Trial Outcomes & Findings for Safety, Tolerability, and Pharmacokinetics of Clesrovimab (MK-1654) in Infants (MK-1654-002) (NCT NCT03524118)
NCT ID: NCT03524118
Last Updated: 2025-01-14
Results Overview
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection site AEs were monitored from Day 1 to Day 5.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
183 participants
Primary outcome timeframe
Up to Day 5
Results posted on
2025-01-14
Participant Flow
183 participants were randomized and 181 were dosed and included in the All Participants as Treated (APaT) population. Two participants who were randomized to the MK-1654 20 mg dose group actually received MK-1654 50 mg and were included in the MK-1654 50 mg group for safety, pharmacokinetic (PK) and immunogenicity analyses.
Participants enrolled in panels D and E prior to protocol amendment 04 who chose not to participate in the modified schedule followed the D1 and E1 schedule of activities. Participants enrolled in panels D and E prior to protocol amendment 04 who chose to participate in the modified schedule followed the D2 and E2 schedule of activities.
Participant milestones
| Measure |
Panel A: Preterm Clesrovimab 20mg
Pre-term infants received clesrovimab 20mg via intramuscular (IM) injection and were followed for up to 365 days.
|
Panel B: Pre-term Clesrovimab 50mg
Pre-term infants received clesrovimab 50mg via IM injection and were followed for up to 365 days.
|
Panel C: Pre-term Clesrovimab 75mg
Pre-term infants received clesrovimab 75mg via IM injection and were followed for up to 365 days.
|
Panel D1 and D2: Pre-term Clesrovimab 100mg
Pre-term infants in Panel D1 and D2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.
|
Panel E1 and E2: Full-term Clesrovimab 100mg
Full-term infants in Panel E1 and E2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.
|
Placebo
Pre-term and Full-term infants received placebo via IM injection.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
31
|
41
|
32
|
33
|
38
|
|
Overall Study
Treated
|
8
|
31
|
40
|
32
|
32
|
38
|
|
Overall Study
Safety Analysis Population
|
6
|
33
|
40
|
32
|
32
|
38
|
|
Overall Study
COMPLETED
|
8
|
29
|
40
|
31
|
26
|
37
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
1
|
1
|
7
|
1
|
Reasons for withdrawal
| Measure |
Panel A: Preterm Clesrovimab 20mg
Pre-term infants received clesrovimab 20mg via intramuscular (IM) injection and were followed for up to 365 days.
|
Panel B: Pre-term Clesrovimab 50mg
Pre-term infants received clesrovimab 50mg via IM injection and were followed for up to 365 days.
|
Panel C: Pre-term Clesrovimab 75mg
Pre-term infants received clesrovimab 75mg via IM injection and were followed for up to 365 days.
|
Panel D1 and D2: Pre-term Clesrovimab 100mg
Pre-term infants in Panel D1 and D2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.
|
Panel E1 and E2: Full-term Clesrovimab 100mg
Full-term infants in Panel E1 and E2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.
|
Placebo
Pre-term and Full-term infants received placebo via IM injection.
|
|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Other
|
0
|
1
|
0
|
0
|
1
|
1
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Parent/Guardian
|
0
|
1
|
0
|
1
|
3
|
0
|
Baseline Characteristics
Safety, Tolerability, and Pharmacokinetics of Clesrovimab (MK-1654) in Infants (MK-1654-002)
Baseline characteristics by cohort
| Measure |
Panel A: Preterm Clesrovimab 20mg
n=8 Participants
Pre-term infants received clesrovimab 20mg via intramuscular (IM) injection and were followed for up to 365 days.
|
Panel B: Pre-term Clesrovimab 50mg
n=31 Participants
Pre-term infants received clesrovimab 50mg via IM injection and were followed for up to 365 days.
|
Panel C: Pre-term Clesrovimab 75mg
n=41 Participants
Pre-term infants received clesrovimab 75mg via IM injection and were followed for up to 365 days.
|
Panel D1 and D2: Pre-term Clesrovimab 100mg
n=32 Participants
Pre-term infants received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days.
|
Panel E1 and E2: Full-term Clesrovimab 100mg
n=33 Participants
Full-term infants received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days.
|
Placebo
n=38 Participants
Pre-term and Full-term infants received placebo via IM injection.
|
Total
n=183 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
68.0 days
n=5 Participants
|
109.0 days
n=7 Participants
|
94.0 days
n=5 Participants
|
139.5 days
n=4 Participants
|
164.0 days
n=21 Participants
|
128.0 days
n=8 Participants
|
126.0 days
n=8 Participants
|
|
Age, Customized
In utero
|
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
|
|
Age, Customized
Preterm newborn infants (gestational age < 37 wks)
|
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
|
|
Age, Customized
Newborns (0-27 days)
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
|
Age, Customized
Infants and toddlers (28 days-23 months)
|
8 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
36 Participants
n=8 Participants
|
173 Participants
n=8 Participants
|
|
Age, Customized
Children (2-11 years)
|
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
|
|
Age, Customized
Adolescents (12-17 years)
|
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
|
|
Age, Customized
Adults (18-64 years)
|
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
|
|
Age, Customized
From 65-84 years
|
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
|
|
Age, Customized
85 years and over
|
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
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
19 Participants
n=8 Participants
|
90 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
19 Participants
n=8 Participants
|
93 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
18 Participants
n=8 Participants
|
79 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
20 Participants
n=8 Participants
|
104 Participants
n=8 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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
6 Participants
n=8 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
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
60 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
71 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
36 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Up to Day 5Population: Safety analysis population consisted of all participants who received at least one dose of study treatment. Two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection site AEs were monitored from Day 1 to Day 5.
Outcome measures
| Measure |
Panel A: Preterm Clesrovimab 20mg
n=6 Participants
Pre-term infants received clesrovimab 20mg via intramuscular (IM) injection and were followed for up to 365 days.
|
Panel B: Pre-term Clesrovimab 50mg
n=33 Participants
Pre-term infants received clesrovimab 50mg via IM injection and were followed for up to 365 days.
|
Panel C: Pre-term Clesrovimab 75mg
n=40 Participants
Pre-term infants received clesrovimab 75mg via IM injection and were followed for up to 365 days.
|
Panel D1 and D2: Pre-term Clesrovimab 100mg
n=32 Participants
Pre-term infants in Panel D1 and D2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.
|
Panel E1 and E2: Full-term Clesrovimab 100mg
n=32 Participants
Full-term infants in Panel E1 and E2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.
|
Placebo
n=38 Participants
Pre-term and Full-term infants received placebo via IM injection.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Who Experienced At Least One Solicited Injection Site Adverse Event (AE)
without solicited injection site adverse events
|
3 Participants
|
30 Participants
|
37 Participants
|
30 Participants
|
30 Participants
|
36 Participants
|
|
Percentage of Participants Who Experienced At Least One Solicited Injection Site Adverse Event (AE)
with solicited injection site adverse events
|
3 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Up to Day 5Population: Safety analysis population consisted of all participants who received at least one dose of study treatment. Two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs were monitored from Day 1 to Day 5.
Outcome measures
| Measure |
Panel A: Preterm Clesrovimab 20mg
n=6 Participants
Pre-term infants received clesrovimab 20mg via intramuscular (IM) injection and were followed for up to 365 days.
|
Panel B: Pre-term Clesrovimab 50mg
n=33 Participants
Pre-term infants received clesrovimab 50mg via IM injection and were followed for up to 365 days.
|
Panel C: Pre-term Clesrovimab 75mg
n=40 Participants
Pre-term infants received clesrovimab 75mg via IM injection and were followed for up to 365 days.
|
Panel D1 and D2: Pre-term Clesrovimab 100mg
n=32 Participants
Pre-term infants in Panel D1 and D2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.
|
Panel E1 and E2: Full-term Clesrovimab 100mg
n=32 Participants
Full-term infants in Panel E1 and E2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.
|
Placebo
n=38 Participants
Pre-term and Full-term infants received placebo via IM injection.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Who Experienced At Least One Solicited Systemic Adverse Event (AE)
with solicited systemic adverse events
|
2 Participants
|
8 Participants
|
9 Participants
|
2 Participants
|
3 Participants
|
9 Participants
|
|
Percentage of Participants Who Experienced At Least One Solicited Systemic Adverse Event (AE)
without solicited systemic adverse events
|
4 Participants
|
25 Participants
|
31 Participants
|
30 Participants
|
29 Participants
|
29 Participants
|
PRIMARY outcome
Timeframe: Up to Day 545Population: Safety analysis population consisted of all participants who received at least one dose of study treatment. Two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
An SAE is any untoward medical occurrence that, at any dose, results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant injury/incapacity; is a congenital anomaly/birth defect; or is an other important medical event.
Outcome measures
| Measure |
Panel A: Preterm Clesrovimab 20mg
n=6 Participants
Pre-term infants received clesrovimab 20mg via intramuscular (IM) injection and were followed for up to 365 days.
|
Panel B: Pre-term Clesrovimab 50mg
n=33 Participants
Pre-term infants received clesrovimab 50mg via IM injection and were followed for up to 365 days.
|
Panel C: Pre-term Clesrovimab 75mg
n=40 Participants
Pre-term infants received clesrovimab 75mg via IM injection and were followed for up to 365 days.
|
Panel D1 and D2: Pre-term Clesrovimab 100mg
n=32 Participants
Pre-term infants in Panel D1 and D2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.
|
Panel E1 and E2: Full-term Clesrovimab 100mg
n=32 Participants
Full-term infants in Panel E1 and E2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.
|
Placebo
n=38 Participants
Pre-term and Full-term infants received placebo via IM injection.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Who Experienced At Least One Serious Adverse Event (SAE)
with serious adverse events (SAE)
|
1 Participants
|
4 Participants
|
1 Participants
|
3 Participants
|
6 Participants
|
6 Participants
|
|
Percentage of Participants Who Experienced At Least One Serious Adverse Event (SAE)
without SAE
|
5 Participants
|
29 Participants
|
39 Participants
|
29 Participants
|
26 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: At designated time points (up to 1 year post-dose)Population: All randomized participants who received at least one dose of study treatment, with exclusions for important protocol deviations that may have substantially affected the results and with data available for this outcome measure. Two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified PK analysis population.
AUC0-∞ is a measure of the extrapolated mean concentration in serum from dosing to infinity.
Outcome measures
| Measure |
Panel A: Preterm Clesrovimab 20mg
n=5 Participants
Pre-term infants received clesrovimab 20mg via intramuscular (IM) injection and were followed for up to 365 days.
|
Panel B: Pre-term Clesrovimab 50mg
n=33 Participants
Pre-term infants received clesrovimab 50mg via IM injection and were followed for up to 365 days.
|
Panel C: Pre-term Clesrovimab 75mg
n=40 Participants
Pre-term infants received clesrovimab 75mg via IM injection and were followed for up to 365 days.
|
Panel D1 and D2: Pre-term Clesrovimab 100mg
n=32 Participants
Pre-term infants in Panel D1 and D2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.
|
Panel E1 and E2: Full-term Clesrovimab 100mg
n=31 Participants
Full-term infants in Panel E1 and E2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.
|
Placebo
Pre-term and Full-term infants received placebo via IM injection.
|
|---|---|---|---|---|---|---|
|
Area Under the Serum-Concentration Time Curve From Zero to Infinity (AUC0-∞)
|
1560 day*μg/mL
Geometric Coefficient of Variation 43.5
|
3520 day*μg/mL
Geometric Coefficient of Variation 22.8
|
5510 day*μg/mL
Geometric Coefficient of Variation 22.4
|
6790 day*μg/mL
Geometric Coefficient of Variation 25.4
|
5690 day*μg/mL
Geometric Coefficient of Variation 15.9
|
—
|
SECONDARY outcome
Timeframe: At designated time points (up to 1 year post-dose)Population: All randomized participants who received at least one dose of study treatment, with exclusions for important protocol deviations that may have substantially affected the results and with data available for this outcome measure. Two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified PK analysis population.
Cmax is the highest observed serum drug concentration.
Outcome measures
| Measure |
Panel A: Preterm Clesrovimab 20mg
n=5 Participants
Pre-term infants received clesrovimab 20mg via intramuscular (IM) injection and were followed for up to 365 days.
|
Panel B: Pre-term Clesrovimab 50mg
n=33 Participants
Pre-term infants received clesrovimab 50mg via IM injection and were followed for up to 365 days.
|
Panel C: Pre-term Clesrovimab 75mg
n=40 Participants
Pre-term infants received clesrovimab 75mg via IM injection and were followed for up to 365 days.
|
Panel D1 and D2: Pre-term Clesrovimab 100mg
n=32 Participants
Pre-term infants in Panel D1 and D2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.
|
Panel E1 and E2: Full-term Clesrovimab 100mg
n=31 Participants
Full-term infants in Panel E1 and E2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.
|
Placebo
Pre-term and Full-term infants received placebo via IM injection.
|
|---|---|---|---|---|---|---|
|
Maximum Serum Concentration (Cmax) of Clesrovimab
|
26.3 μg/mL
Geometric Coefficient of Variation 19.3
|
61.7 μg/mL
Geometric Coefficient of Variation 21.8
|
94.5 μg/mL
Geometric Coefficient of Variation 20.5
|
117 μg/mL
Geometric Coefficient of Variation 23.5
|
99.9 μg/mL
Geometric Coefficient of Variation 13.7
|
—
|
SECONDARY outcome
Timeframe: At designated time points (up to 1 year post-dose)Population: All randomized participants who received at least one dose of study treatment, with exclusions for important protocol deviations that may have substantially affected the results and with data available for this outcome measure. Two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified PK analysis population.
Tmax is the time taken to reach the maximum observed plasma (Cmax) concentration of Clesrovimab.
Outcome measures
| Measure |
Panel A: Preterm Clesrovimab 20mg
n=5 Participants
Pre-term infants received clesrovimab 20mg via intramuscular (IM) injection and were followed for up to 365 days.
|
Panel B: Pre-term Clesrovimab 50mg
n=33 Participants
Pre-term infants received clesrovimab 50mg via IM injection and were followed for up to 365 days.
|
Panel C: Pre-term Clesrovimab 75mg
n=40 Participants
Pre-term infants received clesrovimab 75mg via IM injection and were followed for up to 365 days.
|
Panel D1 and D2: Pre-term Clesrovimab 100mg
n=32 Participants
Pre-term infants in Panel D1 and D2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.
|
Panel E1 and E2: Full-term Clesrovimab 100mg
n=31 Participants
Full-term infants in Panel E1 and E2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.
|
Placebo
Pre-term and Full-term infants received placebo via IM injection.
|
|---|---|---|---|---|---|---|
|
Time to Maximum Serum Concentration (Tmax) of Clesrovimab
|
4.0 day
Interval 3.8 to 4.6
|
4.20 day
Interval 3.7 to 5.3
|
4.20 day
Interval 3.0 to 5.8
|
4.10 day
Interval 3.7 to 6.0
|
4.10 day
Interval 3.7 to 4.9
|
—
|
SECONDARY outcome
Timeframe: At designated time points (up to 1 year post-dose)Population: All randomized participants who received at least one dose of study treatment, with exclusions for important protocol deviations that may have substantially affected the results and with data available for this outcome measure. Two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified PK analysis population.
t1/2 is the time required for 50% of drug to be cleared from serum.
Outcome measures
| Measure |
Panel A: Preterm Clesrovimab 20mg
n=5 Participants
Pre-term infants received clesrovimab 20mg via intramuscular (IM) injection and were followed for up to 365 days.
|
Panel B: Pre-term Clesrovimab 50mg
n=33 Participants
Pre-term infants received clesrovimab 50mg via IM injection and were followed for up to 365 days.
|
Panel C: Pre-term Clesrovimab 75mg
n=40 Participants
Pre-term infants received clesrovimab 75mg via IM injection and were followed for up to 365 days.
|
Panel D1 and D2: Pre-term Clesrovimab 100mg
n=32 Participants
Pre-term infants in Panel D1 and D2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.
|
Panel E1 and E2: Full-term Clesrovimab 100mg
n=31 Participants
Full-term infants in Panel E1 and E2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.
|
Placebo
Pre-term and Full-term infants received placebo via IM injection.
|
|---|---|---|---|---|---|---|
|
Apparent Terminal Half-life (t1/2) of Clesrovimab
|
48.8 day
Geometric Coefficient of Variation 34.6
|
44.6 day
Geometric Coefficient of Variation 10.9
|
46.1 day
Geometric Coefficient of Variation 15.1
|
45.2 day
Geometric Coefficient of Variation 13.7
|
43.0 day
Geometric Coefficient of Variation 9.72
|
—
|
SECONDARY outcome
Timeframe: Day 7Population: All randomized participants who received at least one dose of study treatment, with exclusions for important protocol deviations that may have substantially affected the results and with data available for this outcome measure. Two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified PK analysis population.
Serum concentration of clesrovimab was measured on Day 7.
Outcome measures
| Measure |
Panel A: Preterm Clesrovimab 20mg
n=5 Participants
Pre-term infants received clesrovimab 20mg via intramuscular (IM) injection and were followed for up to 365 days.
|
Panel B: Pre-term Clesrovimab 50mg
n=33 Participants
Pre-term infants received clesrovimab 50mg via IM injection and were followed for up to 365 days.
|
Panel C: Pre-term Clesrovimab 75mg
n=40 Participants
Pre-term infants received clesrovimab 75mg via IM injection and were followed for up to 365 days.
|
Panel D1 and D2: Pre-term Clesrovimab 100mg
n=32 Participants
Pre-term infants in Panel D1 and D2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.
|
Panel E1 and E2: Full-term Clesrovimab 100mg
n=31 Participants
Full-term infants in Panel E1 and E2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.
|
Placebo
Pre-term and Full-term infants received placebo via IM injection.
|
|---|---|---|---|---|---|---|
|
Serum Concentration of Clesrovimab on Day 7 (C7days)
|
24.4 μg/mL
Geometric Coefficient of Variation 20.4
|
57.8 μg/mL
Geometric Coefficient of Variation 21.6
|
88.1 μg/mL
Geometric Coefficient of Variation 20.4
|
109 μg/mL
Geometric Coefficient of Variation 23.0
|
92.8 μg/mL
Geometric Coefficient of Variation 13.3
|
—
|
SECONDARY outcome
Timeframe: Day 14Population: All randomized participants who received at least one dose of study treatment, with exclusions for important protocol deviations that may have substantially affected the results and with data available for this outcome measure. Two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified PK analysis population.
Serum concentration of clesrovimab was measured on Day 14.
Outcome measures
| Measure |
Panel A: Preterm Clesrovimab 20mg
n=5 Participants
Pre-term infants received clesrovimab 20mg via intramuscular (IM) injection and were followed for up to 365 days.
|
Panel B: Pre-term Clesrovimab 50mg
n=33 Participants
Pre-term infants received clesrovimab 50mg via IM injection and were followed for up to 365 days.
|
Panel C: Pre-term Clesrovimab 75mg
n=40 Participants
Pre-term infants received clesrovimab 75mg via IM injection and were followed for up to 365 days.
|
Panel D1 and D2: Pre-term Clesrovimab 100mg
n=32 Participants
Pre-term infants in Panel D1 and D2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.
|
Panel E1 and E2: Full-term Clesrovimab 100mg
n=31 Participants
Full-term infants in Panel E1 and E2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.
|
Placebo
Pre-term and Full-term infants received placebo via IM injection.
|
|---|---|---|---|---|---|---|
|
Serum Concentration of Clesrovimab on Day 14 (C14days)
|
19.4 μg/mL
Geometric Coefficient of Variation 22.1
|
46.8 μg/mL
Geometric Coefficient of Variation 20.6
|
71.1 μg/mL
Geometric Coefficient of Variation 19.7
|
88.6 μg/mL
Geometric Coefficient of Variation 21.8
|
75.4 μg/mL
Geometric Coefficient of Variation 12.9
|
—
|
SECONDARY outcome
Timeframe: Day 90Population: All randomized participants who received at least one dose of study treatment, with exclusions for important protocol deviations that may have substantially affected the results and with data available for this outcome measure. Two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified PK analysis population.
Serum concentration of clesrovimab was measured on Day 90.
Outcome measures
| Measure |
Panel A: Preterm Clesrovimab 20mg
n=5 Participants
Pre-term infants received clesrovimab 20mg via intramuscular (IM) injection and were followed for up to 365 days.
|
Panel B: Pre-term Clesrovimab 50mg
n=33 Participants
Pre-term infants received clesrovimab 50mg via IM injection and were followed for up to 365 days.
|
Panel C: Pre-term Clesrovimab 75mg
n=40 Participants
Pre-term infants received clesrovimab 75mg via IM injection and were followed for up to 365 days.
|
Panel D1 and D2: Pre-term Clesrovimab 100mg
n=32 Participants
Pre-term infants in Panel D1 and D2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.
|
Panel E1 and E2: Full-term Clesrovimab 100mg
n=31 Participants
Full-term infants in Panel E1 and E2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.
|
Placebo
Pre-term and Full-term infants received placebo via IM injection.
|
|---|---|---|---|---|---|---|
|
Serum Concentration of Clesrovimab on Day 90 (C90days)
|
5.60 μg/mL
Geometric Coefficient of Variation 49.5
|
13.0 μg/mL
Geometric Coefficient of Variation 25.4
|
20.4 μg/mL
Geometric Coefficient of Variation 25.8
|
25.2 μg/mL
Geometric Coefficient of Variation 28.6
|
21.1 μg/mL
Geometric Coefficient of Variation 18.8
|
—
|
SECONDARY outcome
Timeframe: Day 150Population: All randomized participants who received at least one dose of study treatment, with exclusions for important protocol deviations that may have substantially affected the results and with data available for this outcome measure. Two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified PK analysis population.
Serum concentration of clesrovimab was measured on Day 150.
Outcome measures
| Measure |
Panel A: Preterm Clesrovimab 20mg
n=5 Participants
Pre-term infants received clesrovimab 20mg via intramuscular (IM) injection and were followed for up to 365 days.
|
Panel B: Pre-term Clesrovimab 50mg
n=33 Participants
Pre-term infants received clesrovimab 50mg via IM injection and were followed for up to 365 days.
|
Panel C: Pre-term Clesrovimab 75mg
n=40 Participants
Pre-term infants received clesrovimab 75mg via IM injection and were followed for up to 365 days.
|
Panel D1 and D2: Pre-term Clesrovimab 100mg
n=32 Participants
Pre-term infants in Panel D1 and D2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.
|
Panel E1 and E2: Full-term Clesrovimab 100mg
n=31 Participants
Full-term infants in Panel E1 and E2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.
|
Placebo
Pre-term and Full-term infants received placebo via IM injection.
|
|---|---|---|---|---|---|---|
|
Serum Concentration of Clesrovimab on Day 150 (C150days)
|
2.24 μg/mL
Geometric Coefficient of Variation 80.6
|
4.98 μg/mL
Geometric Coefficient of Variation 34.2
|
8.05 μg/mL
Geometric Coefficient of Variation 37.7
|
9.70 μg/mL
Geometric Coefficient of Variation 40.2
|
7.96 μg/mL
Geometric Coefficient of Variation 26.7
|
—
|
SECONDARY outcome
Timeframe: Day 365Population: All randomized participants who received at least one dose of study treatment, with exclusions for important protocol deviations that may have substantially affected the results and with data available for this outcome measure. Two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified PK analysis population.
Serum concentration of clesrovimab was measured on Day 365.
Outcome measures
| Measure |
Panel A: Preterm Clesrovimab 20mg
n=5 Participants
Pre-term infants received clesrovimab 20mg via intramuscular (IM) injection and were followed for up to 365 days.
|
Panel B: Pre-term Clesrovimab 50mg
n=33 Participants
Pre-term infants received clesrovimab 50mg via IM injection and were followed for up to 365 days.
|
Panel C: Pre-term Clesrovimab 75mg
n=40 Participants
Pre-term infants received clesrovimab 75mg via IM injection and were followed for up to 365 days.
|
Panel D1 and D2: Pre-term Clesrovimab 100mg
n=32 Participants
Pre-term infants in Panel D1 and D2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.
|
Panel E1 and E2: Full-term Clesrovimab 100mg
n=31 Participants
Full-term infants in Panel E1 and E2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.
|
Placebo
Pre-term and Full-term infants received placebo via IM injection.
|
|---|---|---|---|---|---|---|
|
Serum Concentration of Clesrovimab on Day 365 (C365days)
|
0.0953 μg/mL
Geometric Coefficient of Variation 362
|
0.177 μg/mL
Geometric Coefficient of Variation 79.4
|
0.313 μg/mL
Geometric Coefficient of Variation 107
|
0.355 μg/mL
Geometric Coefficient of Variation 104
|
0.248 μg/mL
Geometric Coefficient of Variation 63.1
|
—
|
SECONDARY outcome
Timeframe: Days 14, 90, 150, 365 and 545Population: All randomized participants who received at least one dose of study treatment and were evaluable with at least one ADA result after treatment with MK-1654. Two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50 mg and were included in the MK-1654 50 mg group for the protocol specified immunogenicity analysis population.
ADA was assessed at 2 or 3 of the following timepoints for each participant: Days 14, 90, 150, 365 and 545. ADA status for each participant was determined across the timepoints assessed. The definitions of the categories are as follows: (1) ADA Negative: participants whose ADA results were negative at all timepoints measured; (2) Non-treatment emergent positive: participants whose ADA result was positive only at baseline or if postdose titer increased by less than 2-fold relative to the baseline titer; (3) Positive response to MK-1654: participants whose ADA result was negative at baseline and positive at one or more postdose timepoints or participants whose ADA result was positive at baseline and postdose titer increased by greater than or equal to 2-fold relative to the baseline titer.
Outcome measures
| Measure |
Panel A: Preterm Clesrovimab 20mg
n=6 Participants
Pre-term infants received clesrovimab 20mg via intramuscular (IM) injection and were followed for up to 365 days.
|
Panel B: Pre-term Clesrovimab 50mg
n=32 Participants
Pre-term infants received clesrovimab 50mg via IM injection and were followed for up to 365 days.
|
Panel C: Pre-term Clesrovimab 75mg
n=39 Participants
Pre-term infants received clesrovimab 75mg via IM injection and were followed for up to 365 days.
|
Panel D1 and D2: Pre-term Clesrovimab 100mg
n=32 Participants
Pre-term infants in Panel D1 and D2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.
|
Panel E1 and E2: Full-term Clesrovimab 100mg
n=30 Participants
Full-term infants in Panel E1 and E2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.
|
Placebo
Pre-term and Full-term infants received placebo via IM injection.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Positive Titer of Anti-Drug Antibodies (ADAs) for Clesrovimab: Panels A, B, C, D1, D2, E1, and E2
ADA Negative status
|
4 Participants
|
23 Participants
|
35 Participants
|
15 Participants
|
9 Participants
|
—
|
|
Number of Participants With Positive Titer of Anti-Drug Antibodies (ADAs) for Clesrovimab: Panels A, B, C, D1, D2, E1, and E2
Non-treatment emergent positive
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Number of Participants With Positive Titer of Anti-Drug Antibodies (ADAs) for Clesrovimab: Panels A, B, C, D1, D2, E1, and E2
ADA Positive response to MK-1654
|
2 Participants
|
9 Participants
|
4 Participants
|
16 Participants
|
20 Participants
|
—
|
|
Number of Participants With Positive Titer of Anti-Drug Antibodies (ADAs) for Clesrovimab: Panels A, B, C, D1, D2, E1, and E2
Maximum Postdose Titer of 189 to < 1077.5 of ADA
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
7 Participants
|
—
|
|
Number of Participants With Positive Titer of Anti-Drug Antibodies (ADAs) for Clesrovimab: Panels A, B, C, D1, D2, E1, and E2
Maximum Postdose Titer of 1077.5 to < 9285 of ADA
|
0 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
7 Participants
|
—
|
|
Number of Participants With Positive Titer of Anti-Drug Antibodies (ADAs) for Clesrovimab: Panels A, B, C, D1, D2, E1, and E2
Maximum Postdose Titer of 9285 to 160000 of ADA
|
2 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
4 Participants
|
—
|
|
Number of Participants With Positive Titer of Anti-Drug Antibodies (ADAs) for Clesrovimab: Panels A, B, C, D1, D2, E1, and E2
Maximum Postdose Titer of 20 to < 189 of ADA
|
0 Participants
|
6 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
—
|
Adverse Events
MK-1654 20 mg in Pre-term Infants
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
MK-1654 50 mg in Pre-term Infants
Serious events: 4 serious events
Other events: 29 other events
Deaths: 0 deaths
MK-1654 75 mg in Pre-term Infants
Serious events: 1 serious events
Other events: 29 other events
Deaths: 0 deaths
MK-1654 100 mg Pre-Term Infants
Serious events: 3 serious events
Other events: 26 other events
Deaths: 0 deaths
MK-1654 100 mg Full-Term Infants
Serious events: 6 serious events
Other events: 29 other events
Deaths: 0 deaths
Placebo
Serious events: 6 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MK-1654 20 mg in Pre-term Infants
n=6 participants at risk
Pre-term infants received clesrovimab 20mg via intramuscular (IM) injection and were followed for up to 365 days.
|
MK-1654 50 mg in Pre-term Infants
n=33 participants at risk
Pre-term infants received clesrovimab 50mg via IM injection and were followed for up to 365 days.
|
MK-1654 75 mg in Pre-term Infants
n=40 participants at risk
Pre-term infants received clesrovimab 75mg via IM injection and were followed for up to 365 days.
|
MK-1654 100 mg Pre-Term Infants
n=32 participants at risk
Pre-term infants in Panel D1 and D2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.
|
MK-1654 100 mg Full-Term Infants
n=32 participants at risk
Full-term infants in Panel E1 and E2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.
|
Placebo
n=38 participants at risk
Pre-term and Full-term infants received placebo via IM injection.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/6 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/33 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/40 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/32 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/32 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
2.6%
1/38 • Number of events 1 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
|
Hepatobiliary disorders
Biliary cyst
|
0.00%
0/6 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/33 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/40 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/32 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
3.1%
1/32 • Number of events 1 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/38 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
|
Infections and infestations
Bronchiolitis
|
16.7%
1/6 • Number of events 1 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/33 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/40 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/32 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/32 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
5.3%
2/38 • Number of events 2 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
|
Infections and infestations
COVID-19
|
0.00%
0/6 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/33 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/40 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
3.1%
1/32 • Number of events 1 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/32 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/38 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/6 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/33 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/40 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
3.1%
1/32 • Number of events 1 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/32 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/38 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
|
Infections and infestations
Croup infectious
|
0.00%
0/6 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/33 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/40 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/32 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
3.1%
1/32 • Number of events 1 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/38 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/6 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
3.0%
1/33 • Number of events 1 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/40 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/32 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
3.1%
1/32 • Number of events 1 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/38 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
|
Infections and infestations
Pneumonia
|
16.7%
1/6 • Number of events 1 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/33 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/40 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/32 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
6.2%
2/32 • Number of events 2 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/38 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.00%
0/6 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
3.0%
1/33 • Number of events 1 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/40 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/32 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/32 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
7.9%
3/38 • Number of events 3 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/6 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/33 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/40 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
3.1%
1/32 • Number of events 1 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
3.1%
1/32 • Number of events 1 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/38 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/6 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/33 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/40 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/32 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
3.1%
1/32 • Number of events 1 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/38 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/6 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
3.0%
1/33 • Number of events 1 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/40 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/32 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/32 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/38 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/6 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/33 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
2.5%
1/40 • Number of events 1 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/32 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/32 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/38 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
3.0%
1/33 • Number of events 1 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/40 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/32 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/32 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/38 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Irregular breathing
|
0.00%
0/6 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
3.0%
1/33 • Number of events 1 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/40 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/32 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/32 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/38 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
Other adverse events
| Measure |
MK-1654 20 mg in Pre-term Infants
n=6 participants at risk
Pre-term infants received clesrovimab 20mg via intramuscular (IM) injection and were followed for up to 365 days.
|
MK-1654 50 mg in Pre-term Infants
n=33 participants at risk
Pre-term infants received clesrovimab 50mg via IM injection and were followed for up to 365 days.
|
MK-1654 75 mg in Pre-term Infants
n=40 participants at risk
Pre-term infants received clesrovimab 75mg via IM injection and were followed for up to 365 days.
|
MK-1654 100 mg Pre-Term Infants
n=32 participants at risk
Pre-term infants in Panel D1 and D2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.
|
MK-1654 100 mg Full-Term Infants
n=32 participants at risk
Full-term infants in Panel E1 and E2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.
|
Placebo
n=38 participants at risk
Pre-term and Full-term infants received placebo via IM injection.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • Number of events 1 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/33 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/40 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/32 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
6.2%
2/32 • Number of events 2 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/38 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
15.2%
5/33 • Number of events 5 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
5.0%
2/40 • Number of events 2 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
6.2%
2/32 • Number of events 2 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
12.5%
4/32 • Number of events 4 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
13.2%
5/38 • Number of events 5 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/6 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/33 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
7.5%
3/40 • Number of events 3 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/32 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/32 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/38 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
|
Gastrointestinal disorders
Teething
|
0.00%
0/6 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
3.0%
1/33 • Number of events 2 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/40 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/32 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
9.4%
3/32 • Number of events 3 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/38 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
|
General disorders
Injection site erythema
|
16.7%
1/6 • Number of events 1 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
6.1%
2/33 • Number of events 2 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
2.5%
1/40 • Number of events 1 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
3.1%
1/32 • Number of events 1 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
3.1%
1/32 • Number of events 1 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
2.6%
1/38 • Number of events 1 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
|
General disorders
Injection site pain
|
33.3%
2/6 • Number of events 2 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/33 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
5.0%
2/40 • Number of events 3 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
6.2%
2/32 • Number of events 2 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/32 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
2.6%
1/38 • Number of events 2 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
|
General disorders
Injection site swelling
|
33.3%
2/6 • Number of events 2 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
3.0%
1/33 • Number of events 1 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/40 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/32 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
3.1%
1/32 • Number of events 2 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
2.6%
1/38 • Number of events 1 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
3.0%
1/33 • Number of events 1 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/40 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
6.2%
2/32 • Number of events 2 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
3.1%
1/32 • Number of events 2 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
2.6%
1/38 • Number of events 1 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
|
Infections and infestations
Bronchiolitis
|
33.3%
2/6 • Number of events 3 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
6.1%
2/33 • Number of events 3 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
10.0%
4/40 • Number of events 6 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
21.9%
7/32 • Number of events 8 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
15.6%
5/32 • Number of events 6 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
13.2%
5/38 • Number of events 9 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/6 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
9.1%
3/33 • Number of events 7 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
7.5%
3/40 • Number of events 4 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
3.1%
1/32 • Number of events 1 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
3.1%
1/32 • Number of events 1 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
2.6%
1/38 • Number of events 1 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
|
Infections and infestations
COVID-19
|
0.00%
0/6 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/33 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
5.0%
2/40 • Number of events 2 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/32 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
6.2%
2/32 • Number of events 2 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
7.9%
3/38 • Number of events 3 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/6 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/33 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/40 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
3.1%
1/32 • Number of events 1 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
6.2%
2/32 • Number of events 2 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/38 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
|
Infections and infestations
Croup infectious
|
0.00%
0/6 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/33 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
2.5%
1/40 • Number of events 1 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/32 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
9.4%
3/32 • Number of events 5 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
5.3%
2/38 • Number of events 2 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
|
Infections and infestations
Ear infection
|
0.00%
0/6 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/33 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/40 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
6.2%
2/32 • Number of events 2 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
3.1%
1/32 • Number of events 1 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/38 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/6 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
3.0%
1/33 • Number of events 1 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/40 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
3.1%
1/32 • Number of events 1 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
18.8%
6/32 • Number of events 8 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/38 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/6 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
3.0%
1/33 • Number of events 1 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/40 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
6.2%
2/32 • Number of events 2 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
6.2%
2/32 • Number of events 2 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
2.6%
1/38 • Number of events 1 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
|
Infections and infestations
Nasopharyngitis
|
16.7%
1/6 • Number of events 1 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
6.1%
2/33 • Number of events 7 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
27.5%
11/40 • Number of events 19 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
31.2%
10/32 • Number of events 20 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
31.2%
10/32 • Number of events 22 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
18.4%
7/38 • Number of events 19 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
|
Infections and infestations
Otitis media
|
0.00%
0/6 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/33 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/40 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
3.1%
1/32 • Number of events 1 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
3.1%
1/32 • Number of events 5 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
7.9%
3/38 • Number of events 3 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/6 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/33 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/40 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/32 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
3.1%
1/32 • Number of events 1 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
5.3%
2/38 • Number of events 2 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/6 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
3.0%
1/33 • Number of events 1 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/40 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
3.1%
1/32 • Number of events 1 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
6.2%
2/32 • Number of events 2 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/38 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/6 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/33 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
2.5%
1/40 • Number of events 1 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/32 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/32 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
5.3%
2/38 • Number of events 2 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
|
Infections and infestations
Upper respiratory tract infection
|
33.3%
2/6 • Number of events 2 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
51.5%
17/33 • Number of events 22 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
17.5%
7/40 • Number of events 8 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
37.5%
12/32 • Number of events 19 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
56.2%
18/32 • Number of events 52 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
31.6%
12/38 • Number of events 22 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
|
Infections and infestations
Viral pharyngitis
|
0.00%
0/6 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/33 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/40 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/32 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
6.2%
2/32 • Number of events 2 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
2.6%
1/38 • Number of events 1 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/6 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
6.1%
2/33 • Number of events 2 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/40 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
3.1%
1/32 • Number of events 1 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
3.1%
1/32 • Number of events 1 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
13.2%
5/38 • Number of events 7 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/6 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
6.1%
2/33 • Number of events 2 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/40 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/32 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/32 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/38 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
|
Injury, poisoning and procedural complications
Contusion
|
16.7%
1/6 • Number of events 1 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/33 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/40 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/32 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/32 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/38 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.7%
1/6 • Number of events 1 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
3.0%
1/33 • Number of events 1 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/40 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/32 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/32 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
2.6%
1/38 • Number of events 1 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
|
Nervous system disorders
Somnolence
|
16.7%
1/6 • Number of events 1 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
6.1%
2/33 • Number of events 2 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
12.5%
5/40 • Number of events 5 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
3.1%
1/32 • Number of events 1 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
3.1%
1/32 • Number of events 1 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
10.5%
4/38 • Number of events 4 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
|
Psychiatric disorders
Irritability
|
33.3%
2/6 • Number of events 2 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
21.2%
7/33 • Number of events 7 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
12.5%
5/40 • Number of events 6 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
6.2%
2/32 • Number of events 2 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
6.2%
2/32 • Number of events 2 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
23.7%
9/38 • Number of events 10 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • Number of events 1 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
9.1%
3/33 • Number of events 3 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
2.5%
1/40 • Number of events 1 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
6.2%
2/32 • Number of events 3 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
9.4%
3/32 • Number of events 8 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
5.3%
2/38 • Number of events 2 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
33.3%
2/6 • Number of events 2 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
15.2%
5/33 • Number of events 6 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
5.0%
2/40 • Number of events 2 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
18.8%
6/32 • Number of events 6 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
25.0%
8/32 • Number of events 11 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
13.2%
5/38 • Number of events 5 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
16.7%
1/6 • Number of events 1 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
6.1%
2/33 • Number of events 2 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
2.5%
1/40 • Number of events 1 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
12.5%
4/32 • Number of events 6 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
9.4%
3/32 • Number of events 11 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
2.6%
1/38 • Number of events 1 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
16.7%
1/6 • Number of events 1 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
6.1%
2/33 • Number of events 2 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/40 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
6.2%
2/32 • Number of events 2 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
3.1%
1/32 • Number of events 1 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
2.6%
1/38 • Number of events 1 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/6 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/33 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/40 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
6.2%
2/32 • Number of events 2 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
3.1%
1/32 • Number of events 1 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
2.6%
1/38 • Number of events 1 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
1/6 • Number of events 1 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/33 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/40 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/32 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/32 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/38 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
3.0%
1/33 • Number of events 1 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
2.5%
1/40 • Number of events 1 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
6.2%
2/32 • Number of events 2 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/32 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/38 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/6 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/33 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/40 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/32 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/32 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
5.3%
2/38 • Number of events 2 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/6 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
3.0%
1/33 • Number of events 1 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/40 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/32 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
12.5%
4/32 • Number of events 4 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
0.00%
0/38 • Up to Day 545
All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
- Publication restrictions are in place
Restriction type: OTHER