Trial Outcomes & Findings for Pharmacodynamics and Efficacy of MK-7288 in Adults With Sleep Apnea (MK-7288-010) (NCT NCT01092780)
NCT ID: NCT01092780
Last Updated: 2018-11-08
Results Overview
Study drug was administered at 08:00. MWT, an objective measure of the participant's ability to maintain wakefulness, was administered at 09:00, 11:00, 13:00 and 15:00. A least squares (LS) mean of the 4 MWTs performed at 09:00, 11:00, 13:00 and 15:00 was calculated. Latency for each MWT is defined as the time to onset of the first 16 continuous seconds of any stage of sleep; if no sleep has been observed according to these rules, then the latency is defined as 30 minutes. A higher MWT value is considered a better outcome.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
56 participants
Primary outcome timeframe
1, 3, 5 and 7 hours post dose
Results posted on
2018-11-08
Participant Flow
Participant milestones
| Measure |
MK-7288 10mg/Pbo/MK-7288 20mg/Modafinil
Participants received single doses of study drug in the following order: MK-7288 10 mg in Treatment Period 1, Placebo (Pbo) in Treatment Period 2, MK-7288 20 mg in Treatment Period 3 and Modafinil 200 mg in Treatment Period 4. The first 3 treatment periods were followed by a 7-day washout period.
|
MK-7288 20mg/MK-7288 10mg/Modafinil/Pbo
Participants received single doses of study drug in the following order: MK-7288 20 mg in Treatment Period 1, MK-7288 10 mg in Treatment Period 2, Modafinil 200 mg in Treatment Period 3 and Placebo in Treatment Period 4. The first 3 treatment periods were followed by a 7-day washout period.
|
Modafinil/MK-7288 20mg/Pbo/MK-7288 10mg
Participants received single doses of study drug in the following order: Modafinil 200 mg in Treatment Period 1, MK-7288 20 mg in Treatment Period 2, Placebo in Treatment Period 3 and MK-7288 10 mg in Treatment Period 4. The first 3 treatment periods were followed by a 7-day washout period.
|
Pbo/Modafinil/MK-7288 10 mg/MK-7288 20mg
Participants received single doses of study drug in the following order: Placebo in Treatment Period 1, Modafinil 200 mg in Treatment Period 2, MK-7288 10 mg in Treatment Period 3 and MK-7288 20 mg in Treatment Period 4. The first 3 treatment periods were followed by a 7-day washout period.
|
|---|---|---|---|---|
|
Treatment Period 1
STARTED
|
14
|
15
|
14
|
13
|
|
Treatment Period 1
COMPLETED
|
14
|
15
|
14
|
13
|
|
Treatment Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout Period 1
STARTED
|
14
|
15
|
14
|
13
|
|
Washout Period 1
COMPLETED
|
13
|
14
|
14
|
13
|
|
Washout Period 1
NOT COMPLETED
|
1
|
1
|
0
|
0
|
|
Treatment Period 2
STARTED
|
13
|
14
|
14
|
13
|
|
Treatment Period 2
COMPLETED
|
13
|
14
|
14
|
13
|
|
Treatment Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout Period 2
STARTED
|
13
|
14
|
14
|
13
|
|
Washout Period 2
COMPLETED
|
13
|
13
|
13
|
13
|
|
Washout Period 2
NOT COMPLETED
|
0
|
1
|
1
|
0
|
|
Treatment Period 3
STARTED
|
13
|
13
|
13
|
13
|
|
Treatment Period 3
COMPLETED
|
13
|
13
|
13
|
13
|
|
Treatment Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout Period 3
STARTED
|
13
|
13
|
13
|
13
|
|
Washout Period 3
COMPLETED
|
13
|
13
|
13
|
13
|
|
Washout Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Treatment Period 4
STARTED
|
13
|
13
|
13
|
13
|
|
Treatment Period 4
COMPLETED
|
13
|
13
|
13
|
13
|
|
Treatment Period 4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
MK-7288 10mg/Pbo/MK-7288 20mg/Modafinil
Participants received single doses of study drug in the following order: MK-7288 10 mg in Treatment Period 1, Placebo (Pbo) in Treatment Period 2, MK-7288 20 mg in Treatment Period 3 and Modafinil 200 mg in Treatment Period 4. The first 3 treatment periods were followed by a 7-day washout period.
|
MK-7288 20mg/MK-7288 10mg/Modafinil/Pbo
Participants received single doses of study drug in the following order: MK-7288 20 mg in Treatment Period 1, MK-7288 10 mg in Treatment Period 2, Modafinil 200 mg in Treatment Period 3 and Placebo in Treatment Period 4. The first 3 treatment periods were followed by a 7-day washout period.
|
Modafinil/MK-7288 20mg/Pbo/MK-7288 10mg
Participants received single doses of study drug in the following order: Modafinil 200 mg in Treatment Period 1, MK-7288 20 mg in Treatment Period 2, Placebo in Treatment Period 3 and MK-7288 10 mg in Treatment Period 4. The first 3 treatment periods were followed by a 7-day washout period.
|
Pbo/Modafinil/MK-7288 10 mg/MK-7288 20mg
Participants received single doses of study drug in the following order: Placebo in Treatment Period 1, Modafinil 200 mg in Treatment Period 2, MK-7288 10 mg in Treatment Period 3 and MK-7288 20 mg in Treatment Period 4. The first 3 treatment periods were followed by a 7-day washout period.
|
|---|---|---|---|---|
|
Washout Period 1
Adverse Event
|
0
|
1
|
0
|
0
|
|
Washout Period 1
Noncompliance with nCPAP
|
1
|
0
|
0
|
0
|
|
Washout Period 2
Adverse Event
|
0
|
1
|
1
|
0
|
Baseline Characteristics
Pharmacodynamics and Efficacy of MK-7288 in Adults With Sleep Apnea (MK-7288-010)
Baseline characteristics by cohort
| Measure |
All Randomized Participants
n=56 Participants
All participants who were randomized in the study.
|
|---|---|
|
Age, Continuous
|
50.0 Years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1, 3, 5 and 7 hours post dosePopulation: The Per-Protocol (PP) population consisted of all participants who were compliant with the protocol and had available data from at least one treatment period.
Study drug was administered at 08:00. MWT, an objective measure of the participant's ability to maintain wakefulness, was administered at 09:00, 11:00, 13:00 and 15:00. A least squares (LS) mean of the 4 MWTs performed at 09:00, 11:00, 13:00 and 15:00 was calculated. Latency for each MWT is defined as the time to onset of the first 16 continuous seconds of any stage of sleep; if no sleep has been observed according to these rules, then the latency is defined as 30 minutes. A higher MWT value is considered a better outcome.
Outcome measures
| Measure |
MK-7288 10 mg
n=54 Participants
Participants received single doses of MK-7288 10 mg.
|
MK-7288 20 mg
n=55 Participants
Participants received single doses of MK-7288 20 mg.
|
Modafinil 200 mg
n=53 Participants
Participants received single doses of Modafinil 200 mg.
|
Placebo
n=52 Participants
Participants received single doses of Placebo.
|
|---|---|---|---|---|
|
Mean Sleep Latency Score on the Maintenance of Wakefulness Test (MWT) for Participants Taking MK-7288 Versus Placebo
|
18.66 Minutes
Interval 16.54 to 20.79
|
18.62 Minutes
Interval 16.5 to 20.73
|
20.71 Minutes
Interval 18.57 to 22.85
|
10.50 Minutes
Interval 8.35 to 12.65
|
PRIMARY outcome
Timeframe: 2, 4 and 6 hours post dosePopulation: The PP population consisted of all participants who were compliant with the protocol and had available data from at least one treatment period.
Study drug was administered at 08:00. Driving performance was measured by the SDLP test which is a 45-minute driving simulation country vigilance test and was performed by participants at 10:00, 12:00 and 14:00. An LS mean of the 2 SDLP driving test results performed at 10:00 and 14:00 was calculated. A lower value is considered a better outcome.
Outcome measures
| Measure |
MK-7288 10 mg
n=54 Participants
Participants received single doses of MK-7288 10 mg.
|
MK-7288 20 mg
n=55 Participants
Participants received single doses of MK-7288 20 mg.
|
Modafinil 200 mg
n=53 Participants
Participants received single doses of Modafinil 200 mg.
|
Placebo
n=52 Participants
Participants received single doses of Placebo.
|
|---|---|---|---|---|
|
Mean Score on Standard Deviation of Lane Position (SDLP) Driving Test for Participants Taking MK-7288 Versus Placebo
|
0.31 Meters
Interval 0.28 to 0.35
|
0.32 Meters
Interval 0.28 to 0.35
|
0.32 Meters
Interval 0.29 to 0.36
|
0.39 Meters
Interval 0.36 to 0.42
|
PRIMARY outcome
Timeframe: Up to 36 daysPopulation: All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.
An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of the study drug, is also an AE.
Outcome measures
| Measure |
MK-7288 10 mg
n=54 Participants
Participants received single doses of MK-7288 10 mg.
|
MK-7288 20 mg
n=55 Participants
Participants received single doses of MK-7288 20 mg.
|
Modafinil 200 mg
n=53 Participants
Participants received single doses of Modafinil 200 mg.
|
Placebo
n=52 Participants
Participants received single doses of Placebo.
|
|---|---|---|---|---|
|
Number of Participants Experiencing Clinical and Laboratory Adverse Events (AEs)
Clinical AE
|
30 Participants
|
37 Participants
|
16 Participants
|
12 Participants
|
|
Number of Participants Experiencing Clinical and Laboratory Adverse Events (AEs)
Laboratory AE
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 1, 3, 5 and 7 hours post dosePopulation: The PP population consisted of all participants who were compliant with the protocol and had available data from at least one treatment period.
Study drug was administered at 08:00. MWT, an objective measure of the participant's ability to maintain wakefulness, was administered at 09:00, 11:00, 13:00 and 15:00. A least squares (LS) mean of the 4 MWTs performed at 09:00, 11:00, 13:00 and 15:00 was calculated. Latency for each MWT is defined as the time to onset of the first 16 continuous seconds of any stage of sleep; if no sleep has been observed according to these rules, then the latency is defined as 30 minutes. A higher MWT value is considered a better outcome.
Outcome measures
| Measure |
MK-7288 10 mg
n=54 Participants
Participants received single doses of MK-7288 10 mg.
|
MK-7288 20 mg
n=55 Participants
Participants received single doses of MK-7288 20 mg.
|
Modafinil 200 mg
n=53 Participants
Participants received single doses of Modafinil 200 mg.
|
Placebo
n=52 Participants
Participants received single doses of Placebo.
|
|---|---|---|---|---|
|
Mean Sleep Latency Score on the MWT for Participants Taking MK-7288 Versus Modafinil
|
18.66 Minutes
Interval 16.54 to 20.79
|
18.62 Minutes
Interval 16.5 to 20.73
|
20.71 Minutes
Interval 18.57 to 22.85
|
10.50 Minutes
Interval 8.35 to 12.65
|
SECONDARY outcome
Timeframe: 1, 3, 5 and 7 hours post dosePopulation: The PP population consisted of all participants who were compliant with the protocol and had available data from at least one treatment period.
Study drug was administered at 08:00. MWT, an objective measure of the participant's ability to maintain wakefulness, was administered at 09:00, 11:00, 13:00 and 15:00. A least squares (LS) mean of the 4 MWTs performed at 09:00, 11:00, 13:00 and 15:00 was calculated. Latency for each MWT is defined as the time to onset of the first 16 continuous seconds of any stage of sleep; if no sleep has been observed according to these rules, then the latency is defined as 30 minutes. A higher MWT value is considered a better outcome.
Outcome measures
| Measure |
MK-7288 10 mg
n=54 Participants
Participants received single doses of MK-7288 10 mg.
|
MK-7288 20 mg
n=55 Participants
Participants received single doses of MK-7288 20 mg.
|
Modafinil 200 mg
n=53 Participants
Participants received single doses of Modafinil 200 mg.
|
Placebo
n=52 Participants
Participants received single doses of Placebo.
|
|---|---|---|---|---|
|
Mean Sleep Latency Score on the MWT for Participants Taking Modafinil Versus Placebo
|
18.66 Minutes
Interval 16.54 to 20.79
|
18.62 Minutes
Interval 16.5 to 20.73
|
20.71 Minutes
Interval 18.57 to 22.85
|
10.50 Minutes
Interval 8.35 to 12.65
|
SECONDARY outcome
Timeframe: 2, 4 and 6 hours post dosePopulation: The PP population consisted of all participants who were compliant with the protocol and had available data from at least one treatment period.
Study drug was administered at 08:00. Driving performance was measured by the SDLP test which is a 45-minute driving simulation country vigilance test and was performed by participants at 10:00, 12:00 and 14:00. An LS mean of the 2 SDLP driving test results performed at 10:00 and 14:00 was calculated. A lower value is considered a better outcome.
Outcome measures
| Measure |
MK-7288 10 mg
n=54 Participants
Participants received single doses of MK-7288 10 mg.
|
MK-7288 20 mg
n=55 Participants
Participants received single doses of MK-7288 20 mg.
|
Modafinil 200 mg
n=53 Participants
Participants received single doses of Modafinil 200 mg.
|
Placebo
n=52 Participants
Participants received single doses of Placebo.
|
|---|---|---|---|---|
|
Mean Score on SDLP Driving Test for Participants Taking Modafinil Versus Placebo
|
0.31 Meters
Interval 0.28 to 0.35
|
0.32 Meters
Interval 0.28 to 0.35
|
0.32 Meters
Interval 0.29 to 0.36
|
0.39 Meters
Interval 0.36 to 0.42
|
Adverse Events
MK-7288 10 mg
Serious events: 1 serious events
Other events: 24 other events
Deaths: 0 deaths
MK-7288 20 mg
Serious events: 1 serious events
Other events: 29 other events
Deaths: 0 deaths
Modafinil 200 mg
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MK-7288 10 mg
n=54 participants at risk
Participants received single doses of MK-7288 10 mg.
|
MK-7288 20 mg
n=55 participants at risk
Participants received single doses of MK-7288 20 mg.
|
Modafinil 200 mg
n=53 participants at risk
Participants received single doses of Modafinil 200 mg.
|
Placebo
n=52 participants at risk
Participants received single doses of Placebo.
|
|---|---|---|---|---|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/54 • Up to 36 days (Up to 3-4 days after last dose of study drug)
The APaT population consisted of all participants who received at least one dose of study drug.
|
1.8%
1/55 • Number of events 1 • Up to 36 days (Up to 3-4 days after last dose of study drug)
The APaT population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/53 • Up to 36 days (Up to 3-4 days after last dose of study drug)
The APaT population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 36 days (Up to 3-4 days after last dose of study drug)
The APaT population consisted of all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/54 • Up to 36 days (Up to 3-4 days after last dose of study drug)
The APaT population consisted of all participants who received at least one dose of study drug.
|
1.8%
1/55 • Number of events 1 • Up to 36 days (Up to 3-4 days after last dose of study drug)
The APaT population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/53 • Up to 36 days (Up to 3-4 days after last dose of study drug)
The APaT population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 36 days (Up to 3-4 days after last dose of study drug)
The APaT population consisted of all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
1.9%
1/54 • Number of events 1 • Up to 36 days (Up to 3-4 days after last dose of study drug)
The APaT population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/55 • Up to 36 days (Up to 3-4 days after last dose of study drug)
The APaT population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/53 • Up to 36 days (Up to 3-4 days after last dose of study drug)
The APaT population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 36 days (Up to 3-4 days after last dose of study drug)
The APaT population consisted of all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/54 • Up to 36 days (Up to 3-4 days after last dose of study drug)
The APaT population consisted of all participants who received at least one dose of study drug.
|
1.8%
1/55 • Number of events 1 • Up to 36 days (Up to 3-4 days after last dose of study drug)
The APaT population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/53 • Up to 36 days (Up to 3-4 days after last dose of study drug)
The APaT population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 36 days (Up to 3-4 days after last dose of study drug)
The APaT population consisted of all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/54 • Up to 36 days (Up to 3-4 days after last dose of study drug)
The APaT population consisted of all participants who received at least one dose of study drug.
|
1.8%
1/55 • Number of events 1 • Up to 36 days (Up to 3-4 days after last dose of study drug)
The APaT population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/53 • Up to 36 days (Up to 3-4 days after last dose of study drug)
The APaT population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 36 days (Up to 3-4 days after last dose of study drug)
The APaT population consisted of all participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
MK-7288 10 mg
n=54 participants at risk
Participants received single doses of MK-7288 10 mg.
|
MK-7288 20 mg
n=55 participants at risk
Participants received single doses of MK-7288 20 mg.
|
Modafinil 200 mg
n=53 participants at risk
Participants received single doses of Modafinil 200 mg.
|
Placebo
n=52 participants at risk
Participants received single doses of Placebo.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/54 • Up to 36 days (Up to 3-4 days after last dose of study drug)
The APaT population consisted of all participants who received at least one dose of study drug.
|
5.5%
3/55 • Number of events 3 • Up to 36 days (Up to 3-4 days after last dose of study drug)
The APaT population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/53 • Up to 36 days (Up to 3-4 days after last dose of study drug)
The APaT population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 36 days (Up to 3-4 days after last dose of study drug)
The APaT population consisted of all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
5.6%
3/54 • Number of events 5 • Up to 36 days (Up to 3-4 days after last dose of study drug)
The APaT population consisted of all participants who received at least one dose of study drug.
|
7.3%
4/55 • Number of events 4 • Up to 36 days (Up to 3-4 days after last dose of study drug)
The APaT population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/53 • Up to 36 days (Up to 3-4 days after last dose of study drug)
The APaT population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 36 days (Up to 3-4 days after last dose of study drug)
The APaT population consisted of all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
3/54 • Number of events 3 • Up to 36 days (Up to 3-4 days after last dose of study drug)
The APaT population consisted of all participants who received at least one dose of study drug.
|
7.3%
4/55 • Number of events 4 • Up to 36 days (Up to 3-4 days after last dose of study drug)
The APaT population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/53 • Up to 36 days (Up to 3-4 days after last dose of study drug)
The APaT population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 36 days (Up to 3-4 days after last dose of study drug)
The APaT population consisted of all participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.6%
3/54 • Number of events 3 • Up to 36 days (Up to 3-4 days after last dose of study drug)
The APaT population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/55 • Up to 36 days (Up to 3-4 days after last dose of study drug)
The APaT population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/53 • Up to 36 days (Up to 3-4 days after last dose of study drug)
The APaT population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 36 days (Up to 3-4 days after last dose of study drug)
The APaT population consisted of all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
1.9%
1/54 • Number of events 1 • Up to 36 days (Up to 3-4 days after last dose of study drug)
The APaT population consisted of all participants who received at least one dose of study drug.
|
10.9%
6/55 • Number of events 7 • Up to 36 days (Up to 3-4 days after last dose of study drug)
The APaT population consisted of all participants who received at least one dose of study drug.
|
1.9%
1/53 • Number of events 1 • Up to 36 days (Up to 3-4 days after last dose of study drug)
The APaT population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 36 days (Up to 3-4 days after last dose of study drug)
The APaT population consisted of all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
1.9%
1/54 • Number of events 1 • Up to 36 days (Up to 3-4 days after last dose of study drug)
The APaT population consisted of all participants who received at least one dose of study drug.
|
5.5%
3/55 • Number of events 3 • Up to 36 days (Up to 3-4 days after last dose of study drug)
The APaT population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/53 • Up to 36 days (Up to 3-4 days after last dose of study drug)
The APaT population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 36 days (Up to 3-4 days after last dose of study drug)
The APaT population consisted of all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
5.6%
3/54 • Number of events 3 • Up to 36 days (Up to 3-4 days after last dose of study drug)
The APaT population consisted of all participants who received at least one dose of study drug.
|
7.3%
4/55 • Number of events 4 • Up to 36 days (Up to 3-4 days after last dose of study drug)
The APaT population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/53 • Up to 36 days (Up to 3-4 days after last dose of study drug)
The APaT population consisted of all participants who received at least one dose of study drug.
|
3.8%
2/52 • Number of events 2 • Up to 36 days (Up to 3-4 days after last dose of study drug)
The APaT population consisted of all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
29.6%
16/54 • Number of events 16 • Up to 36 days (Up to 3-4 days after last dose of study drug)
The APaT population consisted of all participants who received at least one dose of study drug.
|
29.1%
16/55 • Number of events 18 • Up to 36 days (Up to 3-4 days after last dose of study drug)
The APaT population consisted of all participants who received at least one dose of study drug.
|
9.4%
5/53 • Number of events 5 • Up to 36 days (Up to 3-4 days after last dose of study drug)
The APaT population consisted of all participants who received at least one dose of study drug.
|
3.8%
2/52 • Number of events 2 • Up to 36 days (Up to 3-4 days after last dose of study drug)
The APaT population consisted of all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/54 • Up to 36 days (Up to 3-4 days after last dose of study drug)
The APaT population consisted of all participants who received at least one dose of study drug.
|
5.5%
3/55 • Number of events 4 • Up to 36 days (Up to 3-4 days after last dose of study drug)
The APaT population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/53 • Up to 36 days (Up to 3-4 days after last dose of study drug)
The APaT population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 36 days (Up to 3-4 days after last dose of study drug)
The APaT population consisted of all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
5.6%
3/54 • Number of events 3 • Up to 36 days (Up to 3-4 days after last dose of study drug)
The APaT population consisted of all participants who received at least one dose of study drug.
|
1.8%
1/55 • Number of events 1 • Up to 36 days (Up to 3-4 days after last dose of study drug)
The APaT population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/53 • Up to 36 days (Up to 3-4 days after last dose of study drug)
The APaT population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/52 • Up to 36 days (Up to 3-4 days after last dose of study drug)
The APaT population consisted of all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
14.8%
8/54 • Number of events 8 • Up to 36 days (Up to 3-4 days after last dose of study drug)
The APaT population consisted of all participants who received at least one dose of study drug.
|
18.2%
10/55 • Number of events 10 • Up to 36 days (Up to 3-4 days after last dose of study drug)
The APaT population consisted of all participants who received at least one dose of study drug.
|
15.1%
8/53 • Number of events 8 • Up to 36 days (Up to 3-4 days after last dose of study drug)
The APaT population consisted of all participants who received at least one dose of study drug.
|
5.8%
3/52 • Number of events 3 • Up to 36 days (Up to 3-4 days after last dose of study drug)
The APaT population consisted of all participants who received at least one dose of study drug.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation.
- Publication restrictions are in place
Restriction type: OTHER