Trial Outcomes & Findings for A Study of MK-2214 in Adults With Mild Cognitive Impairment or Mild-to-Moderate Alzheimer's Disease (MK-2214-002) (NCT NCT05466422)
NCT ID: NCT05466422
Last Updated: 2026-09-03
Results Overview
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinued study treatment due to an AE was reported.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
34 participants
Primary outcome timeframe
Up to approximately 57 days
Results posted on
2026-09-03
Participant Flow
Thirty-four participants were randomized and received study treatment in 1 of 4 panels (Part 1: Panels A through D). In each panel, participants received MK-2214 or placebo. As specified by Phase 1 flexible dose regimen in the protocol, MK-2214 dose in Panel D was modified to obtain additional pharmacokinetic and pharmacodynamic data. Part 2 (Panels E and F) was optional and was not conducted.
Participant milestones
| Measure |
Panel A: MK-2214 20 mg
Participants were randomized to receive MK-2214 20 mg as an intravenous (IV) infusion every month (qm) for 3 months (on Days 1, 29, and 57).
|
Panel B: MK-2214 100 mg
Participants were randomized to receive MK-2214 100 mg as an IV infusion qm for 3 months (on Days 1, 29, and 57).
|
Panel C: MK-2214 500 mg
Participants were randomized to receive MK-2214 500 mg as an IV infusion qm for 3 months (on Days 1, 29, and 57).
|
Panel D: MK-2214 4 mg
Participants were randomized to receive MK-2214 4 mg as an IV infusion qm for 3 months (on Days 1, 29, and 57).
|
Placebo
Participants were randomized to receive placebo as an IV infusion qm for 3 months (on Days 1, 29, and 57).
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
6
|
6
|
6
|
9
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
5
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
1
|
2
|
Reasons for withdrawal
| Measure |
Panel A: MK-2214 20 mg
Participants were randomized to receive MK-2214 20 mg as an intravenous (IV) infusion every month (qm) for 3 months (on Days 1, 29, and 57).
|
Panel B: MK-2214 100 mg
Participants were randomized to receive MK-2214 100 mg as an IV infusion qm for 3 months (on Days 1, 29, and 57).
|
Panel C: MK-2214 500 mg
Participants were randomized to receive MK-2214 500 mg as an IV infusion qm for 3 months (on Days 1, 29, and 57).
|
Panel D: MK-2214 4 mg
Participants were randomized to receive MK-2214 4 mg as an IV infusion qm for 3 months (on Days 1, 29, and 57).
|
Placebo
Participants were randomized to receive placebo as an IV infusion qm for 3 months (on Days 1, 29, and 57).
|
|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Sponsor Decision
|
0
|
0
|
0
|
1
|
2
|
Baseline Characteristics
A Study of MK-2214 in Adults With Mild Cognitive Impairment or Mild-to-Moderate Alzheimer's Disease (MK-2214-002)
Baseline characteristics by cohort
| Measure |
Panel A: MK-2214 20 mg
n=7 Participants
Participants were randomized to receive MK-2214 20 mg as an intravenous (IV) infusion every month (qm) for 3 months (on Days 1, 29, and 57).
|
Panel B: MK-2214 100 mg
n=6 Participants
Participants were randomized to receive MK-2214 100 mg as an IV infusion qm for 3 months (on Days 1, 29, and 57).
|
Panel C: MK-2214 500 mg
n=6 Participants
Participants were randomized to receive MK-2214 500 mg as an IV infusion qm for 3 months (on Days 1, 29, and 57).
|
Panel D: MK-2214 4 mg
n=6 Participants
Participants were randomized to receive MK-2214 4 mg as an IV infusion qm for 3 months (on Days 1, 29, and 57).
|
Placebo
n=9 Participants
Participants were randomized to receive placebo as an IV infusion qm for 3 months (on Days 1, 29, and 57).
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
73.1 Years
STANDARD_DEVIATION 9.5 • n=136 Participants
|
68.3 Years
STANDARD_DEVIATION 4.3 • n=136 Participants
|
71.2 Years
STANDARD_DEVIATION 8.5 • n=272 Participants
|
73.3 Years
STANDARD_DEVIATION 3.1 • n=60 Participants
|
68.9 Years
STANDARD_DEVIATION 8.2 • n=58 Participants
|
70.9 Years
STANDARD_DEVIATION 7.2 • n=62 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=136 Participants
|
4 Participants
n=136 Participants
|
3 Participants
n=272 Participants
|
4 Participants
n=60 Participants
|
4 Participants
n=58 Participants
|
18 Participants
n=62 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=136 Participants
|
2 Participants
n=136 Participants
|
3 Participants
n=272 Participants
|
2 Participants
n=60 Participants
|
5 Participants
n=58 Participants
|
16 Participants
n=62 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=136 Participants
|
3 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
1 Participants
n=60 Participants
|
4 Participants
n=58 Participants
|
11 Participants
n=62 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=136 Participants
|
3 Participants
n=136 Participants
|
6 Participants
n=272 Participants
|
5 Participants
n=60 Participants
|
5 Participants
n=58 Participants
|
23 Participants
n=62 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=58 Participants
|
0 Participants
n=62 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=58 Participants
|
0 Participants
n=62 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
1 Participants
n=60 Participants
|
0 Participants
n=58 Participants
|
1 Participants
n=62 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=58 Participants
|
0 Participants
n=62 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=136 Participants
|
2 Participants
n=136 Participants
|
1 Participants
n=272 Participants
|
1 Participants
n=60 Participants
|
0 Participants
n=58 Participants
|
5 Participants
n=62 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=136 Participants
|
4 Participants
n=136 Participants
|
5 Participants
n=272 Participants
|
4 Participants
n=60 Participants
|
9 Participants
n=58 Participants
|
28 Participants
n=62 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=58 Participants
|
0 Participants
n=62 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=58 Participants
|
0 Participants
n=62 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 297 daysPopulation: All randomized participants who received at least 1 dose of study treatment.
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experienced at least one AE was reported.
Outcome measures
| Measure |
Panel A: MK-2214 20 mg
n=7 Participants
Participants were randomized to receive MK-2214 20 mg as an intravenous (IV) infusion every month (qm) for 3 months (on Days 1, 29, and 57).
|
Panel B: MK-2214 100 mg
n=6 Participants
Participants were randomized to receive MK-2214 100 mg as an IV infusion qm for 3 months (on Days 1, 29, and 57).
|
Panel C: MK-2214 500 mg
n=6 Participants
Participants were randomized to receive MK-2214 500 mg as an IV infusion qm for 3 months (on Days 1, 29, and 57).
|
Panel D: MK-2214 4 mg
n=6 Participants
Participants were randomized to receive MK-2214 4 mg as an IV infusion qm for 3 months (on Days 1, 29, and 57).
|
Placebo
n=9 Participants
Participants were randomized to receive placebo as an IV infusion qm for 3 months (on Days 1, 29, and 57).
|
|---|---|---|---|---|---|
|
Number of Participants Who Experienced an Adverse Event (AE)
|
5 Participants
|
5 Participants
|
4 Participants
|
5 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 57 daysPopulation: All randomized participants who received at least 1 dose of study treatment.
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinued study treatment due to an AE was reported.
Outcome measures
| Measure |
Panel A: MK-2214 20 mg
n=7 Participants
Participants were randomized to receive MK-2214 20 mg as an intravenous (IV) infusion every month (qm) for 3 months (on Days 1, 29, and 57).
|
Panel B: MK-2214 100 mg
n=6 Participants
Participants were randomized to receive MK-2214 100 mg as an IV infusion qm for 3 months (on Days 1, 29, and 57).
|
Panel C: MK-2214 500 mg
n=6 Participants
Participants were randomized to receive MK-2214 500 mg as an IV infusion qm for 3 months (on Days 1, 29, and 57).
|
Panel D: MK-2214 4 mg
n=6 Participants
Participants were randomized to receive MK-2214 4 mg as an IV infusion qm for 3 months (on Days 1, 29, and 57).
|
Placebo
n=9 Participants
Participants were randomized to receive placebo as an IV infusion qm for 3 months (on Days 1, 29, and 57).
|
|---|---|---|---|---|---|
|
Number of Participants Who Discontinued Study Treatment Due to an AE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 8, 12, and 24 hours post first dose (Day 1), Day 4, Day 8, Day 15, and predose on Day 29Population: All randomized participants who received at least 1 dose of MK-2214, were compliant with study procedures, and had AUC0-28 data available after first dose (Day 1).
AUC0-28 was defined as the area under the concentration-time curve from time 0 to 28 days of MK-2214 in serum. Blood samples were collected at prespecified time points to determine AUC0-28 of MK-2214 in serum after first dose (Day 1).
Outcome measures
| Measure |
Panel A: MK-2214 20 mg
n=7 Participants
Participants were randomized to receive MK-2214 20 mg as an intravenous (IV) infusion every month (qm) for 3 months (on Days 1, 29, and 57).
|
Panel B: MK-2214 100 mg
n=6 Participants
Participants were randomized to receive MK-2214 100 mg as an IV infusion qm for 3 months (on Days 1, 29, and 57).
|
Panel C: MK-2214 500 mg
n=6 Participants
Participants were randomized to receive MK-2214 500 mg as an IV infusion qm for 3 months (on Days 1, 29, and 57).
|
Panel D: MK-2214 4 mg
n=6 Participants
Participants were randomized to receive MK-2214 4 mg as an IV infusion qm for 3 months (on Days 1, 29, and 57).
|
Placebo
Participants were randomized to receive placebo as an IV infusion qm for 3 months (on Days 1, 29, and 57).
|
|---|---|---|---|---|---|
|
Area Under the Concentration-Time Curve From Time 0 to 28 Days (AUC0-28) of MK-2214 in Serum After First Dose (Day 1)
|
1090000 h*µg/L
Interval 855000.0 to 1390000.0
|
5730000 h*µg/L
Interval 4410000.0 to 7440000.0
|
25000000 h*µg/L
Interval 19300000.0 to 32500000.0
|
200000 h*µg/L
Interval 154000.0 to 259000.0
|
—
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 8, 12, and 24 hours post third dose (Day 57), Day 60, Day 64, Day 71, Day 85, Day 141, Day 197, Day 247, and Day 297Population: All randomized participants who received 3 doses of MK-2214, were compliant with study procedures, and had AUC0-28 data available after third dose (Day 57).
AUC0-28 was defined as the area under the concentration-time curve from time 0 to 28 days of MK-2214 in serum. Blood samples were collected at prespecified time points to determine AUC0-28 of MK-2214 in serum after third dose (Day 57).
Outcome measures
| Measure |
Panel A: MK-2214 20 mg
n=6 Participants
Participants were randomized to receive MK-2214 20 mg as an intravenous (IV) infusion every month (qm) for 3 months (on Days 1, 29, and 57).
|
Panel B: MK-2214 100 mg
n=6 Participants
Participants were randomized to receive MK-2214 100 mg as an IV infusion qm for 3 months (on Days 1, 29, and 57).
|
Panel C: MK-2214 500 mg
n=6 Participants
Participants were randomized to receive MK-2214 500 mg as an IV infusion qm for 3 months (on Days 1, 29, and 57).
|
Panel D: MK-2214 4 mg
n=5 Participants
Participants were randomized to receive MK-2214 4 mg as an IV infusion qm for 3 months (on Days 1, 29, and 57).
|
Placebo
Participants were randomized to receive placebo as an IV infusion qm for 3 months (on Days 1, 29, and 57).
|
|---|---|---|---|---|---|
|
AUC0-28 of MK-2214 in Serum After Third Dose (Day 57)
|
2030000 h*µg/L
Interval 1580000.0 to 2610000.0
|
13000000 h*µg/L
Interval 9990000.0 to 16800000.0
|
49800000 h*µg/L
Interval 38300000.0 to 64600000.0
|
325000 h*µg/L
Interval 247000.0 to 428000.0
|
—
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 8, 12, and 24 hours post first dose (Day 1), Day 4, Day 8, Day 15, and predose on Day 29Population: All randomized participants who received at least 1 dose of MK-2214, were compliant with study procedures, and had Cmax data available after first dose (Day 1).
Cmax was defined as the maximum concentration of MK-2214 observed in serum. Blood samples were collected at prespecified time points to determine Cmax of MK-2214 after first dose (Day 1).
Outcome measures
| Measure |
Panel A: MK-2214 20 mg
n=7 Participants
Participants were randomized to receive MK-2214 20 mg as an intravenous (IV) infusion every month (qm) for 3 months (on Days 1, 29, and 57).
|
Panel B: MK-2214 100 mg
n=6 Participants
Participants were randomized to receive MK-2214 100 mg as an IV infusion qm for 3 months (on Days 1, 29, and 57).
|
Panel C: MK-2214 500 mg
n=6 Participants
Participants were randomized to receive MK-2214 500 mg as an IV infusion qm for 3 months (on Days 1, 29, and 57).
|
Panel D: MK-2214 4 mg
n=6 Participants
Participants were randomized to receive MK-2214 4 mg as an IV infusion qm for 3 months (on Days 1, 29, and 57).
|
Placebo
Participants were randomized to receive placebo as an IV infusion qm for 3 months (on Days 1, 29, and 57).
|
|---|---|---|---|---|---|
|
Maximum Serum Concentration (Cmax) of MK-2214 After First Dose (Day 1)
|
5360 µg/L
Interval 3960.0 to 7250.0
|
29600 µg/L
Interval 21400.0 to 41100.0
|
129000 µg/L
Interval 93200.0 to 179000.0
|
980 µg/L
Interval 707.0 to 1360.0
|
—
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 8, 12, and 24 hours post third dose (Day 57), Day 60, Day 64, Day 71, Day 85, Day 141, Day 197, Day 247, and Day 297Population: All randomized participants who received 3 doses of MK-2214, were compliant with study procedures, and had Cmax data available after third dose (Day 57).
Cmax was defined as the maximum concentration of MK-2214 observed in serum. Blood samples were collected at prespecified time points to determine Cmax of MK-2214 after third dose (Day 57).
Outcome measures
| Measure |
Panel A: MK-2214 20 mg
n=6 Participants
Participants were randomized to receive MK-2214 20 mg as an intravenous (IV) infusion every month (qm) for 3 months (on Days 1, 29, and 57).
|
Panel B: MK-2214 100 mg
n=6 Participants
Participants were randomized to receive MK-2214 100 mg as an IV infusion qm for 3 months (on Days 1, 29, and 57).
|
Panel C: MK-2214 500 mg
n=6 Participants
Participants were randomized to receive MK-2214 500 mg as an IV infusion qm for 3 months (on Days 1, 29, and 57).
|
Panel D: MK-2214 4 mg
n=5 Participants
Participants were randomized to receive MK-2214 4 mg as an IV infusion qm for 3 months (on Days 1, 29, and 57).
|
Placebo
Participants were randomized to receive placebo as an IV infusion qm for 3 months (on Days 1, 29, and 57).
|
|---|---|---|---|---|---|
|
Cmax of MK-2214 After Third Dose (Day 57)
|
7300 µg/L
Interval 5280.0 to 10100.0
|
39400 µg/L
Interval 28400.0 to 54600.0
|
167000 µg/L
Interval 120000.0 to 231000.0
|
1200 µg/L
Interval 845.0 to 1710.0
|
—
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 8, 12, and 24 hours post first dose (Day 1), Day 4, Day 8, Day 15, and predose on Day 29Population: All randomized participants who received at least 1 dose of MK-2214, were compliant with study procedures, and had Tmax data available after first dose (Day 1).
Tmax was defined as the time to maximum serum concentration of MK-2214. Blood samples were collected at prespecified time points to determine Tmax of MK-2214 in serum after first dose (Day 1).
Outcome measures
| Measure |
Panel A: MK-2214 20 mg
n=7 Participants
Participants were randomized to receive MK-2214 20 mg as an intravenous (IV) infusion every month (qm) for 3 months (on Days 1, 29, and 57).
|
Panel B: MK-2214 100 mg
n=6 Participants
Participants were randomized to receive MK-2214 100 mg as an IV infusion qm for 3 months (on Days 1, 29, and 57).
|
Panel C: MK-2214 500 mg
n=6 Participants
Participants were randomized to receive MK-2214 500 mg as an IV infusion qm for 3 months (on Days 1, 29, and 57).
|
Panel D: MK-2214 4 mg
n=6 Participants
Participants were randomized to receive MK-2214 4 mg as an IV infusion qm for 3 months (on Days 1, 29, and 57).
|
Placebo
Participants were randomized to receive placebo as an IV infusion qm for 3 months (on Days 1, 29, and 57).
|
|---|---|---|---|---|---|
|
Time of Maximum Serum Concentration (Tmax) of MK-2214 After First Dose (Day 1)
|
1.00 hr
Interval 0.5 to 23.97
|
1.29 hr
Interval 0.53 to 2.05
|
1.01 hr
Interval 0.55 to 12.02
|
1.03 hr
Interval 0.12 to 2.0
|
—
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 8, 12, and 24 hours post third dose (Day 57), Day 60, Day 64, Day 71, Day 85, Day 141, Day 197, Day 247, and Day 297Population: All randomized participants who received 3 doses of MK-2214, were compliant with study procedures, and had Tmax data available after third dose (Day 57).
Tmax was defined as the time to maximum serum concentration of MK-2214. Blood samples were collected at prespecified time points to determine Tmax of MK-2214 in serum after third dose (Day 57).
Outcome measures
| Measure |
Panel A: MK-2214 20 mg
n=6 Participants
Participants were randomized to receive MK-2214 20 mg as an intravenous (IV) infusion every month (qm) for 3 months (on Days 1, 29, and 57).
|
Panel B: MK-2214 100 mg
n=6 Participants
Participants were randomized to receive MK-2214 100 mg as an IV infusion qm for 3 months (on Days 1, 29, and 57).
|
Panel C: MK-2214 500 mg
n=6 Participants
Participants were randomized to receive MK-2214 500 mg as an IV infusion qm for 3 months (on Days 1, 29, and 57).
|
Panel D: MK-2214 4 mg
n=5 Participants
Participants were randomized to receive MK-2214 4 mg as an IV infusion qm for 3 months (on Days 1, 29, and 57).
|
Placebo
Participants were randomized to receive placebo as an IV infusion qm for 3 months (on Days 1, 29, and 57).
|
|---|---|---|---|---|---|
|
Tmax of MK-2214 After Third Dose (Day 57)
|
1.03 hr
Interval 0.53 to 3.98
|
3.99 hr
Interval 1.35 to 672.27
|
2.02 hr
Interval 0.52 to 4.07
|
1.00 hr
Interval 0.12 to 4.03
|
—
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 8, 12, and 24 hours post third dose (Day 57), Day 60, Day 64, Day 71, Day 85, Day 141, Day 197, Day 247, and Day 297Population: All randomized participants who received 3 doses of MK-2214, were compliant with study procedures, and had t1/2 data available after third dose (Day 57).
T1/2 was defined as the apparent half-life of MK-2214 observed in serum. Blood samples were collected at prespecified time points to determine t1/2 of MK-2214 in serum after third dose (Day 57).
Outcome measures
| Measure |
Panel A: MK-2214 20 mg
n=6 Participants
Participants were randomized to receive MK-2214 20 mg as an intravenous (IV) infusion every month (qm) for 3 months (on Days 1, 29, and 57).
|
Panel B: MK-2214 100 mg
n=6 Participants
Participants were randomized to receive MK-2214 100 mg as an IV infusion qm for 3 months (on Days 1, 29, and 57).
|
Panel C: MK-2214 500 mg
n=6 Participants
Participants were randomized to receive MK-2214 500 mg as an IV infusion qm for 3 months (on Days 1, 29, and 57).
|
Panel D: MK-2214 4 mg
n=5 Participants
Participants were randomized to receive MK-2214 4 mg as an IV infusion qm for 3 months (on Days 1, 29, and 57).
|
Placebo
Participants were randomized to receive placebo as an IV infusion qm for 3 months (on Days 1, 29, and 57).
|
|---|---|---|---|---|---|
|
Apparent Half-Life (T1/2) of MK-2214 in Serum After Third Dose (Day 57)
|
1964.6 hr
Geometric Coefficient of Variation 23.1
|
1519.5 hr
Geometric Coefficient of Variation 41.8
|
2016.5 hr
Geometric Coefficient of Variation 18.0
|
2204.6 hr
Geometric Coefficient of Variation 16.6
|
—
|
PRIMARY outcome
Timeframe: Day 85Population: All randomized participants who received at least 1 dose of MK-2214, were compliant with study procedures, and had CSF concentration of MK-2214 or serum concentration of MK-2214 data available on Day 85.
Concentration of MK-2214 in CSF was defined as the CSF exposure of MK-2214. A CSF sample was to be collected on Day 85.
Outcome measures
| Measure |
Panel A: MK-2214 20 mg
n=6 Participants
Participants were randomized to receive MK-2214 20 mg as an intravenous (IV) infusion every month (qm) for 3 months (on Days 1, 29, and 57).
|
Panel B: MK-2214 100 mg
n=6 Participants
Participants were randomized to receive MK-2214 100 mg as an IV infusion qm for 3 months (on Days 1, 29, and 57).
|
Panel C: MK-2214 500 mg
n=6 Participants
Participants were randomized to receive MK-2214 500 mg as an IV infusion qm for 3 months (on Days 1, 29, and 57).
|
Panel D: MK-2214 4 mg
n=6 Participants
Participants were randomized to receive MK-2214 4 mg as an IV infusion qm for 3 months (on Days 1, 29, and 57).
|
Placebo
Participants were randomized to receive placebo as an IV infusion qm for 3 months (on Days 1, 29, and 57).
|
|---|---|---|---|---|---|
|
Concentration of MK-2214 in Cerebrospinal Fluid (CSF) at Day 85
|
0.0487 nM
Interval 0.0258 to 0.092
|
0.378 nM
Interval 0.2 to 0.714
|
1.13 nM
Interval 0.596 to 2.12
|
0.00655 nM
Interval 0.00347 to 0.0124
|
—
|
PRIMARY outcome
Timeframe: Day 85Population: All randomized participants who received ≥1 dose of study treatment, were compliant with study procedures, and had CSF free phospho-tau concentration data available on Day 85. CSF free phospho-tau data was not collected on Day 85 for participants in Panel D; the Panel D dose was reduced to 4 mg, with CSF free phospho-tau collected only until 28 days, based on projections from Panels A-C indicating many Day 85 pharmacodynamic measurements would likely fall below the lower limit of quantitation.
Concentration of free phospo-tau in CSF was defined as free phospho-tau levels in CSF after study treatment administration (MK-2214 or placebo). A CSF sample was to be collected on Day 85.
Outcome measures
| Measure |
Panel A: MK-2214 20 mg
n=4 Participants
Participants were randomized to receive MK-2214 20 mg as an intravenous (IV) infusion every month (qm) for 3 months (on Days 1, 29, and 57).
|
Panel B: MK-2214 100 mg
n=2 Participants
Participants were randomized to receive MK-2214 100 mg as an IV infusion qm for 3 months (on Days 1, 29, and 57).
|
Panel C: MK-2214 500 mg
n=3 Participants
Participants were randomized to receive MK-2214 500 mg as an IV infusion qm for 3 months (on Days 1, 29, and 57).
|
Panel D: MK-2214 4 mg
Participants were randomized to receive MK-2214 4 mg as an IV infusion qm for 3 months (on Days 1, 29, and 57).
|
Placebo
n=3 Participants
Participants were randomized to receive placebo as an IV infusion qm for 3 months (on Days 1, 29, and 57).
|
|---|---|---|---|---|---|
|
Free Phospho-Tau Concentration in CSF
|
4.1 fM
Standard Deviation 0.00
|
4.1 fM
Standard Deviation 0.00
|
4.1 fM
Standard Deviation 0.00
|
—
|
13 fM
Standard Deviation 3.2
|
Adverse Events
MK-2214 20 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
MK-2214 100 mg
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
MK-2214 500 mg
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
MK-2214 4 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
MK-2214 Total
Serious events: 3 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MK-2214 20 mg
n=7 participants at risk
Participants were randomized to receive MK-2214 20 mg as an IV infusion qm for 3 months (on Days 1, 29, and 57).
|
MK-2214 100 mg
n=6 participants at risk
Participants were randomized to receive MK-2214 100 mg as an IV infusion qm for 3 months (on Days 1, 29, and 57).
|
MK-2214 500 mg
n=6 participants at risk
Participants were randomized to receive MK-2214 500 mg as an IV infusion qm for 3 months (on Days 1, 29, and 57).
|
MK-2214 4 mg
n=6 participants at risk
Participants were randomized to receive MK-2214 4 mg as an IV infusion qm for 3 months (on Days 1, 29, and 57).
|
Placebo
n=9 participants at risk
Participants were randomized to receive placebo as an IV infusion qm for 3 months (on Days 1, 29, and 57).
|
MK-2214 Total
n=25 participants at risk
All participants who received at least 1 dose of MK-2214.
|
|---|---|---|---|---|---|---|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/7 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
16.7%
1/6 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/9 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
4.0%
1/25 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
|
Hepatobiliary disorders
Hepatic lesion
|
0.00%
0/7 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
16.7%
1/6 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/9 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
4.0%
1/25 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/7 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
16.7%
1/6 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/9 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
4.0%
1/25 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/7 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
16.7%
1/6 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/9 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
4.0%
1/25 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
|
Infections and infestations
Sepsis
|
0.00%
0/7 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
16.7%
1/6 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/9 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
4.0%
1/25 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/7 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
16.7%
1/6 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/9 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
4.0%
1/25 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
|
Nervous system disorders
Seizure
|
0.00%
0/7 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
11.1%
1/9 • Number of events 2 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/25 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/7 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
16.7%
1/6 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/9 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
4.0%
1/25 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
Other adverse events
| Measure |
MK-2214 20 mg
n=7 participants at risk
Participants were randomized to receive MK-2214 20 mg as an IV infusion qm for 3 months (on Days 1, 29, and 57).
|
MK-2214 100 mg
n=6 participants at risk
Participants were randomized to receive MK-2214 100 mg as an IV infusion qm for 3 months (on Days 1, 29, and 57).
|
MK-2214 500 mg
n=6 participants at risk
Participants were randomized to receive MK-2214 500 mg as an IV infusion qm for 3 months (on Days 1, 29, and 57).
|
MK-2214 4 mg
n=6 participants at risk
Participants were randomized to receive MK-2214 4 mg as an IV infusion qm for 3 months (on Days 1, 29, and 57).
|
Placebo
n=9 participants at risk
Participants were randomized to receive placebo as an IV infusion qm for 3 months (on Days 1, 29, and 57).
|
MK-2214 Total
n=25 participants at risk
All participants who received at least 1 dose of MK-2214.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/7 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
16.7%
1/6 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/9 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
4.0%
1/25 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/7 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
11.1%
1/9 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/25 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
|
Blood and lymphatic system disorders
Normocytic anaemia
|
0.00%
0/7 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
16.7%
1/6 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/9 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
4.0%
1/25 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
|
Cardiac disorders
Atrioventricular block first degree
|
14.3%
1/7 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/9 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
4.0%
1/25 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/7 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
11.1%
1/9 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/25 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
|
Cardiac disorders
Pulmonary valve incompetence
|
0.00%
0/7 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
11.1%
1/9 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/25 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/7 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
16.7%
1/6 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/9 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
4.0%
1/25 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/7 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
16.7%
1/6 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/9 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
4.0%
1/25 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/7 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
11.1%
1/9 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/25 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/7 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
11.1%
1/9 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/25 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
|
General disorders
Fatigue
|
0.00%
0/7 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
16.7%
1/6 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/9 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
4.0%
1/25 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
|
General disorders
Generalised oedema
|
0.00%
0/7 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
16.7%
1/6 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/9 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
4.0%
1/25 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
|
General disorders
Infusion site extravasation
|
0.00%
0/7 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
11.1%
1/9 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/25 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
|
General disorders
Pain
|
0.00%
0/7 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
11.1%
1/9 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/25 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
|
General disorders
Peripheral swelling
|
0.00%
0/7 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
16.7%
1/6 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/9 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
4.0%
1/25 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
|
Infections and infestations
Influenza
|
0.00%
0/7 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
16.7%
1/6 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/9 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
4.0%
1/25 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
|
Infections and infestations
Parvimonas infection
|
0.00%
0/7 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
16.7%
1/6 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/9 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
4.0%
1/25 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
|
Infections and infestations
Pyuria
|
0.00%
0/7 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
11.1%
1/9 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/25 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/7 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
16.7%
1/6 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/9 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
4.0%
1/25 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
|
Infections and infestations
Upper respiratory tract infection
|
14.3%
1/7 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/9 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
4.0%
1/25 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/7 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
16.7%
1/6 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
22.2%
2/9 • Number of events 3 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
4.0%
1/25 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
|
Injury, poisoning and procedural complications
Tongue injury
|
0.00%
0/7 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
11.1%
1/9 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/25 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/7 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
16.7%
1/6 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/9 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
4.0%
1/25 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/7 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
16.7%
1/6 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/9 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
4.0%
1/25 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/7 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
16.7%
1/6 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/9 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
4.0%
1/25 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/7 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
16.7%
1/6 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/9 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
4.0%
1/25 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/7 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
16.7%
1/6 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
11.1%
1/9 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
4.0%
1/25 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
1/7 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
16.7%
1/6 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
11.1%
1/9 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
8.0%
2/25 • Number of events 2 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/7 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
16.7%
1/6 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/9 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
4.0%
1/25 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.3%
1/7 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
33.3%
2/6 • Number of events 2 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/9 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
12.0%
3/25 • Number of events 3 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/7 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
11.1%
1/9 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/25 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
14.3%
1/7 • Number of events 2 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/9 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
4.0%
1/25 • Number of events 2 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.00%
0/7 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
11.1%
1/9 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/25 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/7 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
16.7%
1/6 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/9 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
4.0%
1/25 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
|
Nervous system disorders
Cerebral microhaemorrhage
|
0.00%
0/7 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
11.1%
1/9 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/25 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/7 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
16.7%
1/6 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
33.3%
2/6 • Number of events 2 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
11.1%
1/9 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
12.0%
3/25 • Number of events 3 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
|
Nervous system disorders
Encephalomalacia
|
0.00%
0/7 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
11.1%
1/9 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/25 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
|
Nervous system disorders
Gliosis
|
0.00%
0/7 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
11.1%
1/9 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/25 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
|
Nervous system disorders
Headache
|
14.3%
1/7 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
16.7%
1/6 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
50.0%
3/6 • Number of events 4 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
33.3%
2/6 • Number of events 4 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
22.2%
2/9 • Number of events 2 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
28.0%
7/25 • Number of events 10 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/7 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
16.7%
1/6 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/9 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
4.0%
1/25 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
|
Nervous system disorders
Tremor
|
0.00%
0/7 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
11.1%
1/9 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/25 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/7 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
16.7%
1/6 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/9 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
4.0%
1/25 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
|
Psychiatric disorders
Depression
|
0.00%
0/7 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
11.1%
1/9 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/25 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/7 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
16.7%
1/6 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/9 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
4.0%
1/25 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.00%
0/7 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
16.7%
1/6 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/9 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
4.0%
1/25 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/7 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
16.7%
1/6 • Number of events 4 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/9 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
4.0%
1/25 • Number of events 4 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/7 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
11.1%
1/9 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/25 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
|
Vascular disorders
Hypertension
|
0.00%
0/7 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
16.7%
1/6 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/9 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
4.0%
1/25 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
|
Vascular disorders
Subclavian artery stenosis
|
0.00%
0/7 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
11.1%
1/9 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/25 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
|
Vascular disorders
Thrombophlebitis
|
14.3%
1/7 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/6 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
0.00%
0/9 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
4.0%
1/25 • Number of events 1 • Up to approximately 297 days
All-cause mortality included all randomized participants. Serious and nonserious AEs included all randomized participants who received at least 1 dose of study treatment. Per protocol, AE reporting was based on study treatment actually received (MK-2214 or placebo) at time of event. MK-2214 Total column reports AEs pooled across Part 1 (Panels A, B, C, and D). Optional Part 2 (Panels E and F) was not conducted.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor will generally support publication of multicenter studies only in their entirety and not as individual site data. In this case, a coordinating investigator will be designated by mutual agreement. 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