Trial Outcomes & Findings for v4 Study Evaluating the Safety, Tolerability and Preliminary Pharmacokinetics and Pharmacodynamics of MYK-491 (NCT NCT03447990)
NCT ID: NCT03447990
Last Updated: 2023-02-02
Results Overview
Number of participants with any grade of treatment-emergent adverse events (TEAEs) and any grade of serious adverse events (SAEs).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
52 participants
Primary outcome timeframe
From first dose to 30 days post last dose (Up to 2 months)
Results posted on
2023-02-02
Participant Flow
Participant milestones
| Measure |
SAD Cohort 1
Participants received 3 double-blinded single ascending doses in random sequence (1 placebo, Danicamtiv 175mg and Danicamtiv 350mg) in Period A, B, and C with intervals between doses ranging from 3 to 14 days. Some participants received a fourth single dose of Danicamtiv ranging between 350mg-550mg in the optional open-label period D
|
SAD Cohort 2
Participants received 3 double-blinded single ascending doses in random sequence (1 placebo, Danicamtiv 400mg and Danicamtiv 500mg) in Period A, B, and C with intervals between doses ranging from 3 to 14 days
|
MAD Cohort 1
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 75mg (fasting) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge.
|
MAD Cohort 2
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 50mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge.
|
MAD Cohort 3
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 75mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge.
|
MAD Cohort 4
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 100mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge.
|
MAD Placebo
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded placebo twice daily for 7 days, and 2 days of monitoring following the last dose before discharge.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
4
|
6
|
9
|
9
|
6
|
10
|
|
Overall Study
Completed Blinded Treatment Period A
|
8
|
4
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Completed Blinded Treatment Period B
|
8
|
4
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Completed Blinded Treatment Period C
|
8
|
4
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Completed Optional Open-Label Treatment Period D
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
8
|
4
|
6
|
9
|
9
|
6
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
SAD Cohort 1
Participants received 3 double-blinded single ascending doses in random sequence (1 placebo, Danicamtiv 175mg and Danicamtiv 350mg) in Period A, B, and C with intervals between doses ranging from 3 to 14 days. Some participants received a fourth single dose of Danicamtiv ranging between 350mg-550mg in the optional open-label period D
|
SAD Cohort 2
Participants received 3 double-blinded single ascending doses in random sequence (1 placebo, Danicamtiv 400mg and Danicamtiv 500mg) in Period A, B, and C with intervals between doses ranging from 3 to 14 days
|
MAD Cohort 1
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 75mg (fasting) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge.
|
MAD Cohort 2
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 50mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge.
|
MAD Cohort 3
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 75mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge.
|
MAD Cohort 4
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 100mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge.
|
MAD Placebo
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded placebo twice daily for 7 days, and 2 days of monitoring following the last dose before discharge.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
v4 Study Evaluating the Safety, Tolerability and Preliminary Pharmacokinetics and Pharmacodynamics of MYK-491
Baseline characteristics by cohort
| Measure |
SAD Cohort 1
n=8 Participants
Participants received 3 double-blinded single ascending doses in random sequence (1 placebo, Danicamtiv 175mg and Danicamtiv 350mg) in Period A, B, and C with intervals between doses ranging from 3 to 14 days. Some participants received a fourth single dose of Danicamtiv ranging between 350mg-550mg in the optional open-label period D
|
SAD Cohort 2
n=4 Participants
Participants received 3 double-blinded single ascending doses in random sequence (1 placebo, Danicamtiv 400mg and Danicamtiv 500mg) in Period A, B, and C with intervals between doses ranging from 3 to 14 days
|
MAD Cohort 1
n=6 Participants
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 75mg (fasting) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge.
|
MAD Cohort 2
n=9 Participants
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 50mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge.
|
MAD Cohort 3
n=9 Participants
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 75mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge.
|
MAD Cohort 4
n=6 Participants
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 100mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge.
|
MAD Placebo
n=10 Participants
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded placebo twice daily for 7 days, and 2 days of monitoring following the last dose before discharge.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
57.1 Years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
57.5 Years
STANDARD_DEVIATION 5.07 • n=7 Participants
|
62.7 Years
STANDARD_DEVIATION 12.50 • n=5 Participants
|
63.0 Years
STANDARD_DEVIATION 9.86 • n=4 Participants
|
56.8 Years
STANDARD_DEVIATION 5.09 • n=21 Participants
|
58.5 Years
STANDARD_DEVIATION 5.36 • n=8 Participants
|
58.6 Years
STANDARD_DEVIATION 6.98 • n=8 Participants
|
59.2 Years
STANDARD_DEVIATION 8.11 • n=24 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
14 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
38 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
51 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
16 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
36 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: From first dose to 30 days post last dose (Up to 2 months)Population: All treated participants per regimen dosage
Number of participants with any grade of treatment-emergent adverse events (TEAEs) and any grade of serious adverse events (SAEs).
Outcome measures
| Measure |
SAD Cohort 1 Danicamtiv 175mg
n=8 Participants
Participants received single dose of Danicamtiv 175mg in either period A, B, or C
|
SAD Cohort 1 Danicamtiv 350mg
n=8 Participants
Participants received single dose of Danicamtiv 350mg in either period A, B, C, or D
|
SAD Cohort 1 Placebo
n=8 Participants
Participants received single dose of Placebo in either period A, B, or C
|
SAD Cohort 1 Danicamtiv 450mg
n=1 Participants
Participants received split dose of Danicamtiv 450mg in period D
|
SAD Cohort 1 Danicamtiv 525mg
n=2 Participants
Participants received single dose of Danicamtiv 525mg in period D
|
SAD Cohort 1 Danicamtiv 550mg
n=2 Participants
Participants received split dose of Danicamtiv 550mg in period D
|
SAD Cohort 2 Danicamtiv 400mg
n=4 Participants
Participants received split dose of Danicamtiv 400mg
|
SAD Cohort 2 Danicamtiv 500mg
n=4 Participants
Participants received split dose of Danicamtiv 500mg
|
SAD Cohort 2 Placebo
n=4 Participants
Participants received single dose of Placebo
|
MAD Cohort 2 Danicamtiv 50mg
n=9 Participants
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 50mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort 1+3 Danicamtiv 75mg
n=15 Participants
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 75mg twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort 4 Danicamtiv 100mg
n=6 Participants
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 100mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort Placebo
n=10 Participants
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Placebo twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
TEAEs
|
2 Participants
|
5 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
7 Participants
|
6 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline, day 1-16, 2 hours pre-dose and at 3-, 5-, 9-, 12-, 24-, and 36-hours post-dosePopulation: All treated participants in SAD Cohorts per regimen dosage
Number of participants with change from baseline in ECGs QTcF, PR, and QRS intervals. Baseline is defined as the last non-missing value prior to the corresponding period.
Outcome measures
| Measure |
SAD Cohort 1 Danicamtiv 175mg
n=8 Participants
Participants received single dose of Danicamtiv 175mg in either period A, B, or C
|
SAD Cohort 1 Danicamtiv 350mg
n=8 Participants
Participants received single dose of Danicamtiv 350mg in either period A, B, C, or D
|
SAD Cohort 1 Placebo
n=8 Participants
Participants received single dose of Placebo in either period A, B, or C
|
SAD Cohort 1 Danicamtiv 450mg
n=1 Participants
Participants received split dose of Danicamtiv 450mg in period D
|
SAD Cohort 1 Danicamtiv 525mg
n=2 Participants
Participants received single dose of Danicamtiv 525mg in period D
|
SAD Cohort 1 Danicamtiv 550mg
n=2 Participants
Participants received split dose of Danicamtiv 550mg in period D
|
SAD Cohort 2 Danicamtiv 400mg
n=4 Participants
Participants received split dose of Danicamtiv 400mg
|
SAD Cohort 2 Danicamtiv 500mg
n=4 Participants
Participants received split dose of Danicamtiv 500mg
|
SAD Cohort 2 Placebo
n=4 Participants
Participants received single dose of Placebo
|
MAD Cohort 2 Danicamtiv 50mg
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 50mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort 1+3 Danicamtiv 75mg
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 75mg twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort 4 Danicamtiv 100mg
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 100mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort Placebo
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Placebo twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Change From Baseline in Electrocardiograms (ECG) Intervals - SAD Cohorts
Change in QTcF from Baseline > 60msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Change From Baseline in Electrocardiograms (ECG) Intervals - SAD Cohorts
Change in QTcF from Baseline > 30msec
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Change From Baseline in Electrocardiograms (ECG) Intervals - SAD Cohorts
Change in QRS from baseline > 25%
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Change From Baseline in Electrocardiograms (ECG) Intervals - SAD Cohorts
Change in PR from baseline > 25%
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, Day 1-16, 2 hours pre-dose and at 7-, 24-, and 48-hours post final dosePopulation: All treated participants in MAD Cohorts per regimen dosage
Number of participants with change from baseline in ECGs QTcF, PR, and QRS intervals. Baseline is defined as the last non-missing value prior to first randomized dose.
Outcome measures
| Measure |
SAD Cohort 1 Danicamtiv 175mg
n=9 Participants
Participants received single dose of Danicamtiv 175mg in either period A, B, or C
|
SAD Cohort 1 Danicamtiv 350mg
n=15 Participants
Participants received single dose of Danicamtiv 350mg in either period A, B, C, or D
|
SAD Cohort 1 Placebo
n=6 Participants
Participants received single dose of Placebo in either period A, B, or C
|
SAD Cohort 1 Danicamtiv 450mg
n=10 Participants
Participants received split dose of Danicamtiv 450mg in period D
|
SAD Cohort 1 Danicamtiv 525mg
Participants received single dose of Danicamtiv 525mg in period D
|
SAD Cohort 1 Danicamtiv 550mg
Participants received split dose of Danicamtiv 550mg in period D
|
SAD Cohort 2 Danicamtiv 400mg
Participants received split dose of Danicamtiv 400mg
|
SAD Cohort 2 Danicamtiv 500mg
Participants received split dose of Danicamtiv 500mg
|
SAD Cohort 2 Placebo
Participants received single dose of Placebo
|
MAD Cohort 2 Danicamtiv 50mg
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 50mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort 1+3 Danicamtiv 75mg
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 75mg twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort 4 Danicamtiv 100mg
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 100mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort Placebo
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Placebo twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Change From Baseline in Electrocardiograms (ECG) Intervals - MAD Cohorts
Change in QRS from baseline > 25%
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Change From Baseline in Electrocardiograms (ECG) Intervals - MAD Cohorts
Change in QTcF from Baseline > 30msec
|
2 Participants
|
5 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Change From Baseline in Electrocardiograms (ECG) Intervals - MAD Cohorts
Change in QTcF from Baseline > 60msec
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Change From Baseline in Electrocardiograms (ECG) Intervals - MAD Cohorts
Change in PR from baseline > 25%
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and at 6-hours post-dosePopulation: All treated participants in SAD Cohorts per regimen dosage
Mean change from baseline in supine systolic blood pressure (SBP) and supine diastolic blood pressure (DBP) vital signs. Baseline is defined as the last non-missing value prior to the corresponding period.
Outcome measures
| Measure |
SAD Cohort 1 Danicamtiv 175mg
n=8 Participants
Participants received single dose of Danicamtiv 175mg in either period A, B, or C
|
SAD Cohort 1 Danicamtiv 350mg
n=8 Participants
Participants received single dose of Danicamtiv 350mg in either period A, B, C, or D
|
SAD Cohort 1 Placebo
n=8 Participants
Participants received single dose of Placebo in either period A, B, or C
|
SAD Cohort 1 Danicamtiv 450mg
n=1 Participants
Participants received split dose of Danicamtiv 450mg in period D
|
SAD Cohort 1 Danicamtiv 525mg
n=2 Participants
Participants received single dose of Danicamtiv 525mg in period D
|
SAD Cohort 1 Danicamtiv 550mg
n=2 Participants
Participants received split dose of Danicamtiv 550mg in period D
|
SAD Cohort 2 Danicamtiv 400mg
n=4 Participants
Participants received split dose of Danicamtiv 400mg
|
SAD Cohort 2 Danicamtiv 500mg
n=4 Participants
Participants received split dose of Danicamtiv 500mg
|
SAD Cohort 2 Placebo
n=4 Participants
Participants received single dose of Placebo
|
MAD Cohort 2 Danicamtiv 50mg
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 50mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort 1+3 Danicamtiv 75mg
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 75mg twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort 4 Danicamtiv 100mg
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 100mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort Placebo
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Placebo twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Vital Signs Part 1 - SAD Cohorts
Supine SBP
|
-10.13 mmHg
Standard Deviation 12.23
|
-11.38 mmHg
Standard Deviation 9.90
|
-1.38 mmHg
Standard Deviation 15.02
|
16.00 mmHg
Standard Deviation NA
SD was not calculated because of insufficient number of events
|
-7.00 mmHg
Standard Deviation 19.80
|
-9.50 mmHg
Standard Deviation 2.12
|
2.50 mmHg
Standard Deviation 4.359
|
01.75 mmHg
Standard Deviation 15.650
|
0.00 mmHg
Standard Deviation 11.633
|
—
|
—
|
—
|
—
|
|
Mean Change From Baseline in Vital Signs Part 1 - SAD Cohorts
Supine DBP
|
-5.50 mmHg
Standard Deviation 12.14
|
9.50 mmHg
Standard Deviation 6.44
|
-5.75 mmHg
Standard Deviation 13.04
|
12.00 mmHg
Standard Deviation NA
SD was not calculated because of insufficient number of events
|
-1.00 mmHg
Standard Deviation 5.66
|
-4.00 mmHg
Standard Deviation 8.49
|
4.00 mmHg
Standard Deviation 9.933
|
-2.25 mmHg
Standard Deviation 17.270
|
-3.00 mmHg
Standard Deviation 14.674
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and at 6-hours post-dosePopulation: Pre-specified for data to be collected by combining all treated participants with vital signs measurements in MAD Cohorts per regimen only
Mean change from baseline in supine systolic blood pressure (SBP) and supine diastolic blood pressure (DBP) vital signs. Baseline is defined as the last non-missing value prior to first randomized dose
Outcome measures
| Measure |
SAD Cohort 1 Danicamtiv 175mg
n=7 Participants
Participants received single dose of Danicamtiv 175mg in either period A, B, or C
|
SAD Cohort 1 Danicamtiv 350mg
n=3 Participants
Participants received single dose of Danicamtiv 350mg in either period A, B, C, or D
|
SAD Cohort 1 Placebo
Participants received single dose of Placebo in either period A, B, or C
|
SAD Cohort 1 Danicamtiv 450mg
Participants received split dose of Danicamtiv 450mg in period D
|
SAD Cohort 1 Danicamtiv 525mg
Participants received single dose of Danicamtiv 525mg in period D
|
SAD Cohort 1 Danicamtiv 550mg
Participants received split dose of Danicamtiv 550mg in period D
|
SAD Cohort 2 Danicamtiv 400mg
Participants received split dose of Danicamtiv 400mg
|
SAD Cohort 2 Danicamtiv 500mg
Participants received split dose of Danicamtiv 500mg
|
SAD Cohort 2 Placebo
Participants received single dose of Placebo
|
MAD Cohort 2 Danicamtiv 50mg
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 50mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort 1+3 Danicamtiv 75mg
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 75mg twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort 4 Danicamtiv 100mg
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 100mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort Placebo
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Placebo twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Vital Signs Part 1 - MAD Cohorts
Supine DBP
|
-3.57 mmHg
Standard Deviation 7.323
|
-5.67 mmHg
Standard Deviation 3.055
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Change From Baseline in Vital Signs Part 1 - MAD Cohorts
Supine SBP
|
-4.86 mmHg
Standard Deviation 7.537
|
-6.33 mmHg
Standard Deviation 3.215
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and at 6-hours post-dosePopulation: All treated participants in SAD Cohorts per regimen dosage
Mean change from baseline in heart rate (HR) vital signs. Baseline is defined as the last non-missing value prior to the corresponding period.
Outcome measures
| Measure |
SAD Cohort 1 Danicamtiv 175mg
n=8 Participants
Participants received single dose of Danicamtiv 175mg in either period A, B, or C
|
SAD Cohort 1 Danicamtiv 350mg
n=8 Participants
Participants received single dose of Danicamtiv 350mg in either period A, B, C, or D
|
SAD Cohort 1 Placebo
n=8 Participants
Participants received single dose of Placebo in either period A, B, or C
|
SAD Cohort 1 Danicamtiv 450mg
n=1 Participants
Participants received split dose of Danicamtiv 450mg in period D
|
SAD Cohort 1 Danicamtiv 525mg
n=2 Participants
Participants received single dose of Danicamtiv 525mg in period D
|
SAD Cohort 1 Danicamtiv 550mg
n=2 Participants
Participants received split dose of Danicamtiv 550mg in period D
|
SAD Cohort 2 Danicamtiv 400mg
n=4 Participants
Participants received split dose of Danicamtiv 400mg
|
SAD Cohort 2 Danicamtiv 500mg
n=4 Participants
Participants received split dose of Danicamtiv 500mg
|
SAD Cohort 2 Placebo
n=4 Participants
Participants received single dose of Placebo
|
MAD Cohort 2 Danicamtiv 50mg
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 50mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort 1+3 Danicamtiv 75mg
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 75mg twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort 4 Danicamtiv 100mg
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 100mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort Placebo
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Placebo twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Vital Signs Part 2 - SAD Cohorts
|
7.13 Beats/min
Standard Deviation 6.20
|
-1.25 Beats/min
Standard Deviation 5.75
|
3.00 Beats/min
Standard Deviation 5.50
|
5.00 Beats/min
Standard Deviation NA
SD was not calculated because of insufficient number of events
|
5.50 Beats/min
Standard Deviation 0.71
|
-1.50 Beats/min
Standard Deviation 2.12
|
3.75 Beats/min
Standard Deviation 9.743
|
-0.50 Beats/min
Standard Deviation 5.000
|
-6.50 Beats/min
Standard Deviation 13.699
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and at 6-hours post-dosePopulation: Pre-specified for data to be collected by combining all treated participants with vital signs measurements in MAD Cohorts per regimen only
Mean change from baseline in heart rate (HR) vital signs. Baseline is defined as the last non-missing value prior to first randomized dose
Outcome measures
| Measure |
SAD Cohort 1 Danicamtiv 175mg
n=7 Participants
Participants received single dose of Danicamtiv 175mg in either period A, B, or C
|
SAD Cohort 1 Danicamtiv 350mg
n=3 Participants
Participants received single dose of Danicamtiv 350mg in either period A, B, C, or D
|
SAD Cohort 1 Placebo
Participants received single dose of Placebo in either period A, B, or C
|
SAD Cohort 1 Danicamtiv 450mg
Participants received split dose of Danicamtiv 450mg in period D
|
SAD Cohort 1 Danicamtiv 525mg
Participants received single dose of Danicamtiv 525mg in period D
|
SAD Cohort 1 Danicamtiv 550mg
Participants received split dose of Danicamtiv 550mg in period D
|
SAD Cohort 2 Danicamtiv 400mg
Participants received split dose of Danicamtiv 400mg
|
SAD Cohort 2 Danicamtiv 500mg
Participants received split dose of Danicamtiv 500mg
|
SAD Cohort 2 Placebo
Participants received single dose of Placebo
|
MAD Cohort 2 Danicamtiv 50mg
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 50mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort 1+3 Danicamtiv 75mg
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 75mg twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort 4 Danicamtiv 100mg
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 100mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort Placebo
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Placebo twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Vital Signs Part 2 - MAD Cohorts
|
3.71 Beats/min
Standard Deviation 2.563
|
3.33 Beats/min
Standard Deviation 2.517
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, day 1-3, 2 hours pre-dose and at 3-, 5-, 9-, 12-, 24-, and 36-hours post-dosePopulation: Pre-specified for data to be collected by combining all treated participants in SAD Cohorts per regimen only
Number of participants with a troponin increase is defined as when one of the following conditions was met (1) if the participant's troponin I value was normal prior to dosing (≤0.03 ng/mL), an elevated level on at least one measurement after start of dosing \>2×ULN for the specific assay (\>0.06 ng/mL) through Day 16. (2) If the participant's troponin I value was above the ULN for the specific assay prior to dosing, an increase \>0.03 ng/mL compared to baseline on at least one measurement after start of dosing through Day 16.
Outcome measures
| Measure |
SAD Cohort 1 Danicamtiv 175mg
n=12 Participants
Participants received single dose of Danicamtiv 175mg in either period A, B, or C
|
SAD Cohort 1 Danicamtiv 350mg
n=12 Participants
Participants received single dose of Danicamtiv 350mg in either period A, B, C, or D
|
SAD Cohort 1 Placebo
Participants received single dose of Placebo in either period A, B, or C
|
SAD Cohort 1 Danicamtiv 450mg
Participants received split dose of Danicamtiv 450mg in period D
|
SAD Cohort 1 Danicamtiv 525mg
Participants received single dose of Danicamtiv 525mg in period D
|
SAD Cohort 1 Danicamtiv 550mg
Participants received split dose of Danicamtiv 550mg in period D
|
SAD Cohort 2 Danicamtiv 400mg
Participants received split dose of Danicamtiv 400mg
|
SAD Cohort 2 Danicamtiv 500mg
Participants received split dose of Danicamtiv 500mg
|
SAD Cohort 2 Placebo
Participants received single dose of Placebo
|
MAD Cohort 2 Danicamtiv 50mg
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 50mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort 1+3 Danicamtiv 75mg
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 75mg twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort 4 Danicamtiv 100mg
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 100mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort Placebo
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Placebo twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With a Troponin I Increase - SAD Cohorts
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, pre-dose and 7hr post dose on treatment day 1, day 2, day 5 and pre-dose and at 7-, 24-, and 48-hours post final dosePopulation: Pre-specified for data to be collected by combining all treated participants in MAD Cohorts per regimen only
Number of participants with a troponin increase is defined as when one of the following conditions was met (1) if the participant's troponin I value was normal prior to dosing (≤0.03 ng/mL), an elevated level on at least one measurement after start of dosing \>2×ULN for the specific assay (\>0.06 ng/mL) through Day 16. (2) If the participant's troponin I value was above the ULN for the specific assay prior to dosing, an increase \>0.03 ng/mL compared to baseline on at least one measurement after start of dosing through Day 16.
Outcome measures
| Measure |
SAD Cohort 1 Danicamtiv 175mg
n=30 Participants
Participants received single dose of Danicamtiv 175mg in either period A, B, or C
|
SAD Cohort 1 Danicamtiv 350mg
n=10 Participants
Participants received single dose of Danicamtiv 350mg in either period A, B, C, or D
|
SAD Cohort 1 Placebo
Participants received single dose of Placebo in either period A, B, or C
|
SAD Cohort 1 Danicamtiv 450mg
Participants received split dose of Danicamtiv 450mg in period D
|
SAD Cohort 1 Danicamtiv 525mg
Participants received single dose of Danicamtiv 525mg in period D
|
SAD Cohort 1 Danicamtiv 550mg
Participants received split dose of Danicamtiv 550mg in period D
|
SAD Cohort 2 Danicamtiv 400mg
Participants received split dose of Danicamtiv 400mg
|
SAD Cohort 2 Danicamtiv 500mg
Participants received split dose of Danicamtiv 500mg
|
SAD Cohort 2 Placebo
Participants received single dose of Placebo
|
MAD Cohort 2 Danicamtiv 50mg
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 50mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort 1+3 Danicamtiv 75mg
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 75mg twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort 4 Danicamtiv 100mg
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 100mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort Placebo
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Placebo twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With a Troponin I Increase - MAD Cohorts
|
7 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From first dose to 30 days post last dose (Up to 2 months)Population: Pre-specified for data to be collected by combining all treated participants per SAD and MAD Cohort only
Number of participants with clinically significant laboratory abnormalities.
Outcome measures
| Measure |
SAD Cohort 1 Danicamtiv 175mg
n=12 Participants
Participants received single dose of Danicamtiv 175mg in either period A, B, or C
|
SAD Cohort 1 Danicamtiv 350mg
n=40 Participants
Participants received single dose of Danicamtiv 350mg in either period A, B, C, or D
|
SAD Cohort 1 Placebo
Participants received single dose of Placebo in either period A, B, or C
|
SAD Cohort 1 Danicamtiv 450mg
Participants received split dose of Danicamtiv 450mg in period D
|
SAD Cohort 1 Danicamtiv 525mg
Participants received single dose of Danicamtiv 525mg in period D
|
SAD Cohort 1 Danicamtiv 550mg
Participants received split dose of Danicamtiv 550mg in period D
|
SAD Cohort 2 Danicamtiv 400mg
Participants received split dose of Danicamtiv 400mg
|
SAD Cohort 2 Danicamtiv 500mg
Participants received split dose of Danicamtiv 500mg
|
SAD Cohort 2 Placebo
Participants received single dose of Placebo
|
MAD Cohort 2 Danicamtiv 50mg
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 50mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort 1+3 Danicamtiv 75mg
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 75mg twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort 4 Danicamtiv 100mg
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 100mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort Placebo
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Placebo twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From first dose to 30 days post last dose (Up to 2 months)Population: Pre-specified for data to be collected by combining all treated participants per SAD and MAD Cohort only
Number of participants with clinically significant physical examinations abnormalities.
Outcome measures
| Measure |
SAD Cohort 1 Danicamtiv 175mg
n=12 Participants
Participants received single dose of Danicamtiv 175mg in either period A, B, or C
|
SAD Cohort 1 Danicamtiv 350mg
n=40 Participants
Participants received single dose of Danicamtiv 350mg in either period A, B, C, or D
|
SAD Cohort 1 Placebo
Participants received single dose of Placebo in either period A, B, or C
|
SAD Cohort 1 Danicamtiv 450mg
Participants received split dose of Danicamtiv 450mg in period D
|
SAD Cohort 1 Danicamtiv 525mg
Participants received single dose of Danicamtiv 525mg in period D
|
SAD Cohort 1 Danicamtiv 550mg
Participants received split dose of Danicamtiv 550mg in period D
|
SAD Cohort 2 Danicamtiv 400mg
Participants received split dose of Danicamtiv 400mg
|
SAD Cohort 2 Danicamtiv 500mg
Participants received split dose of Danicamtiv 500mg
|
SAD Cohort 2 Placebo
Participants received single dose of Placebo
|
MAD Cohort 2 Danicamtiv 50mg
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 50mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort 1+3 Danicamtiv 75mg
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 75mg twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort 4 Danicamtiv 100mg
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 100mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort Placebo
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Placebo twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Physical Examinations Abnormalities
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 hour pre-dose and day 1-12 at 1, 2, 3, 4, 5, 6, 9, 12, 18, 24, 36, and 48 hours postdosePopulation: All participants that received Danicamtiv with plasma concertation data
Maximum observed plasma concentration (Cmax) for Danicamtiv. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.
Outcome measures
| Measure |
SAD Cohort 1 Danicamtiv 175mg
n=8 Participants
Participants received single dose of Danicamtiv 175mg in either period A, B, or C
|
SAD Cohort 1 Danicamtiv 350mg
n=8 Participants
Participants received single dose of Danicamtiv 350mg in either period A, B, C, or D
|
SAD Cohort 1 Placebo
n=1 Participants
Participants received single dose of Placebo in either period A, B, or C
|
SAD Cohort 1 Danicamtiv 450mg
n=1 Participants
Participants received split dose of Danicamtiv 450mg in period D
|
SAD Cohort 1 Danicamtiv 525mg
n=2 Participants
Participants received single dose of Danicamtiv 525mg in period D
|
SAD Cohort 1 Danicamtiv 550mg
n=2 Participants
Participants received split dose of Danicamtiv 550mg in period D
|
SAD Cohort 2 Danicamtiv 400mg
n=4 Participants
Participants received split dose of Danicamtiv 400mg
|
SAD Cohort 2 Danicamtiv 500mg
n=4 Participants
Participants received split dose of Danicamtiv 500mg
|
SAD Cohort 2 Placebo
n=8 Participants
Participants received single dose of Placebo
|
MAD Cohort 2 Danicamtiv 50mg
n=15 Participants
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 50mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort 1+3 Danicamtiv 75mg
n=6 Participants
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 75mg twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort 4 Danicamtiv 100mg
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 100mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort Placebo
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Placebo twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Danicamtiv Maximum Observed Plasma Concentration (Cmax)
|
1476.63 ng/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 22.72
|
2655.83 ng/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 29.47
|
4420.00 ng/mL
Geometric Coefficient of Variation NA
Coefficient of variation was not calculated because of insufficient number of events
|
3590.00 ng/mL
Geometric Coefficient of Variation NA
Coefficient of variation was not calculated because of insufficient number of events
|
2718.51 ng/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 4.68
|
5263.71 ng/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 9.28
|
5337.58 ng/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 24.65
|
5740.50 ng/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 25.86
|
792.5 ng/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 20.2
|
1174.3 ng/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 19.1
|
1452.8 ng/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 21.9
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 hour pre-dose and day 1-12 at 1, 2, 3, 4, 5, 6, 9, 12, 18, 24, 36, and 48 hours postdosePopulation: All participants that received Danicamtiv with plasma concertation data
Time of maximum observed plasma concentration (Tmax) for Danicamtiv.
Outcome measures
| Measure |
SAD Cohort 1 Danicamtiv 175mg
n=8 Participants
Participants received single dose of Danicamtiv 175mg in either period A, B, or C
|
SAD Cohort 1 Danicamtiv 350mg
n=8 Participants
Participants received single dose of Danicamtiv 350mg in either period A, B, C, or D
|
SAD Cohort 1 Placebo
n=1 Participants
Participants received single dose of Placebo in either period A, B, or C
|
SAD Cohort 1 Danicamtiv 450mg
n=1 Participants
Participants received split dose of Danicamtiv 450mg in period D
|
SAD Cohort 1 Danicamtiv 525mg
n=2 Participants
Participants received single dose of Danicamtiv 525mg in period D
|
SAD Cohort 1 Danicamtiv 550mg
n=2 Participants
Participants received split dose of Danicamtiv 550mg in period D
|
SAD Cohort 2 Danicamtiv 400mg
n=4 Participants
Participants received split dose of Danicamtiv 400mg
|
SAD Cohort 2 Danicamtiv 500mg
n=4 Participants
Participants received split dose of Danicamtiv 500mg
|
SAD Cohort 2 Placebo
n=8 Participants
Participants received single dose of Placebo
|
MAD Cohort 2 Danicamtiv 50mg
n=15 Participants
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 50mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort 1+3 Danicamtiv 75mg
n=6 Participants
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 75mg twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort 4 Danicamtiv 100mg
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 100mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort Placebo
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Placebo twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Danicamtiv Time of Maximum Observed Plasma Concentration (Tmax)
|
5.14 hours
Interval 2.0 to 6.3
|
6.18 hours
Interval 3.7 to 9.1
|
12.0 hours
Interval 12.0 to 12.0
|
4.1 hours
Interval 4.1 to 4.1
|
5.74 hours
Interval 5.4 to 6.1
|
8.93 hours
Interval 7.9 to 9.9
|
9.13 hours
Interval 6.0 to 12.2
|
9.08 hours
Interval 6.0 to 10.0
|
4.983 hours
Interval 3.0 to 9.0
|
4.000 hours
Interval 1.0 to 12.05
|
3.500 hours
Interval 2.03 to 9.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 hour pre-dose and day 1-12 at 1, 2, 3, 4, 5, 6, 9, 12, 18, 24, 36, and 48 hours postdosePopulation: All participants that received Danicamtiv with plasma concertation data
Area under the plasma concentration-time curve (AUC) for Danicamtiv including the following time points: (AUC(0-12))=from time 0 to 12 hours; (AUC(0-24))=from time 0 to 24 hours; (AUC(0-48))=from time 0 to 48 hours; (AUClast)=from time 0 up to the last measurable concentration; (AUC(0-∞))=from time 0 to infinity. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.
Outcome measures
| Measure |
SAD Cohort 1 Danicamtiv 175mg
n=8 Participants
Participants received single dose of Danicamtiv 175mg in either period A, B, or C
|
SAD Cohort 1 Danicamtiv 350mg
n=8 Participants
Participants received single dose of Danicamtiv 350mg in either period A, B, C, or D
|
SAD Cohort 1 Placebo
n=1 Participants
Participants received single dose of Placebo in either period A, B, or C
|
SAD Cohort 1 Danicamtiv 450mg
n=1 Participants
Participants received split dose of Danicamtiv 450mg in period D
|
SAD Cohort 1 Danicamtiv 525mg
n=2 Participants
Participants received single dose of Danicamtiv 525mg in period D
|
SAD Cohort 1 Danicamtiv 550mg
n=2 Participants
Participants received split dose of Danicamtiv 550mg in period D
|
SAD Cohort 2 Danicamtiv 400mg
n=4 Participants
Participants received split dose of Danicamtiv 400mg
|
SAD Cohort 2 Danicamtiv 500mg
n=4 Participants
Participants received split dose of Danicamtiv 500mg
|
SAD Cohort 2 Placebo
n=8 Participants
Participants received single dose of Placebo
|
MAD Cohort 2 Danicamtiv 50mg
n=15 Participants
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 50mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort 1+3 Danicamtiv 75mg
n=6 Participants
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 75mg twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort 4 Danicamtiv 100mg
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 100mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort Placebo
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Placebo twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Curve (AUC)
(AUC(0-24))
|
26411.97 hr x ng/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 21.31
|
48981.93 hr x ng/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 27.15
|
79175.02 hr x ng/mL
Geometric Coefficient of Variation NA
Coefficient of variation was not calculated because of insufficient number of events
|
70138.66 hr x ng/mL
Geometric Coefficient of Variation NA
Coefficient of variation was not calculated because of insufficient number of events
|
54004.82 hr x ng/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 4.58
|
97640.90 hr x ng/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 10.10
|
86110.51 hr x ng/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 17.56
|
97656.38 hr x ng/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 15.82
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Plasma Concentration-Time Curve (AUC)
(AUC(0-∞))
|
52467.20 hr x ng/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 24.00
|
99576.37 hr x ng/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 29.22
|
234888.37 hr x ng/mL
Geometric Coefficient of Variation NA
Coefficient of variation was not calculated because of insufficient number of events
|
—
|
126374.56 hr x ng/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 16.01
|
211928.81 hr x ng/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 16.99
|
187776.56 hr x ng/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 23.32
|
225087.02 hr x ng/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 28.27
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Plasma Concentration-Time Curve (AUC)
(AUC(0-12))
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
7169.245 hr x ng/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 18.6
|
10310.794 hr x ng/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 20.4
|
12728.956 hr x ng/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 16.8
|
—
|
—
|
|
Area Under the Plasma Concentration-Time Curve (AUC)
(AUC(0-48))
|
40068.47 hr x ng/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 20.91
|
76497.78 hr x ng/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 27.81
|
143543.52 hr x ng/mL
Geometric Coefficient of Variation NA
Coefficient of variation was not calculated because of insufficient number of events
|
89356.54 hr x ng/mL
Geometric Coefficient of Variation NA
Coefficient of variation was not calculated because of insufficient number of events
|
89341.77 hr x ng/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 2.23
|
159193.47 hr x ng/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 14.28
|
135385.91 hr x ng/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 12.21
|
161073.09 hr x ng/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 4.99
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Plasma Concentration-Time Curve (AUC)
(AUC last)
|
46750.66 hr x ng/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 21.87
|
89216.40 hr x ng/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 28.49
|
182804.71 hr x ng/mL
Geometric Coefficient of Variation NA
Coefficient of variation was not calculated because of insufficient number of events
|
104060.46 hr x ng/mL
Geometric Coefficient of Variation NA
Coefficient of variation was not calculated because of insufficient number of events
|
106987.30 hr x ng/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 3.02
|
188544.49 hr x ng/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 16.28
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 hour pre-dose and day 1-12 at 1, 2, 3, 4, 5, 6, 9, 12, 18, 24, 36, and 48 hours postdosePopulation: All participants that received Danicamtiv with plasma concertation data
Apparent first-order terminal elimination half-life (t1/2).
Outcome measures
| Measure |
SAD Cohort 1 Danicamtiv 175mg
n=8 Participants
Participants received single dose of Danicamtiv 175mg in either period A, B, or C
|
SAD Cohort 1 Danicamtiv 350mg
n=8 Participants
Participants received single dose of Danicamtiv 350mg in either period A, B, C, or D
|
SAD Cohort 1 Placebo
n=1 Participants
Participants received single dose of Placebo in either period A, B, or C
|
SAD Cohort 1 Danicamtiv 450mg
Participants received split dose of Danicamtiv 450mg in period D
|
SAD Cohort 1 Danicamtiv 525mg
n=2 Participants
Participants received single dose of Danicamtiv 525mg in period D
|
SAD Cohort 1 Danicamtiv 550mg
n=2 Participants
Participants received split dose of Danicamtiv 550mg in period D
|
SAD Cohort 2 Danicamtiv 400mg
n=4 Participants
Participants received split dose of Danicamtiv 400mg
|
SAD Cohort 2 Danicamtiv 500mg
n=4 Participants
Participants received split dose of Danicamtiv 500mg
|
SAD Cohort 2 Placebo
n=8 Participants
Participants received single dose of Placebo
|
MAD Cohort 2 Danicamtiv 50mg
n=13 Participants
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 50mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort 1+3 Danicamtiv 75mg
n=6 Participants
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 75mg twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort 4 Danicamtiv 100mg
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 100mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort Placebo
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Placebo twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent First-order Terminal Elimination Half-life (t1/2)
|
21.96 hours
Standard Deviation 4.40
|
20.95 hours
Standard Deviation 3.23
|
30.62 hours
Standard Deviation NA
SD was not calculated because of insufficient number of events
|
—
|
24.73 hours
Standard Deviation 10.76
|
21.45 hours
Standard Deviation 0.30
|
24.45 hours
Standard Deviation 11.363
|
24.30 hours
Standard Deviation 13.987
|
24.466 hours
Standard Deviation 5.8911
|
20.573 hours
Standard Deviation 6.1033
|
23.319 hours
Standard Deviation 3.5903
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 hour pre-dose and day 1-12 at 1, 2, 3, 4, 5, 6, 9, 12, 18, 24, 36, and 48 hours postdosePopulation: All participants in MAD Cohorts that received Danicamtiv with plasma concertation data
Accumulation ratio for maximum observed plasma concentration AR(Cmax) for Danicamtiv. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.
Outcome measures
| Measure |
SAD Cohort 1 Danicamtiv 175mg
n=8 Participants
Participants received single dose of Danicamtiv 175mg in either period A, B, or C
|
SAD Cohort 1 Danicamtiv 350mg
n=14 Participants
Participants received single dose of Danicamtiv 350mg in either period A, B, C, or D
|
SAD Cohort 1 Placebo
n=6 Participants
Participants received single dose of Placebo in either period A, B, or C
|
SAD Cohort 1 Danicamtiv 450mg
Participants received split dose of Danicamtiv 450mg in period D
|
SAD Cohort 1 Danicamtiv 525mg
Participants received single dose of Danicamtiv 525mg in period D
|
SAD Cohort 1 Danicamtiv 550mg
Participants received split dose of Danicamtiv 550mg in period D
|
SAD Cohort 2 Danicamtiv 400mg
Participants received split dose of Danicamtiv 400mg
|
SAD Cohort 2 Danicamtiv 500mg
Participants received split dose of Danicamtiv 500mg
|
SAD Cohort 2 Placebo
Participants received single dose of Placebo
|
MAD Cohort 2 Danicamtiv 50mg
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 50mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort 1+3 Danicamtiv 75mg
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 75mg twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort 4 Danicamtiv 100mg
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 100mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort Placebo
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Placebo twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Danicamtiv Accumulation Ratio for Maximum Observed Plasma Concentration AR(Cmax) - MAD Cohorts
|
3.451 ng/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 28.0
|
3.241 ng/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 30.2
|
3.827 ng/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 hour pre-dose and day 1-12 at 1, 2, 3, 4, 5, 6, 9, 12, 18, 24, 36, and 48 hours postdosePopulation: All participants in MAD Cohorts that received Danicamtiv with plasma concertation data
Accumulation ratio for area under the plasma concentration-time curve from time 0 to 12 hours AR(AUC(0-12)) for Danicamtiv. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.
Outcome measures
| Measure |
SAD Cohort 1 Danicamtiv 175mg
n=8 Participants
Participants received single dose of Danicamtiv 175mg in either period A, B, or C
|
SAD Cohort 1 Danicamtiv 350mg
n=14 Participants
Participants received single dose of Danicamtiv 350mg in either period A, B, C, or D
|
SAD Cohort 1 Placebo
n=6 Participants
Participants received single dose of Placebo in either period A, B, or C
|
SAD Cohort 1 Danicamtiv 450mg
Participants received split dose of Danicamtiv 450mg in period D
|
SAD Cohort 1 Danicamtiv 525mg
Participants received single dose of Danicamtiv 525mg in period D
|
SAD Cohort 1 Danicamtiv 550mg
Participants received split dose of Danicamtiv 550mg in period D
|
SAD Cohort 2 Danicamtiv 400mg
Participants received split dose of Danicamtiv 400mg
|
SAD Cohort 2 Danicamtiv 500mg
Participants received split dose of Danicamtiv 500mg
|
SAD Cohort 2 Placebo
Participants received single dose of Placebo
|
MAD Cohort 2 Danicamtiv 50mg
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 50mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort 1+3 Danicamtiv 75mg
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 75mg twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort 4 Danicamtiv 100mg
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 100mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort Placebo
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Placebo twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Accumulation Ratio for Area Under the Plasma Concentration-Time Curve From Time 0 to 12 Hours AR(AUC(0-12)) - MAD Cohorts
|
3.983 hr x ng/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 26.5
|
3.696 hr x ng/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 36.4
|
4.607 hr x ng/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 16.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, predose and at 3, 6, 9, and 24 hours post dosePopulation: All treated participants in SAD Cohorts per Danicamtiv plasma concentration ranges (Reporting arms are not mutually exclusive)
Mean change from baseline in TTE parameter systolic ejection time (SET) according to Danicamtiv plasma concentration ranges. Baseline is defined as the last non-missing value prior to the corresponding period. Reporting arms are not mutually exclusive
Outcome measures
| Measure |
SAD Cohort 1 Danicamtiv 175mg
n=7 Participants
Participants received single dose of Danicamtiv 175mg in either period A, B, or C
|
SAD Cohort 1 Danicamtiv 350mg
n=12 Participants
Participants received single dose of Danicamtiv 350mg in either period A, B, C, or D
|
SAD Cohort 1 Placebo
Participants received single dose of Placebo in either period A, B, or C
|
SAD Cohort 1 Danicamtiv 450mg
Participants received split dose of Danicamtiv 450mg in period D
|
SAD Cohort 1 Danicamtiv 525mg
Participants received single dose of Danicamtiv 525mg in period D
|
SAD Cohort 1 Danicamtiv 550mg
Participants received split dose of Danicamtiv 550mg in period D
|
SAD Cohort 2 Danicamtiv 400mg
Participants received split dose of Danicamtiv 400mg
|
SAD Cohort 2 Danicamtiv 500mg
Participants received split dose of Danicamtiv 500mg
|
SAD Cohort 2 Placebo
Participants received single dose of Placebo
|
MAD Cohort 2 Danicamtiv 50mg
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 50mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort 1+3 Danicamtiv 75mg
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 75mg twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort 4 Danicamtiv 100mg
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 100mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort Placebo
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Placebo twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Transthoracic Echocardiogram (TTE) Parameter 1 - SAD Cohorts
|
8.04 msec
Standard Error 10.03
|
36.3 msec
Standard Error 8.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, predose and at 3, 6, 9, and 24 hours post dosePopulation: All treated participants in SAD Cohorts per Danicamtiv plasma concentration ranges (Reporting arms are not mutually exclusive)
Mean change from baseline in TTE parameter left ventricular stroke volume (LVSV) according to Danicamtiv plasma concentration ranges. Baseline is defined as the last non-missing value prior to the corresponding period. Reporting arms are not mutually exclusive
Outcome measures
| Measure |
SAD Cohort 1 Danicamtiv 175mg
n=7 Participants
Participants received single dose of Danicamtiv 175mg in either period A, B, or C
|
SAD Cohort 1 Danicamtiv 350mg
n=12 Participants
Participants received single dose of Danicamtiv 350mg in either period A, B, C, or D
|
SAD Cohort 1 Placebo
Participants received single dose of Placebo in either period A, B, or C
|
SAD Cohort 1 Danicamtiv 450mg
Participants received split dose of Danicamtiv 450mg in period D
|
SAD Cohort 1 Danicamtiv 525mg
Participants received single dose of Danicamtiv 525mg in period D
|
SAD Cohort 1 Danicamtiv 550mg
Participants received split dose of Danicamtiv 550mg in period D
|
SAD Cohort 2 Danicamtiv 400mg
Participants received split dose of Danicamtiv 400mg
|
SAD Cohort 2 Danicamtiv 500mg
Participants received split dose of Danicamtiv 500mg
|
SAD Cohort 2 Placebo
Participants received single dose of Placebo
|
MAD Cohort 2 Danicamtiv 50mg
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 50mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort 1+3 Danicamtiv 75mg
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 75mg twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort 4 Danicamtiv 100mg
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 100mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort Placebo
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Placebo twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Transthoracic Echocardiogram (TTE) Parameter 2 - SAD Cohorts
|
1.01 mL
Standard Error 3.67
|
9.01 mL
Standard Error 2.99
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, predose and at 3, 6, 9, and 24 hours post dosePopulation: All treated participants in SAD Cohorts per Danicamtiv plasma concentration ranges (Reporting arms are not mutually exclusive)
Mean change from baseline in TTE parameter left ventricular ejection fraction (LVEF) and left ventricular fractional shortening (LVFS) according to Danicamtiv plasma concentration ranges. Baseline is defined as the last non-missing value prior to the corresponding period. Reporting arms are not mutually exclusive
Outcome measures
| Measure |
SAD Cohort 1 Danicamtiv 175mg
n=7 Participants
Participants received single dose of Danicamtiv 175mg in either period A, B, or C
|
SAD Cohort 1 Danicamtiv 350mg
n=12 Participants
Participants received single dose of Danicamtiv 350mg in either period A, B, C, or D
|
SAD Cohort 1 Placebo
Participants received single dose of Placebo in either period A, B, or C
|
SAD Cohort 1 Danicamtiv 450mg
Participants received split dose of Danicamtiv 450mg in period D
|
SAD Cohort 1 Danicamtiv 525mg
Participants received single dose of Danicamtiv 525mg in period D
|
SAD Cohort 1 Danicamtiv 550mg
Participants received split dose of Danicamtiv 550mg in period D
|
SAD Cohort 2 Danicamtiv 400mg
Participants received split dose of Danicamtiv 400mg
|
SAD Cohort 2 Danicamtiv 500mg
Participants received split dose of Danicamtiv 500mg
|
SAD Cohort 2 Placebo
Participants received single dose of Placebo
|
MAD Cohort 2 Danicamtiv 50mg
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 50mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort 1+3 Danicamtiv 75mg
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 75mg twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort 4 Danicamtiv 100mg
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 100mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort Placebo
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Placebo twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Transthoracic Echocardiogram (TTE) Parameter 3 - SAD Cohorts
LVEF
|
4.06 Percentage of blood pumped from LV
Standard Error 2.27
|
4.44 Percentage of blood pumped from LV
Standard Error 1.86
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Change From Baseline in Transthoracic Echocardiogram (TTE) Parameter 3 - SAD Cohorts
LVFS
|
3.14 Percentage of blood pumped from LV
Standard Error 1.36
|
2.81 Percentage of blood pumped from LV
Standard Error 1.12
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, predose, and at 7 hours post dose on day 1,2,3, 4, 7, 9, 10, and 11Population: All treated participants in MAD Cohorts per Danicamtiv plasma concentration ranges (Reporting arms are not mutually exclusive)
Mean change from baseline in TTE parameter systolic ejection time (SET) according to Danicamtiv plasma concentration ranges. Baseline is defined as the last non-missing value prior to first randomized dose. Reporting arms are not mutually exclusive
Outcome measures
| Measure |
SAD Cohort 1 Danicamtiv 175mg
n=30 Participants
Participants received single dose of Danicamtiv 175mg in either period A, B, or C
|
SAD Cohort 1 Danicamtiv 350mg
n=26 Participants
Participants received single dose of Danicamtiv 350mg in either period A, B, C, or D
|
SAD Cohort 1 Placebo
n=13 Participants
Participants received single dose of Placebo in either period A, B, or C
|
SAD Cohort 1 Danicamtiv 450mg
Participants received split dose of Danicamtiv 450mg in period D
|
SAD Cohort 1 Danicamtiv 525mg
Participants received single dose of Danicamtiv 525mg in period D
|
SAD Cohort 1 Danicamtiv 550mg
Participants received split dose of Danicamtiv 550mg in period D
|
SAD Cohort 2 Danicamtiv 400mg
Participants received split dose of Danicamtiv 400mg
|
SAD Cohort 2 Danicamtiv 500mg
Participants received split dose of Danicamtiv 500mg
|
SAD Cohort 2 Placebo
Participants received single dose of Placebo
|
MAD Cohort 2 Danicamtiv 50mg
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 50mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort 1+3 Danicamtiv 75mg
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 75mg twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort 4 Danicamtiv 100mg
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 100mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort Placebo
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Placebo twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Transthoracic Echocardiogram (TTE) Parameter 1 - MAD Cohorts
|
15.1 msec
Standard Error 3.51
|
35.6 msec
Standard Error 3.78
|
48.3 msec
Standard Error 4.68
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, predose, and at 7 hours post dose on day 1,2,3, 4, 7, 9, 10, and 11Population: All treated participants in MAD Cohorts per Danicamtiv plasma concentration ranges (Reporting arms are not mutually exclusive)
Mean change from baseline in TTE parameter left ventricular stroke volume (LVSV) according to Danicamtiv plasma concentration ranges. Baseline is defined as the last non-missing value prior to first randomized dose. Reporting arms are not mutually exclusive
Outcome measures
| Measure |
SAD Cohort 1 Danicamtiv 175mg
n=30 Participants
Participants received single dose of Danicamtiv 175mg in either period A, B, or C
|
SAD Cohort 1 Danicamtiv 350mg
n=26 Participants
Participants received single dose of Danicamtiv 350mg in either period A, B, C, or D
|
SAD Cohort 1 Placebo
n=13 Participants
Participants received single dose of Placebo in either period A, B, or C
|
SAD Cohort 1 Danicamtiv 450mg
Participants received split dose of Danicamtiv 450mg in period D
|
SAD Cohort 1 Danicamtiv 525mg
Participants received single dose of Danicamtiv 525mg in period D
|
SAD Cohort 1 Danicamtiv 550mg
Participants received split dose of Danicamtiv 550mg in period D
|
SAD Cohort 2 Danicamtiv 400mg
Participants received split dose of Danicamtiv 400mg
|
SAD Cohort 2 Danicamtiv 500mg
Participants received split dose of Danicamtiv 500mg
|
SAD Cohort 2 Placebo
Participants received single dose of Placebo
|
MAD Cohort 2 Danicamtiv 50mg
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 50mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort 1+3 Danicamtiv 75mg
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 75mg twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort 4 Danicamtiv 100mg
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 100mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort Placebo
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Placebo twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Transthoracic Echocardiogram (TTE) Parameter 2 - MAD Cohorts
|
3.126 mL
Standard Error 1.8348
|
7.843 mL
Standard Error 1.9511
|
5.685 mL
Standard Error 2.4988
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, predose, and at 7 hours post dose on day 1,2,3, 4, 7, 9, 10, and 11Population: All treated participants in MAD Cohorts per Danicamtiv plasma concentration ranges (Reporting arms are not mutually exclusive)
Mean change from baseline in TTE parameter left ventricular ejection fraction (LVEF) and left ventricular fractional shortening (LVFS) according to Danicamtiv plasma concentration ranges. Baseline is defined as the last non-missing value prior to first randomized dose. Reporting arms are not mutually exclusive
Outcome measures
| Measure |
SAD Cohort 1 Danicamtiv 175mg
n=30 Participants
Participants received single dose of Danicamtiv 175mg in either period A, B, or C
|
SAD Cohort 1 Danicamtiv 350mg
n=26 Participants
Participants received single dose of Danicamtiv 350mg in either period A, B, C, or D
|
SAD Cohort 1 Placebo
n=13 Participants
Participants received single dose of Placebo in either period A, B, or C
|
SAD Cohort 1 Danicamtiv 450mg
Participants received split dose of Danicamtiv 450mg in period D
|
SAD Cohort 1 Danicamtiv 525mg
Participants received single dose of Danicamtiv 525mg in period D
|
SAD Cohort 1 Danicamtiv 550mg
Participants received split dose of Danicamtiv 550mg in period D
|
SAD Cohort 2 Danicamtiv 400mg
Participants received split dose of Danicamtiv 400mg
|
SAD Cohort 2 Danicamtiv 500mg
Participants received split dose of Danicamtiv 500mg
|
SAD Cohort 2 Placebo
Participants received single dose of Placebo
|
MAD Cohort 2 Danicamtiv 50mg
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 50mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort 1+3 Danicamtiv 75mg
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 75mg twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort 4 Danicamtiv 100mg
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 100mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort Placebo
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Placebo twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Transthoracic Echocardiogram (TTE) Parameter 3 - MAD Cohorts
LVEF
|
-0.25 Percentage of blood pumped from LV
Standard Error 0.872
|
1.12 Percentage of blood pumped from LV
Standard Error 0.928
|
2.29 Percentage of blood pumped from LV
Standard Error 1.158
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Change From Baseline in Transthoracic Echocardiogram (TTE) Parameter 3 - MAD Cohorts
LVFS
|
0.46 Percentage of blood pumped from LV
Standard Error 0.537
|
0.78 Percentage of blood pumped from LV
Standard Error 0.574
|
0.51 Percentage of blood pumped from LV
Standard Error 0.725
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
SAD Cohort 1 Danicamtiv 175mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
SAD Cohort 1 Danicamtiv 350mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
SAD Cohort 1 Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
SAD Cohort 1 Danicamtiv Optional Period D
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
SAD Cohort 2 Danicamtiv 400mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
SAD Cohort 2 Danicamtiv 500mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SAD Cohort 2 Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
MAD Cohort 1 Danicamtiv 75mg
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
MAD Cohort 1 Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
MAD Cohort 2 Danicamtiv 50mg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
MAD Cohort 2 Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
MAD Cohort 3 Danicamtiv 75mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
MAD Cohort 3 Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
MAD Cohort 4 Danicamtiv 100mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
MAD Cohort 4 Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SAD Cohort 1 Danicamtiv 175mg
n=8 participants at risk
Participants received single dose of Danicamtiv 175mg in either period A, B, or C
|
SAD Cohort 1 Danicamtiv 350mg
n=8 participants at risk
Participants received single dose of Danicamtiv 350mg in either period A, B, C, or D
|
SAD Cohort 1 Placebo
n=8 participants at risk
Participants received single dose of Placebo in either period A, B, or C
|
SAD Cohort 1 Danicamtiv Optional Period D
n=6 participants at risk
Participants received Danicamtiv at either 450mg, 525mg or 550mg in period D
|
SAD Cohort 2 Danicamtiv 400mg
n=4 participants at risk
Participants received split dose of Danicamtiv 400mg
|
SAD Cohort 2 Danicamtiv 500mg
n=4 participants at risk
Participants received split dose of Danicamtiv 500mg
|
SAD Cohort 2 Placebo
n=4 participants at risk
Participants received single dose of Placebo
|
MAD Cohort 1 Danicamtiv 75mg
n=6 participants at risk
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 75mg twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort 1 Placebo
n=2 participants at risk
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Placebo twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort 2 Danicamtiv 50mg
n=9 participants at risk
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 50mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort 2 Placebo
n=3 participants at risk
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Placebo twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort 3 Danicamtiv 75mg
n=9 participants at risk
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 75mg twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort 3 Placebo
n=3 participants at risk
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Placebo twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort 4 Danicamtiv 100mg
n=6 participants at risk
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 100mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort 4 Placebo
n=2 participants at risk
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Placebo twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
Other adverse events
| Measure |
SAD Cohort 1 Danicamtiv 175mg
n=8 participants at risk
Participants received single dose of Danicamtiv 175mg in either period A, B, or C
|
SAD Cohort 1 Danicamtiv 350mg
n=8 participants at risk
Participants received single dose of Danicamtiv 350mg in either period A, B, C, or D
|
SAD Cohort 1 Placebo
n=8 participants at risk
Participants received single dose of Placebo in either period A, B, or C
|
SAD Cohort 1 Danicamtiv Optional Period D
n=6 participants at risk
Participants received Danicamtiv at either 450mg, 525mg or 550mg in period D
|
SAD Cohort 2 Danicamtiv 400mg
n=4 participants at risk
Participants received split dose of Danicamtiv 400mg
|
SAD Cohort 2 Danicamtiv 500mg
n=4 participants at risk
Participants received split dose of Danicamtiv 500mg
|
SAD Cohort 2 Placebo
n=4 participants at risk
Participants received single dose of Placebo
|
MAD Cohort 1 Danicamtiv 75mg
n=6 participants at risk
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 75mg twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort 1 Placebo
n=2 participants at risk
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Placebo twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort 2 Danicamtiv 50mg
n=9 participants at risk
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 50mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort 2 Placebo
n=3 participants at risk
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Placebo twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort 3 Danicamtiv 75mg
n=9 participants at risk
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 75mg twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort 3 Placebo
n=3 participants at risk
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Placebo twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort 4 Danicamtiv 100mg
n=6 participants at risk
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Danicamtiv 100mg (with food) twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
MAD Cohort 4 Placebo
n=2 participants at risk
Participants received single-blinded placebo twice daily for 2 days. Participants then received double-blinded Placebo twice daily for 7 days, and 2 days of monitoring following the last dose before discharge
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Oedema peripheral
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
11.1%
1/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
11.1%
1/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
33.3%
1/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
11.1%
1/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
25.0%
1/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
11.1%
1/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
33.3%
1/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
|
Cardiac disorders
Cardiac discomfort
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
|
Cardiac disorders
Palpitations
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
11.1%
1/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
11.1%
1/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
25.0%
1/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
11.1%
1/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
22.2%
2/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
33.3%
2/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
|
Eye disorders
Dry eye
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
33.3%
1/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
11.1%
1/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
|
Gastrointestinal disorders
Bowel movement irregularity
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
11.1%
1/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
|
Gastrointestinal disorders
Oral contusion
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
|
General disorders
Application site erosion
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
11.1%
1/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
|
General disorders
Application site irritation
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
|
General disorders
Application site rash
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
11.1%
1/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
|
General disorders
Fatigue
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
22.2%
2/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
|
General disorders
Infusion site discomfort
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
|
General disorders
Infusion site erythema
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
11.1%
1/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
|
General disorders
Vessel puncture site haemorrhage
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
33.3%
2/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
50.0%
1/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
|
Infections and infestations
Urinary tract infection
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
33.3%
1/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
33.3%
1/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
11.1%
1/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
11.1%
1/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
|
Investigations
Blood creatinine increased
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
|
Investigations
Electrocardiogram QRS complex prolonged
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
11.1%
1/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
|
Investigations
Troponin increased
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
11.1%
1/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
11.1%
1/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
33.3%
1/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
33.3%
1/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
11.1%
1/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
25.0%
1/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
11.1%
1/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
|
Nervous system disorders
Headache
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
50.0%
1/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
33.3%
1/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
50.0%
1/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
33.3%
1/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
12.5%
1/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
16.7%
1/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
11.1%
1/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
22.2%
2/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
11.1%
1/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/8 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
25.0%
1/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/4 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/3 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/6 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were monitored from first dose to 30 days post last dose (Up to 2 months). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 20 months)
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please Email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER