 1600
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cmax for AMG 171: MAD Cohorts 2 - 5
Day 71
|
1490 ng/mL
Standard Deviation 702
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohorts 1 and 1b: pre-dose Day 1; 1, 2, 4, and 8 hours post-dose Day 1, Days 2 up to Day 120Population: The PK analysis set included all participants who received at least 1 dose of AMG 171 for whom at least 1 PK parameter could be adequately estimated.
Serum concentrations of AMG 171 were determined using a validated assay. Noncompartmental analysis was performed for estimation of PK parameters. Concentrations below the LLOQ (50.0 ng/mL) were set to zero before data analysis.
Outcome measures
| Measure |
Placebo (Cohort 1 and 1b)
n=7 Participants
Participants in Part A Cohorts 1 and 1b were randomized to receive a single SC dose of placebo on Day 1.
|
Cohort 1 (Part A): AMG 171 Dose A
n=6 Participants
Participants were randomized to receive AMG 171 Dose A as a single SC dose on Day 1.
|
Cohort 1b (Part A): AMG 171 Dose B
Participants were randomized to receive AMG 171 Dose B as a single SC dose on Day 1.
|
Placebo (Cohort 4 Replaced)
Participants enrolled in Part C Cohort 4 received compromised or expired IP. These participants were randomized to receive placebo on Day 1, Day 15, and on Day 29, as SC doses.
|
Placebo (Cohorts 2-5)
Participants in Parts B and C (Cohorts 2-5) were randomized to receive multiple SC doses of placebo.
|
Cohort 2 (Part B): AMG 171 Dose A Q2W
Participants were randomized to receive AMG 171 Dose A Q2W on Days 1, 15, 29, 43, 57, and 71, as SC doses.
|
Cohort 3 (Part C): AMG 171 Dose A/Dose B
Participants were randomized to receive AMG 171 Dose A on Day 1 and Dose B on Day 15, as SC doses.
|
Cohort 4 (Part C): AMG 171 Dose A/Dose B/Dose C
Participants were randomized to receive AMG 171 Dose A on Day 1, Dose B on Day 15, and Dose C on Day 29, as SC doses.
|
Cohort 5 (Part C): AMG 171 Dose A/Dose B
Participants were randomized to receive AMG 171 Dose A on Day 1 and Dose B on Day 8, as SC doses.
|
Cohort 4 Replaced (Part C): AMG 171 Dose A/Dose B/Dose C
Participants enrolled in Part C Cohort 4 received compromised or expired IP. These participants were randomized to receive AMG 171 Dose A on Day 1, Dose B on Day 15, and Dose C on Day 29, as SC doses.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Time of Cmax (Tmax) for AMG 171: SAD Cohorts 1 and 1b
|
120 hours
Interval 47.0 to 120.0
|
120 hours
Interval 72.0 to 120.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohort 2: pre-dose Days 1, 15, 29, 43, 57, 71; post-dose Days 5 up to 207; Cohort 3: pre-dose Days 1, 15; post-dose Days 2 up to 85; Cohort 4: pre-dose Days 1, 15, 29; post-dose Days 2 up to 113; Cohort 5: pre-dose Days 1, 8; post-dose Days 2 up to 85Population: The PK analysis set included all participants who received at least 1 dose of AMG 171 for whom at least 1 PK parameter could be adequately estimated.
Serum concentrations of AMG 171 were determined using a validated assay. Noncompartmental analysis was performed for estimation of PK parameters. Concentrations below the LLOQ (50.0 ng/mL) were set to zero before data analysis.
Outcome measures
| Measure |
Placebo (Cohort 1 and 1b)
n=7 Participants
Participants in Part A Cohorts 1 and 1b were randomized to receive a single SC dose of placebo on Day 1.
|
Cohort 1 (Part A): AMG 171 Dose A
n=8 Participants
Participants were randomized to receive AMG 171 Dose A as a single SC dose on Day 1.
|
Cohort 1b (Part A): AMG 171 Dose B
n=6 Participants
Participants were randomized to receive AMG 171 Dose B as a single SC dose on Day 1.
|
Placebo (Cohort 4 Replaced)
n=6 Participants
Participants enrolled in Part C Cohort 4 received compromised or expired IP. These participants were randomized to receive placebo on Day 1, Day 15, and on Day 29, as SC doses.
|
Placebo (Cohorts 2-5)
Participants in Parts B and C (Cohorts 2-5) were randomized to receive multiple SC doses of placebo.
|
Cohort 2 (Part B): AMG 171 Dose A Q2W
Participants were randomized to receive AMG 171 Dose A Q2W on Days 1, 15, 29, 43, 57, and 71, as SC doses.
|
Cohort 3 (Part C): AMG 171 Dose A/Dose B
Participants were randomized to receive AMG 171 Dose A on Day 1 and Dose B on Day 15, as SC doses.
|
Cohort 4 (Part C): AMG 171 Dose A/Dose B/Dose C
Participants were randomized to receive AMG 171 Dose A on Day 1, Dose B on Day 15, and Dose C on Day 29, as SC doses.
|
Cohort 5 (Part C): AMG 171 Dose A/Dose B
Participants were randomized to receive AMG 171 Dose A on Day 1 and Dose B on Day 8, as SC doses.
|
Cohort 4 Replaced (Part C): AMG 171 Dose A/Dose B/Dose C
Participants enrolled in Part C Cohort 4 received compromised or expired IP. These participants were randomized to receive AMG 171 Dose A on Day 1, Dose B on Day 15, and Dose C on Day 29, as SC doses.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Tmax for AMG 171: MAD Cohorts 2 - 5
Day 1
|
93 hours
Interval 91.0 to 310.0
|
60 hours
Interval 19.0 to 310.0
|
84 hours
Interval 48.0 to 190.0
|
58 hours
Interval 21.0 to 160.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Tmax for AMG 171: MAD Cohorts 2 - 5
Day 8
|
—
|
—
|
—
|
82 hours
Interval 45.0 to 220.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Tmax for AMG 171: MAD Cohorts 2 - 5
Day 15
|
—
|
72 hours
Interval 48.0 to 310.0
|
96 hours
Interval 48.0 to 120.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Tmax for AMG 171: MAD Cohorts 2 - 5
Day 29
|
—
|
—
|
110 hours
Interval 72.0 to 120.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Tmax for AMG 171: MAD Cohorts 2 - 5
Day 71
|
72 hours
Interval 61.0 to 73.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohorts 1 and 1b: pre-dose Day 1; 1, 2, 4, and 8 hours post-dose Day 1, Days 2 up to Day 120Population: The PK analysis set included all participants who received at least 1 dose of AMG 171 for whom at least 1 PK parameter could be adequately estimated. Participants with available data are included.
Serum concentrations of AMG 171 were determined using a validated assay. Noncompartmental analysis was performed for estimation of PK parameters. Concentrations below the LLOQ (50.0 ng/mL) were set to zero before data analysis.
Outcome measures
| Measure |
Placebo (Cohort 1 and 1b)
n=6 Participants
Participants in Part A Cohorts 1 and 1b were randomized to receive a single SC dose of placebo on Day 1.
|
Cohort 1 (Part A): AMG 171 Dose A
n=5 Participants
Participants were randomized to receive AMG 171 Dose A as a single SC dose on Day 1.
|
Cohort 1b (Part A): AMG 171 Dose B
Participants were randomized to receive AMG 171 Dose B as a single SC dose on Day 1.
|
Placebo (Cohort 4 Replaced)
Participants enrolled in Part C Cohort 4 received compromised or expired IP. These participants were randomized to receive placebo on Day 1, Day 15, and on Day 29, as SC doses.
|
Placebo (Cohorts 2-5)
Participants in Parts B and C (Cohorts 2-5) were randomized to receive multiple SC doses of placebo.
|
Cohort 2 (Part B): AMG 171 Dose A Q2W
Participants were randomized to receive AMG 171 Dose A Q2W on Days 1, 15, 29, 43, 57, and 71, as SC doses.
|
Cohort 3 (Part C): AMG 171 Dose A/Dose B
Participants were randomized to receive AMG 171 Dose A on Day 1 and Dose B on Day 15, as SC doses.
|
Cohort 4 (Part C): AMG 171 Dose A/Dose B/Dose C
Participants were randomized to receive AMG 171 Dose A on Day 1, Dose B on Day 15, and Dose C on Day 29, as SC doses.
|
Cohort 5 (Part C): AMG 171 Dose A/Dose B
Participants were randomized to receive AMG 171 Dose A on Day 1 and Dose B on Day 8, as SC doses.
|
Cohort 4 Replaced (Part C): AMG 171 Dose A/Dose B/Dose C
Participants enrolled in Part C Cohort 4 received compromised or expired IP. These participants were randomized to receive AMG 171 Dose A on Day 1, Dose B on Day 15, and Dose C on Day 29, as SC doses.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve (AUC) From Time 0 to Infinity (AUCinf) for AMG 171: SAD Cohorts 1 and 1b
|
285000 hours*ng/mL
Standard Deviation 72200
|
792000 hours*ng/mL
Standard Deviation 324000
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohort 2: pre-dose Days 1, 15, 29, 43, 57, 71; post-dose Days 5 up to 207; Cohort 3: pre-dose Days 1, 15; post-dose Days 2 up to 85; Cohort 4: pre-dose Days 1, 15, 29; post-dose Days 2 up to 113Population: The PK analysis set included all participants who received at least 1 dose of AMG 171 for whom at least 1 PK parameter could be adequately estimated. Participants with data available are included.
Serum concentrations of AMG 171 were determined using a validated assay. Noncompartmental analysis was performed for estimation of PK parameters. Concentrations below the LLOQ (50.0 ng/mL) were set to zero before data analysis.
Outcome measures
| Measure |
Placebo (Cohort 1 and 1b)
n=3 Participants
Participants in Part A Cohorts 1 and 1b were randomized to receive a single SC dose of placebo on Day 1.
|
Cohort 1 (Part A): AMG 171 Dose A
n=7 Participants
Participants were randomized to receive AMG 171 Dose A as a single SC dose on Day 1.
|
Cohort 1b (Part A): AMG 171 Dose B
n=6 Participants
Participants were randomized to receive AMG 171 Dose B as a single SC dose on Day 1.
|
Placebo (Cohort 4 Replaced)
Participants enrolled in Part C Cohort 4 received compromised or expired IP. These participants were randomized to receive placebo on Day 1, Day 15, and on Day 29, as SC doses.
|
Placebo (Cohorts 2-5)
Participants in Parts B and C (Cohorts 2-5) were randomized to receive multiple SC doses of placebo.
|
Cohort 2 (Part B): AMG 171 Dose A Q2W
Participants were randomized to receive AMG 171 Dose A Q2W on Days 1, 15, 29, 43, 57, and 71, as SC doses.
|
Cohort 3 (Part C): AMG 171 Dose A/Dose B
Participants were randomized to receive AMG 171 Dose A on Day 1 and Dose B on Day 15, as SC doses.
|
Cohort 4 (Part C): AMG 171 Dose A/Dose B/Dose C
Participants were randomized to receive AMG 171 Dose A on Day 1, Dose B on Day 15, and Dose C on Day 29, as SC doses.
|
Cohort 5 (Part C): AMG 171 Dose A/Dose B
Participants were randomized to receive AMG 171 Dose A on Day 1 and Dose B on Day 8, as SC doses.
|
Cohort 4 Replaced (Part C): AMG 171 Dose A/Dose B/Dose C
Participants enrolled in Part C Cohort 4 received compromised or expired IP. These participants were randomized to receive AMG 171 Dose A on Day 1, Dose B on Day 15, and Dose C on Day 29, as SC doses.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
AUC From Time 0 to 14 Days (AUC0-14) for AMG 171: MAD Cohorts 2 - 4
Day 71
|
375000 hours*ng/mL
Standard Deviation 120000
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
AUC From Time 0 to 14 Days (AUC0-14) for AMG 171: MAD Cohorts 2 - 4
Day 1
|
201000 hours*ng/mL
Standard Deviation 36400
|
205000 hours*ng/mL
Standard Deviation 123000
|
133000 hours*ng/mL
Standard Deviation 74000
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
AUC From Time 0 to 14 Days (AUC0-14) for AMG 171: MAD Cohorts 2 - 4
Day 15
|
—
|
362000 hours*ng/mL
Standard Deviation 160000
|
440000 hours*ng/mL
Standard Deviation 261000
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
AUC From Time 0 to 14 Days (AUC0-14) for AMG 171: MAD Cohorts 2 - 4
Day 29
|
—
|
—
|
1050000 hours*ng/mL
Standard Deviation 429000
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohort 5: pre-dose Days 1, 8; post-dose Days 2 up to 85Population: The PK analysis set included all participants who received at least 1 dose of AMG 171 for whom at least 1 PK parameter could be adequately estimated. Participants with data available are included.
Serum concentrations of AMG 171 were determined using a validated assay. Noncompartmental analysis was performed for estimation of PK parameters. Concentrations below the LLOQ (50.0 ng/mL) were set to zero before data analysis.
Outcome measures
| Measure |
Placebo (Cohort 1 and 1b)
n=4 Participants
Participants in Part A Cohorts 1 and 1b were randomized to receive a single SC dose of placebo on Day 1.
|
Cohort 1 (Part A): AMG 171 Dose A
Participants were randomized to receive AMG 171 Dose A as a single SC dose on Day 1.
|
Cohort 1b (Part A): AMG 171 Dose B
Participants were randomized to receive AMG 171 Dose B as a single SC dose on Day 1.
|
Placebo (Cohort 4 Replaced)
Participants enrolled in Part C Cohort 4 received compromised or expired IP. These participants were randomized to receive placebo on Day 1, Day 15, and on Day 29, as SC doses.
|
Placebo (Cohorts 2-5)
Participants in Parts B and C (Cohorts 2-5) were randomized to receive multiple SC doses of placebo.
|
Cohort 2 (Part B): AMG 171 Dose A Q2W
Participants were randomized to receive AMG 171 Dose A Q2W on Days 1, 15, 29, 43, 57, and 71, as SC doses.
|
Cohort 3 (Part C): AMG 171 Dose A/Dose B
Participants were randomized to receive AMG 171 Dose A on Day 1 and Dose B on Day 15, as SC doses.
|
Cohort 4 (Part C): AMG 171 Dose A/Dose B/Dose C
Participants were randomized to receive AMG 171 Dose A on Day 1, Dose B on Day 15, and Dose C on Day 29, as SC doses.
|
Cohort 5 (Part C): AMG 171 Dose A/Dose B
Participants were randomized to receive AMG 171 Dose A on Day 1 and Dose B on Day 8, as SC doses.
|
Cohort 4 Replaced (Part C): AMG 171 Dose A/Dose B/Dose C
Participants enrolled in Part C Cohort 4 received compromised or expired IP. These participants were randomized to receive AMG 171 Dose A on Day 1, Dose B on Day 15, and Dose C on Day 29, as SC doses.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
AUC From Time 0 to 7 Days (AUC0-7) for AMG 171: MAD Cohort 5
Day 1
|
138000 hours*ng/mL
Standard Deviation 47200
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
AUC From Time 0 to 7 Days (AUC0-7) for AMG 171: MAD Cohort 5
Day 8
|
351000 hours*ng/mL
Standard Deviation 272000
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohorts 1 and 1b: Day 1 pre-dose, Days 15, 29, 120; Cohort 2: Days 1, 29, 57 pre-dose, Days 15, 85, 207; Cohort 3: Days 1, 15 pre-dose, Days 29, 57, 85; Cohort 4: Days 1, 15, 29 pre-dose, Days 43, 85, 113; Cohort 5: Days 1, 8 pre-dose, Days 29, 57, 85Population: The safety analysis set included all participants who received at least 1 dose of IP. Data for participants with an on-study result are included.
Serum samples were tested for binding and neutralizing antibodies against human Growth Differentiation Factor 15. Participants with transiently positive for binding or neutralizing antibodies had a negative result at the participant's last time point tested. bAb = binding antibody; nAb = neutralizing antibody; +ve = positive; -ve = negative; BL = baseline.
Outcome measures
| Measure |
Placebo (Cohort 1 and 1b)
n=2 Participants
Participants in Part A Cohorts 1 and 1b were randomized to receive a single SC dose of placebo on Day 1.
|
Cohort 1 (Part A): AMG 171 Dose A
n=7 Participants
Participants were randomized to receive AMG 171 Dose A as a single SC dose on Day 1.
|
Cohort 1b (Part A): AMG 171 Dose B
n=6 Participants
Participants were randomized to receive AMG 171 Dose B as a single SC dose on Day 1.
|
Placebo (Cohort 4 Replaced)
Participants enrolled in Part C Cohort 4 received compromised or expired IP. These participants were randomized to receive placebo on Day 1, Day 15, and on Day 29, as SC doses.
|
Placebo (Cohorts 2-5)
Participants in Parts B and C (Cohorts 2-5) were randomized to receive multiple SC doses of placebo.
|
Cohort 2 (Part B): AMG 171 Dose A Q2W
n=7 Participants
Participants were randomized to receive AMG 171 Dose A Q2W on Days 1, 15, 29, 43, 57, and 71, as SC doses.
|
Cohort 3 (Part C): AMG 171 Dose A/Dose B
n=8 Participants
Participants were randomized to receive AMG 171 Dose A on Day 1 and Dose B on Day 15, as SC doses.
|
Cohort 4 (Part C): AMG 171 Dose A/Dose B/Dose C
n=6 Participants
Participants were randomized to receive AMG 171 Dose A on Day 1, Dose B on Day 15, and Dose C on Day 29, as SC doses.
|
Cohort 5 (Part C): AMG 171 Dose A/Dose B
n=6 Participants
Participants were randomized to receive AMG 171 Dose A on Day 1 and Dose B on Day 8, as SC doses.
|
Cohort 4 Replaced (Part C): AMG 171 Dose A/Dose B/Dose C
Participants enrolled in Part C Cohort 4 received compromised or expired IP. These participants were randomized to receive AMG 171 Dose A on Day 1, Dose B on Day 15, and Dose C on Day 29, as SC doses.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Anti-AMG 171 Antibodies
bAb +ve post-BL with -ve/no result at BL
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Anti-AMG 171 Antibodies
bAb +ve at/before BL
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Anti-AMG 171 Antibodies
nAb +ve at/before BL
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Anti-AMG 171 Antibodies
Transient bAb +ve post-BL with -ve/no result at BL
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Anti-AMG 171 Antibodies
nAb +ve post-BL with -ve/no result at BL
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Anti-AMG 171 Antibodies
Transient nAb +ve post-BL with -ve/no result at BL
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
Adverse Events
Placebo (Cohort 1 and 1b)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 1 (Part A): AMG 171 Dose A
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 1b (Part A): AMG 171 Dose B
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo (Cohort 4 Replaced)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo (Cohorts 2-5)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 2 (Part B): AMG 171 Dose A Q2W
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort 3 (Part C): AMG 171 Dose A/Dose B
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 4 (Part C): AMG 171 Dose A/Dose B/Dose C
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 5 (Part C): AMG 171 Dose A/Dose B
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 4 Replaced (Part C): AMG 171 Dose A/Dose B/Dose C
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo (Cohort 1 and 1b)
n=4 participants at risk
Participants in Part A Cohorts 1 and 1b were randomized to receive a single SC dose of placebo on Day 1.
|
Cohort 1 (Part A): AMG 171 Dose A
n=7 participants at risk
Participants were randomized to receive AMG 171 Dose A as a single SC dose on Day 1.
|
Cohort 1b (Part A): AMG 171 Dose B
n=6 participants at risk
Participants were randomized to receive AMG 171 Dose B as a single SC dose on Day 1.
|
Placebo (Cohort 4 Replaced)
n=2 participants at risk
Participants enrolled in Part C Cohort 4 received compromised or expired IP. These participants were randomized to receive placebo on Day 1, Day 15, and on Day 29, as SC doses.
|
Placebo (Cohorts 2-5)
n=8 participants at risk
Participants in Parts B and C (Cohorts 2-5) were randomized to receive multiple SC doses of placebo.
|
Cohort 2 (Part B): AMG 171 Dose A Q2W
n=7 participants at risk
Participants were randomized to receive AMG 171 Dose A Q2W on Days 1, 15, 29, 43, 57, and 71, as SC doses.
|
Cohort 3 (Part C): AMG 171 Dose A/Dose B
n=8 participants at risk
Participants were randomized to receive AMG 171 Dose A on Day 1 and Dose B on Day 15, as SC doses.
|
Cohort 4 (Part C): AMG 171 Dose A/Dose B/Dose C
n=6 participants at risk
Participants were randomized to receive AMG 171 Dose A on Day 1, Dose B on Day 15, and Dose C on Day 29, as SC doses.
|
Cohort 5 (Part C): AMG 171 Dose A/Dose B
n=6 participants at risk
Participants were randomized to receive AMG 171 Dose A on Day 1 and Dose B on Day 8, as SC doses.
|
Cohort 4 Replaced (Part C): AMG 171 Dose A/Dose B/Dose C
n=6 participants at risk
Participants enrolled in Part C Cohort 4 received compromised or expired IP. These participants were randomized to receive AMG 171 Dose A on Day 1, Dose B on Day 15, and Dose C on Day 29, as SC doses.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/4 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/4 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/4 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
33.3%
2/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Bowel movement irregularity
|
0.00%
0/4 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
50.0%
3/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/4 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/4 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
57.1%
4/7 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
100.0%
6/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
71.4%
5/7 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
50.0%
4/8 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
83.3%
5/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
66.7%
4/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
66.7%
4/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
66.7%
4/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
57.1%
4/7 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
33.3%
2/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
66.7%
4/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
33.3%
2/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Chest discomfort
|
0.00%
0/4 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
0.00%
0/4 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/4 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/4 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/4 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/4 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/4 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/4 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
25.0%
2/8 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/4 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
28.6%
2/7 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
37.5%
3/8 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
33.3%
2/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.00%
0/4 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/4 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/4 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/4 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
|
Vascular disorders
Hot flush
|
0.00%
0/4 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/2 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER