Trial Outcomes & Findings for Single Ascending Dose Study of AMG 570 in Healthy Subjects (NCT NCT02618967)
NCT ID: NCT02618967
Last Updated: 2024-05-14
Results Overview
TEAEs were adverse events with an onset after the administration of study treatment. TEAEs were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limited age appropriate instrumental activities of daily life (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolonged hospitalization indicated; disabling; limited self care ADL. Grade 4 Life-threatening consequences; urgent interventions indicated. Serious adverse events (SAEs) were defined as meeting at least 1 of the following criteria: * Results in death (fatal) * Immediately life-threatening * Requires in-patient hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability/incapacity * Is a congenital anomaly/birth defect * Other medically important serious event
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
56 participants
Primary outcome timeframe
Day 1 to Day 105
Results posted on
2024-05-14
Participant Flow
A total of 56 healthy participants were enrolled at 3 research centers in the United States from 28 March 2016 to 06 September 2018.
Participant milestones
| Measure |
AMG 570 - 7 mg
Participants received a single dose 7 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 21 mg
Participants received a single 21 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 70 mg
Participants received a single 70 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 140 mg
Participants received a single 140 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 210 mg
Participants received a single 210 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 420 mg
Participants received a single 420 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 700 mg
Participants received a single 700 mg dose of AMG 570 administered subcutaneously.
|
Placebo
Participants received a single dose of the matching AMG 570 placebo administered subcutaneously.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
14
|
|
Overall Study
Received Treatment
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
14
|
|
Overall Study
COMPLETED
|
5
|
6
|
5
|
6
|
4
|
6
|
6
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
0
|
2
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
AMG 570 - 7 mg
Participants received a single dose 7 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 21 mg
Participants received a single 21 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 70 mg
Participants received a single 70 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 140 mg
Participants received a single 140 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 210 mg
Participants received a single 210 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 420 mg
Participants received a single 420 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 700 mg
Participants received a single 700 mg dose of AMG 570 administered subcutaneously.
|
Placebo
Participants received a single dose of the matching AMG 570 placebo administered subcutaneously.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
2
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Single Ascending Dose Study of AMG 570 in Healthy Subjects
Baseline characteristics by cohort
| Measure |
AMG 570 - 7 mg
n=6 Participants
Participants received a single dose 7 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 21 mg
n=6 Participants
Participants received a single 21 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 70 mg
n=6 Participants
Participants received a single 70 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 140 mg
n=6 Participants
Participants received a single 140 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 210 mg
n=6 Participants
Participants received a single 210 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 420 mg
n=6 Participants
Participants received a single 420 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 700 mg
n=6 Participants
Participants received a single 700 mg dose of AMG 570 administered subcutaneously.
|
Placebo
n=14 Participants
Participants received a single dose of the matching AMG 570 placebo administered subcutaneously.
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
47.7 Years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
45.8 Years
STANDARD_DEVIATION 14.3 • n=7 Participants
|
43.2 Years
STANDARD_DEVIATION 16.7 • n=5 Participants
|
42.0 Years
STANDARD_DEVIATION 9.8 • n=4 Participants
|
39.8 Years
STANDARD_DEVIATION 17.6 • n=21 Participants
|
39.8 Years
STANDARD_DEVIATION 11.4 • n=8 Participants
|
40.0 Years
STANDARD_DEVIATION 17.1 • n=8 Participants
|
44.4 Years
STANDARD_DEVIATION 12.1 • n=24 Participants
|
43.1 Years
STANDARD_DEVIATION 13.1 • n=42 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
9 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
12 Participants
n=24 Participants
|
47 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
12 Participants
n=24 Participants
|
52 Participants
n=42 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
|
0 Participants
n=42 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
|
0 Participants
n=42 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
|
0 Participants
n=42 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
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
15 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
11 Participants
n=24 Participants
|
40 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
1 Participants
n=42 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
|
0 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 105Population: Safety analysis set: all participants who received AMG 570 or placebo.
TEAEs were adverse events with an onset after the administration of study treatment. TEAEs were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limited age appropriate instrumental activities of daily life (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolonged hospitalization indicated; disabling; limited self care ADL. Grade 4 Life-threatening consequences; urgent interventions indicated. Serious adverse events (SAEs) were defined as meeting at least 1 of the following criteria: * Results in death (fatal) * Immediately life-threatening * Requires in-patient hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability/incapacity * Is a congenital anomaly/birth defect * Other medically important serious event
Outcome measures
| Measure |
AMG 570 - 7 mg
n=6 Participants
Participants received a single dose 7 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 21 mg
n=6 Participants
Participants received a single 21 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 70 mg
n=6 Participants
Participants received a single 70 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 140 mg
n=6 Participants
Participants received a single 140 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 210 mg
n=6 Participants
Participants received a single 210 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 420 mg
n=6 Participants
Participants received a single 420 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 700 mg
n=6 Participants
Participants received a single 700 mg dose of AMG 570 administered subcutaneously.
|
Placebo
n=14 Participants
Participants received a single dose of the matching AMG 570 placebo administered subcutaneously.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced One or More Treatment-emergent Adverse Events (TEAEs)
Grade ≥ 3 TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Who Experienced One or More Treatment-emergent Adverse Events (TEAEs)
TEAEs
|
6 Participants
|
5 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
9 Participants
|
|
Number of Participants Who Experienced One or More Treatment-emergent Adverse Events (TEAEs)
Grade ≥ 2 TEAEs
|
4 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants Who Experienced One or More Treatment-emergent Adverse Events (TEAEs)
Grade ≥ 4 TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced One or More Treatment-emergent Adverse Events (TEAEs)
SAEs
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced One or More Treatment-emergent Adverse Events (TEAEs)
Life-threatening TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced One or More Treatment-emergent Adverse Events (TEAEs)
Fatal TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 105Population: Safety analysis set: all participants who received AMG 570 or placebo.
Physical examinations were performed by the investigator, designated physician, or nurse practitioner. A complete physical examination included, at a minimum, assessment of cardiovascular, respiratory, gastrointestinal and neurological systems. A brief physical examination included assessment of the skin, lungs, cardiovascular system, and abdomen (liver and spleen).
Outcome measures
| Measure |
AMG 570 - 7 mg
n=6 Participants
Participants received a single dose 7 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 21 mg
n=6 Participants
Participants received a single 21 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 70 mg
n=6 Participants
Participants received a single 70 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 140 mg
n=6 Participants
Participants received a single 140 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 210 mg
n=6 Participants
Participants received a single 210 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 420 mg
n=6 Participants
Participants received a single 420 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 700 mg
n=6 Participants
Participants received a single 700 mg dose of AMG 570 administered subcutaneously.
|
Placebo
n=14 Participants
Participants received a single dose of the matching AMG 570 placebo administered subcutaneously.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced a Clinically Significant Change in Physical Examinations
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 105Population: Safety analysis set: all participants who received AMG 570 or placebo.
Any changes in blood pressure, body temperature, heart rate, and pulse rate that were deemed as clinically significant by the Investigator were reported.
Outcome measures
| Measure |
AMG 570 - 7 mg
n=6 Participants
Participants received a single dose 7 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 21 mg
n=6 Participants
Participants received a single 21 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 70 mg
n=6 Participants
Participants received a single 70 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 140 mg
n=6 Participants
Participants received a single 140 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 210 mg
n=6 Participants
Participants received a single 210 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 420 mg
n=6 Participants
Participants received a single 420 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 700 mg
n=6 Participants
Participants received a single 700 mg dose of AMG 570 administered subcutaneously.
|
Placebo
n=14 Participants
Participants received a single dose of the matching AMG 570 placebo administered subcutaneously.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced a Clinically Significant Change in Vital Signs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 105Population: Safety analysis set: all participants who received AMG 570 or placebo.
Laboratory safety tests included chemistry, hematology, and urinalysis parameters. Clinically significant laboratory safety tests were any events assessed as CTCAE Grade ≥3 at any post-baseline visit. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolonged hospitalization indicated; disabling; limited self care ADL. Grade 4 Life-threatening consequences; urgent interventions indicated.
Outcome measures
| Measure |
AMG 570 - 7 mg
n=6 Participants
Participants received a single dose 7 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 21 mg
n=6 Participants
Participants received a single 21 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 70 mg
n=6 Participants
Participants received a single 70 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 140 mg
n=6 Participants
Participants received a single 140 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 210 mg
n=6 Participants
Participants received a single 210 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 420 mg
n=6 Participants
Participants received a single 420 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 700 mg
n=6 Participants
Participants received a single 700 mg dose of AMG 570 administered subcutaneously.
|
Placebo
n=14 Participants
Participants received a single dose of the matching AMG 570 placebo administered subcutaneously.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced a Clinically Significant Change in Clinical Laboratory Safety Tests
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 105Population: Safety analysis set: all participants who received AMG 570 or placebo.
Any changes in ECG parameters that were deemed clinically significant by the Investigator were reported.
Outcome measures
| Measure |
AMG 570 - 7 mg
n=6 Participants
Participants received a single dose 7 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 21 mg
n=6 Participants
Participants received a single 21 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 70 mg
n=6 Participants
Participants received a single 70 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 140 mg
n=6 Participants
Participants received a single 140 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 210 mg
n=6 Participants
Participants received a single 210 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 420 mg
n=6 Participants
Participants received a single 420 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 700 mg
n=6 Participants
Participants received a single 700 mg dose of AMG 570 administered subcutaneously.
|
Placebo
n=14 Participants
Participants received a single dose of the matching AMG 570 placebo administered subcutaneously.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced a Clinically Significant Change in Electrocardiograms (ECGs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Pre-dose and 12 hours post-dose on Day 1 and days 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 57, 71 and 105Population: The PK concentration analysis set: all participants who received AMG 570 and had at least one quantifiable PK sample collected.
AMG 570 pharmacokinetic (PK) parameters were estimated using non-compartmental analysis.
Outcome measures
| Measure |
AMG 570 - 7 mg
n=6 Participants
Participants received a single dose 7 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 21 mg
n=6 Participants
Participants received a single 21 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 70 mg
n=6 Participants
Participants received a single 70 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 140 mg
n=6 Participants
Participants received a single 140 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 210 mg
n=6 Participants
Participants received a single 210 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 420 mg
n=6 Participants
Participants received a single 420 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 700 mg
n=6 Participants
Participants received a single 700 mg dose of AMG 570 administered subcutaneously.
|
Placebo
Participants received a single dose of the matching AMG 570 placebo administered subcutaneously.
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Concentration (Cmax) of AMG 570
|
0.08664 µg/mL
Standard Deviation 0.0539
|
0.624 µg/mL
Standard Deviation 0.327
|
4.33 µg/mL
Standard Deviation 3.53
|
6.05 µg/mL
Standard Deviation 3.26
|
17.2 µg/mL
Standard Deviation 3.78
|
33.5 µg/mL
Standard Deviation 15.9
|
58.5 µg/mL
Standard Deviation 19.9
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 12 hours post-dose on Day 1 and days 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 57, 71 and 105Population: The PK concentration analysis set: all participants who received AMG 570 and had at least one quantifiable PK sample collected.
AMG 570 PK parameters were estimated using non-compartmental analysis.
Outcome measures
| Measure |
AMG 570 - 7 mg
n=6 Participants
Participants received a single dose 7 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 21 mg
n=6 Participants
Participants received a single 21 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 70 mg
n=6 Participants
Participants received a single 70 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 140 mg
n=6 Participants
Participants received a single 140 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 210 mg
n=6 Participants
Participants received a single 210 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 420 mg
n=6 Participants
Participants received a single 420 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 700 mg
n=6 Participants
Participants received a single 700 mg dose of AMG 570 administered subcutaneously.
|
Placebo
Participants received a single dose of the matching AMG 570 placebo administered subcutaneously.
|
|---|---|---|---|---|---|---|---|---|
|
Time to Reach Maximum Observed Concentration (Tmax) of AMG 570
|
5.0 days
Interval 2.0 to 5.0
|
3.0 days
Interval 2.0 to 13.0
|
3.0 days
Interval 0.5 to 5.0
|
5.0 days
Interval 5.0 to 5.0
|
5.0 days
Interval 3.0 to 10.0
|
5.0 days
Interval 3.0 to 14.0
|
5.0 days
Interval 3.0 to 10.0
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 12 hours post-dose on Day 1 and days 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 57, 71 and 105Population: The PK concentration analysis set: all participants who received AMG 570 and had at least one quantifiable PK sample collected.
AMG 570 PK parameters were estimated using non-compartmental analysis.
Outcome measures
| Measure |
AMG 570 - 7 mg
n=6 Participants
Participants received a single dose 7 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 21 mg
n=6 Participants
Participants received a single 21 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 70 mg
n=6 Participants
Participants received a single 70 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 140 mg
n=6 Participants
Participants received a single 140 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 210 mg
n=6 Participants
Participants received a single 210 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 420 mg
n=6 Participants
Participants received a single 420 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 700 mg
n=6 Participants
Participants received a single 700 mg dose of AMG 570 administered subcutaneously.
|
Placebo
Participants received a single dose of the matching AMG 570 placebo administered subcutaneously.
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUClast) of AMG 570
|
0.591 day*µg/mL
Standard Deviation 0.321
|
5.12 day*µg/mL
Standard Deviation 2.62
|
43.8 day*µg/mL
Standard Deviation 26.1
|
88.3 day*µg/mL
Standard Deviation 50.1
|
271 day*µg/mL
Standard Deviation 61.3
|
561 day*µg/mL
Standard Deviation 221
|
1660 day*µg/mL
Standard Deviation 759
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 12 hours post-dose on Day 1 and days 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 57, 71 and 105Population: The PK concentration analysis set: all participants who received AMG 570 and had at least one quantifiable PK sample collected.
Outcome measures
| Measure |
AMG 570 - 7 mg
n=3 Participants
Participants received a single dose 7 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 21 mg
n=5 Participants
Participants received a single 21 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 70 mg
n=5 Participants
Participants received a single 70 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 140 mg
n=6 Participants
Participants received a single 140 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 210 mg
n=5 Participants
Participants received a single 210 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 420 mg
n=5 Participants
Participants received a single 420 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 700 mg
n=6 Participants
Participants received a single 700 mg dose of AMG 570 administered subcutaneously.
|
Placebo
Participants received a single dose of the matching AMG 570 placebo administered subcutaneously.
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve Observed From Time Zero to Infinity (AUCinf) of AMG 570
|
0.928 day*µg/mL
Standard Deviation 0.248
|
6.24 day*µg/mL
Standard Deviation 2.76
|
51.1 day*µg/mL
Standard Deviation 21.9
|
88.6 day*µg/mL
Standard Deviation 50.1
|
284 day*µg/mL
Standard Deviation 59.2
|
624 day*µg/mL
Standard Deviation 176
|
1660 day*µg/mL
Standard Deviation 757
|
—
|
SECONDARY outcome
Timeframe: Baseline to Day 105Population: All participants who received AMG 570 and had a negative or no result for binding antibodies at baseline.
The presence of anti-AMG 570 binding antibodies was assessed using a validated assay. The number and percentage of participants who developed binding anti-AMG 570 antibodies at any postbaseline visit are presented.
Outcome measures
| Measure |
AMG 570 - 7 mg
n=6 Participants
Participants received a single dose 7 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 21 mg
n=6 Participants
Participants received a single 21 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 70 mg
n=6 Participants
Participants received a single 70 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 140 mg
n=6 Participants
Participants received a single 140 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 210 mg
n=6 Participants
Participants received a single 210 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 420 mg
n=6 Participants
Participants received a single 420 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 700 mg
n=6 Participants
Participants received a single 700 mg dose of AMG 570 administered subcutaneously.
|
Placebo
Participants received a single dose of the matching AMG 570 placebo administered subcutaneously.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With an Anti-AMG 570 Binding Antibody Positive Postbaseline Result
|
3 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
4 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 8; Day 29; Day 57; and Day 105Population: The pharmacodynamic (PD) analysis set: all participants who had received AMG 570 or placebo and for whom at least one PD parameter had quantifiable baseline sample and a quantifiable PD sample collected at each specified visit.
Peripheral B7RP1 (also known as inducible costimulator ligand \[ICOSL\]) receptor occupancy was calculated from the free ICOSL and total ICOSL measurement from B cells in whole blood.
Outcome measures
| Measure |
AMG 570 - 7 mg
n=6 Participants
Participants received a single dose 7 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 21 mg
n=6 Participants
Participants received a single 21 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 70 mg
n=6 Participants
Participants received a single 70 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 140 mg
n=6 Participants
Participants received a single 140 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 210 mg
n=6 Participants
Participants received a single 210 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 420 mg
n=6 Participants
Participants received a single 420 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 700 mg
n=6 Participants
Participants received a single 700 mg dose of AMG 570 administered subcutaneously.
|
Placebo
n=14 Participants
Participants received a single dose of the matching AMG 570 placebo administered subcutaneously.
|
|---|---|---|---|---|---|---|---|---|
|
Mean Peripheral Blood B7-Related Protein-1 (B7RP-1) Receptor Occupancy on Total B Cells
Day 8
|
13.73 Percentage B7RP-1 receptor occupancy
Standard Deviation 8.81
|
43.76 Percentage B7RP-1 receptor occupancy
Standard Deviation 16.90
|
64.37 Percentage B7RP-1 receptor occupancy
Standard Deviation 14.80
|
80.82 Percentage B7RP-1 receptor occupancy
Standard Deviation 6.60
|
88.87 Percentage B7RP-1 receptor occupancy
Standard Deviation 1.83
|
92.52 Percentage B7RP-1 receptor occupancy
Standard Deviation 1.52
|
95.97 Percentage B7RP-1 receptor occupancy
Standard Deviation 1.85
|
-0.98 Percentage B7RP-1 receptor occupancy
Standard Deviation 13.52
|
|
Mean Peripheral Blood B7-Related Protein-1 (B7RP-1) Receptor Occupancy on Total B Cells
Day 29
|
0.36 Percentage B7RP-1 receptor occupancy
Standard Deviation 19.12
|
20.98 Percentage B7RP-1 receptor occupancy
Standard Deviation 16.60
|
19.96 Percentage B7RP-1 receptor occupancy
Standard Deviation 10.94
|
38.30 Percentage B7RP-1 receptor occupancy
Standard Deviation 9.95
|
72.96 Percentage B7RP-1 receptor occupancy
Standard Deviation 9.21
|
86.64 Percentage B7RP-1 receptor occupancy
Standard Deviation 4.12
|
89.60 Percentage B7RP-1 receptor occupancy
Standard Deviation 9.00
|
0.27 Percentage B7RP-1 receptor occupancy
Standard Deviation 14.86
|
|
Mean Peripheral Blood B7-Related Protein-1 (B7RP-1) Receptor Occupancy on Total B Cells
Day 57
|
3.30 Percentage B7RP-1 receptor occupancy
Standard Deviation 14.27
|
11.28 Percentage B7RP-1 receptor occupancy
Standard Deviation 9.20
|
10.14 Percentage B7RP-1 receptor occupancy
Standard Deviation 8.50
|
6.74 Percentage B7RP-1 receptor occupancy
Standard Deviation 5.47
|
4.55 Percentage B7RP-1 receptor occupancy
Standard Deviation 15.36
|
33.20 Percentage B7RP-1 receptor occupancy
Standard Deviation 20.56
|
65.88 Percentage B7RP-1 receptor occupancy
Standard Deviation 31.67
|
0.85 Percentage B7RP-1 receptor occupancy
Standard Deviation 14.42
|
|
Mean Peripheral Blood B7-Related Protein-1 (B7RP-1) Receptor Occupancy on Total B Cells
Day 105
|
-8.94 Percentage B7RP-1 receptor occupancy
Standard Deviation 26.16
|
4.53 Percentage B7RP-1 receptor occupancy
Standard Deviation 10.31
|
-4.54 Percentage B7RP-1 receptor occupancy
Standard Deviation 8.76
|
1.37 Percentage B7RP-1 receptor occupancy
Standard Deviation 4.45
|
-2.25 Percentage B7RP-1 receptor occupancy
Standard Deviation 8.94
|
-0.08 Percentage B7RP-1 receptor occupancy
Standard Deviation 7.93
|
13.33 Percentage B7RP-1 receptor occupancy
Standard Deviation 17.05
|
-2.90 Percentage B7RP-1 receptor occupancy
Standard Deviation 15.86
|
SECONDARY outcome
Timeframe: Baseline to Day 8; Day 29; Day 57 and Day 105Population: The pharmacodynamic (PD) analysis set: all participants who had received AMG 570 or placebo and for whom at least one PD parameter had quantifiable baseline sample and a quantifiable PD sample collected at each specified visit.
Outcome measures
| Measure |
AMG 570 - 7 mg
n=6 Participants
Participants received a single dose 7 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 21 mg
n=6 Participants
Participants received a single 21 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 70 mg
n=6 Participants
Participants received a single 70 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 140 mg
n=6 Participants
Participants received a single 140 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 210 mg
n=5 Participants
Participants received a single 210 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 420 mg
n=5 Participants
Participants received a single 420 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 700 mg
n=6 Participants
Participants received a single 700 mg dose of AMG 570 administered subcutaneously.
|
Placebo
n=14 Participants
Participants received a single dose of the matching AMG 570 placebo administered subcutaneously.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage Change From Baseline for Cluster of Differentiation (CD)19+ Total B Cells Counts
Percentage change from Baseline at Day 8
|
41.333 Percentage of change
Standard Deviation 73.517
|
53.770 Percentage of change
Standard Deviation 43.216
|
66.531 Percentage of change
Standard Deviation 28.057
|
32.861 Percentage of change
Standard Deviation 21.296
|
57.123 Percentage of change
Standard Deviation 75.399
|
57.478 Percentage of change
Standard Deviation 28.365
|
74.509 Percentage of change
Standard Deviation 70.354
|
2.671 Percentage of change
Standard Deviation 20.898
|
|
Percentage Change From Baseline for Cluster of Differentiation (CD)19+ Total B Cells Counts
Percentage change from Baseline at Day 29
|
-20.284 Percentage of change
Standard Deviation 22.310
|
-8.084 Percentage of change
Standard Deviation 10.212
|
-17.994 Percentage of change
Standard Deviation 15.582
|
-10.047 Percentage of change
Standard Deviation 19.791
|
22.735 Percentage of change
Standard Deviation 51.384
|
26.305 Percentage of change
Standard Deviation 28.795
|
9.637 Percentage of change
Standard Deviation 28.555
|
3.031 Percentage of change
Standard Deviation 23.358
|
|
Percentage Change From Baseline for Cluster of Differentiation (CD)19+ Total B Cells Counts
Percentage change from Baseline at Day 57
|
-2.548 Percentage of change
Standard Deviation 41.873
|
-14.215 Percentage of change
Standard Deviation 14.903
|
-27.494 Percentage of change
Standard Deviation 20.918
|
-37.481 Percentage of change
Standard Deviation 17.440
|
0.386 Percentage of change
Standard Deviation 50.044
|
-8.882 Percentage of change
Standard Deviation 21.936
|
1.212 Percentage of change
Standard Deviation 42.870
|
5.726 Percentage of change
Standard Deviation 28.059
|
|
Percentage Change From Baseline for Cluster of Differentiation (CD)19+ Total B Cells Counts
Percentage change from Baseline at Day 105
|
-15.143 Percentage of change
Standard Deviation 22.117
|
17.010 Percentage of change
Standard Deviation 33.957
|
-16.872 Percentage of change
Standard Deviation 19.064
|
0.841 Percentage of change
Standard Deviation 48.458
|
-8.111 Percentage of change
Standard Deviation 32.077
|
-24.059 Percentage of change
Standard Deviation 25.753
|
-30.413 Percentage of change
Standard Deviation 26.863
|
1.023 Percentage of change
Standard Deviation 13.612
|
SECONDARY outcome
Timeframe: Baseline to Day 8; Day 29; Day 57 and Day 105Population: The PD analysis set: all participants who had received AMG 570 or placebo and for whom at least one PD parameters had quantifiable baseline sample and at quantifiable PD sample collected at each specified visit.
Outcome measures
| Measure |
AMG 570 - 7 mg
n=6 Participants
Participants received a single dose 7 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 21 mg
n=6 Participants
Participants received a single 21 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 70 mg
n=6 Participants
Participants received a single 70 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 140 mg
n=6 Participants
Participants received a single 140 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 210 mg
n=5 Participants
Participants received a single 210 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 420 mg
n=5 Participants
Participants received a single 420 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 700 mg
n=6 Participants
Participants received a single 700 mg dose of AMG 570 administered subcutaneously.
|
Placebo
n=14 Participants
Participants received a single dose of the matching AMG 570 placebo administered subcutaneously.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage Change From Baseline for CD19+ Total B Cells Percentages (%)
Percentage change from Baseline at Day 105
|
-7.738 Percentage of change
Standard Deviation 8.988
|
-1.524 Percentage of change
Standard Deviation 17.352
|
-23.333 Percentage of change
Standard Deviation 14.530
|
-9.947 Percentage of change
Standard Deviation 17.880
|
-15.152 Percentage of change
Standard Deviation 13.165
|
-23.966 Percentage of change
Standard Deviation 13.136
|
-35.474 Percentage of change
Standard Deviation 10.308
|
3.895 Percentage of change
Standard Deviation 16.653
|
|
Percentage Change From Baseline for CD19+ Total B Cells Percentages (%)
Percentage change from Baseline at Day 8
|
56.111 Percentage of change
Standard Deviation 88.264
|
24.057 Percentage of change
Standard Deviation 10.041
|
28.291 Percentage of change
Standard Deviation 16.950
|
20.942 Percentage of change
Standard Deviation 7.799
|
26.538 Percentage of change
Standard Deviation 28.906
|
45.886 Percentage of change
Standard Deviation 25.595
|
23.693 Percentage of change
Standard Deviation 21.414
|
-1.241 Percentage of change
Standard Deviation 12.309
|
|
Percentage Change From Baseline for CD19+ Total B Cells Percentages (%)
Percentage change from Baseline at Day 29
|
-13.714 Percentage of change
Standard Deviation 17.368
|
-13.258 Percentage of change
Standard Deviation 17.292
|
-22.000 Percentage of change
Standard Deviation 9.603
|
-5.778 Percentage of change
Standard Deviation 12.947
|
2.765 Percentage of change
Standard Deviation 28.960
|
7.836 Percentage of change
Standard Deviation 20.250
|
4.063 Percentage of change
Standard Deviation 15.629
|
-0.582 Percentage of change
Standard Deviation 17.259
|
|
Percentage Change From Baseline for CD19+ Total B Cells Percentages (%)
Percentage change from Baseline at Day 57
|
29.484 Percentage of change
Standard Deviation 84.641
|
-21.751 Percentage of change
Standard Deviation 11.893
|
-26.000 Percentage of change
Standard Deviation 20.346
|
-36.293 Percentage of change
Standard Deviation 18.635
|
-16.667 Percentage of change
Standard Deviation 35.355
|
-10.467 Percentage of change
Standard Deviation 4.058
|
-7.500 Percentage of change
Standard Deviation 19.632
|
0.167 Percentage of change
Standard Deviation 16.092
|
Adverse Events
AMG 570 - 7 mg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
AMG 570 - 21 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
AMG 570 - 70 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
AMG 570 - 140 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
AMG 570 - 210 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
AMG 570 - 420 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
AMG 570 - 700 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AMG 570 - 7 mg
n=6 participants at risk
Participants received a single dose 7 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 21 mg
n=6 participants at risk
Participants received a single 21 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 70 mg
n=6 participants at risk
Participants received a single 70 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 140 mg
n=6 participants at risk
Participants received a single 140 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 210 mg
n=6 participants at risk
Participants received a single 210 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 420 mg
n=6 participants at risk
Participants received a single 420 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 700 mg
n=6 participants at risk
Participants received 700 mg dose of AMG 570 administered as single dose subcutaneous in healthy volunteers.
|
Placebo
n=14 participants at risk
Participants received a single dose of the matching AMG 570 placebo administered subcutaneously.
|
|---|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Injury
|
16.7%
1/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
AMG 570 - 7 mg
n=6 participants at risk
Participants received a single dose 7 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 21 mg
n=6 participants at risk
Participants received a single 21 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 70 mg
n=6 participants at risk
Participants received a single 70 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 140 mg
n=6 participants at risk
Participants received a single 140 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 210 mg
n=6 participants at risk
Participants received a single 210 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 420 mg
n=6 participants at risk
Participants received a single 420 mg dose of AMG 570 administered subcutaneously.
|
AMG 570 - 700 mg
n=6 participants at risk
Participants received 700 mg dose of AMG 570 administered as single dose subcutaneous in healthy volunteers.
|
Placebo
n=14 participants at risk
Participants received a single dose of the matching AMG 570 placebo administered subcutaneously.
|
|---|---|---|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Ear pain
|
16.7%
1/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
1/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
16.7%
1/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
1/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Application site erythema
|
16.7%
1/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
7.1%
1/14 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Injection site erythema
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
2/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
7.1%
1/14 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Injection site pain
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Injection site pruritus
|
16.7%
1/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Injection site warmth
|
16.7%
1/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Malaise
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Vessel puncture site bruise
|
33.3%
2/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Vessel puncture site haemorrhage
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Pharyngitis
|
16.7%
1/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
33.3%
2/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
2/14 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Vaginal infection
|
16.7%
1/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
7.1%
1/14 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Exposure to toxic agent
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
7.1%
1/14 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
16.7%
1/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
7.1%
1/14 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
7.1%
1/14 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
7.1%
1/14 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
7.1%
1/14 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Blood pressure increased
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Blood pressure systolic increased
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
16.7%
1/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
16.7%
1/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
1/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
7.1%
1/14 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
2/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
7.1%
1/14 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
7.1%
1/14 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
16.7%
1/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
16.7%
1/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
7.1%
1/14 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
16.7%
1/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Papule
|
16.7%
1/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
1/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
16.7%
1/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/14 • Up to 105 days
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER