Trial Outcomes & Findings for Safety and Tolerability of Gefapixant (MK-7264) in Participants With Obstructive Sleep Apnea (MK-7264-039) (NCT NCT03882801)
NCT ID: NCT03882801
Last Updated: 2024-11-04
Results Overview
The apnea-hypopnea index (AHI) is the sum of the apnea and hypopnea indices for each participant. The apnea index for each participant is calculated as the number of apneas divided by the total sleep time. The hypopnea index for each participant is calculated as the number of hypopneas divided by the total sleep time. These measurements are collected from polysonagraphs (PSGs), which are diagnostic sleep studies that collect electroencephalogram (EEG), electrooculograph (EOG), electromyogram (EMG), electrocardiogram (ECG), airflow, respiratory effort, oximetry, and sleep position data. Baseline AHI measurements in each period are obtained on Day -1. Individual AHI fold-change from baseline in each treatment period are calculated as the ratio of on-treatment AHI to baseline AHI.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
Day-1 at Baseline and Day 7 of each treatment period
Results posted on
2024-11-04
Participant Flow
Participants were enrolled from 3 centers in a single country
24 participants were randomized and enrolled, 23 were administered with at least one dose of study drug, 1 participant was never dosed.
Participant milestones
| Measure |
Placebo Then Gefapixant 180 mg
Placebo once daily at bedtime (QHS) oral for 7 days in Period 1 followed by a 7-day washout period and then Gefapixant, 180 mg, QHS, oral for 7 days in Period 2.
|
Gefapixant 180 mg Then Placebo
Gefapixant, 180 mg, QHS, oral for 7 days in Period 1 followed by a 7-day washout period and then placebo, QHS, oral for 7 days in Period 2.
|
|---|---|---|
|
Period 1
STARTED
|
12
|
12
|
|
Period 1
Treated
|
11
|
12
|
|
Period 1
COMPLETED
|
10
|
10
|
|
Period 1
NOT COMPLETED
|
2
|
2
|
|
Washout Period
STARTED
|
10
|
10
|
|
Washout Period
COMPLETED
|
10
|
9
|
|
Washout Period
NOT COMPLETED
|
0
|
1
|
|
Period 2
STARTED
|
10
|
9
|
|
Period 2
COMPLETED
|
10
|
8
|
|
Period 2
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Placebo Then Gefapixant 180 mg
Placebo once daily at bedtime (QHS) oral for 7 days in Period 1 followed by a 7-day washout period and then Gefapixant, 180 mg, QHS, oral for 7 days in Period 2.
|
Gefapixant 180 mg Then Placebo
Gefapixant, 180 mg, QHS, oral for 7 days in Period 1 followed by a 7-day washout period and then placebo, QHS, oral for 7 days in Period 2.
|
|---|---|---|
|
Period 1
Adverse Event
|
0
|
1
|
|
Period 1
Non-compliance with study drug
|
1
|
1
|
|
Period 1
Never treated with study drug
|
1
|
0
|
|
Washout Period
Physician Decision
|
0
|
1
|
|
Period 2
Non-compliance with study drug
|
0
|
1
|
Baseline Characteristics
Safety and Tolerability of Gefapixant (MK-7264) in Participants With Obstructive Sleep Apnea (MK-7264-039)
Baseline characteristics by cohort
| Measure |
Placebo Then Gefapixant 180 mg
n=12 Participants
Placebo once daily at bedtime (QHS) oral for 7 days in Period 1 followed by a 7-day washout period and then Gefapixant, 180 mg, QHS, oral for 7 days in Period 2.
|
Gefapixant 180 mg Then Placebo
n=12 Participants
Gefapixant, 180 mg, QHS, oral for 7 days in Period 1 followed by a 7-day washout period and then placebo, QHS, oral for 7 days in Period 2.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.7 Years
STANDARD_DEVIATION 7.0 • n=5 Participants
|
56.4 Years
STANDARD_DEVIATION 7.9 • n=7 Participants
|
55.0 Years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day-1 at Baseline and Day 7 of each treatment periodPopulation: Analysis population consisted of all randomized participants who received at least 1 dose of study drug, were compliant with the study procedure and had available data.
The apnea-hypopnea index (AHI) is the sum of the apnea and hypopnea indices for each participant. The apnea index for each participant is calculated as the number of apneas divided by the total sleep time. The hypopnea index for each participant is calculated as the number of hypopneas divided by the total sleep time. These measurements are collected from polysonagraphs (PSGs), which are diagnostic sleep studies that collect electroencephalogram (EEG), electrooculograph (EOG), electromyogram (EMG), electrocardiogram (ECG), airflow, respiratory effort, oximetry, and sleep position data. Baseline AHI measurements in each period are obtained on Day -1. Individual AHI fold-change from baseline in each treatment period are calculated as the ratio of on-treatment AHI to baseline AHI.
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo once daily at bedtime (QHS) taken orally for 7 days
|
Gefapixant 180 mg
n=19 Participants
Gefapixant, 180 mg, QHS, taken orally for 7 days
|
|---|---|---|
|
Apnea-Hypopnea Index (AHI) Change From Baseline as Calculated From Polysonagraphy (PSG)
|
0.86 ratio
Interval 0.68 to 1.09
|
0.97 ratio
Interval 0.74 to 1.27
|
SECONDARY outcome
Timeframe: Up to 14 days after last dose of study drug (Up to 35 days)Population: Any participant who received at least one dose of study drug.
An 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 product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, is also an AE.
Outcome measures
| Measure |
Placebo
n=20 Participants
Placebo once daily at bedtime (QHS) taken orally for 7 days
|
Gefapixant 180 mg
n=22 Participants
Gefapixant, 180 mg, QHS, taken orally for 7 days
|
|---|---|---|
|
Number of Participants Who Experienced an Adverse Event (AE) During the Study
|
2 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Up to 21 daysPopulation: Any participant who received at least 1 dose of study drug
An 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 product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, is also an AE.
Outcome measures
| Measure |
Placebo
n=20 Participants
Placebo once daily at bedtime (QHS) taken orally for 7 days
|
Gefapixant 180 mg
n=22 Participants
Gefapixant, 180 mg, QHS, taken orally for 7 days
|
|---|---|---|
|
Number of Participants Who Discontinued Study Drug Due to an AE
|
0 Participants
|
1 Participants
|
Adverse Events
Screening
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Gefapixant
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Post Trial
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Screening
n=24 participants at risk
Screening
|
Gefapixant
n=22 participants at risk
Gefapixant 180 mg QHS taken orally for 7 days
|
Placebo
n=20 participants at risk
Placebo once daily at bedtime (QHS) taken orally for 7 days
|
Post Trial
n=24 participants at risk
Post trial
|
|---|---|---|---|---|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/24 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/22 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/24 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/24 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
4.5%
1/22 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/24 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/24 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
4.5%
1/22 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/24 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/24 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
9.1%
2/22 • Number of events 3 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/24 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/24 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
13.6%
3/22 • Number of events 3 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/24 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/24 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
4.5%
1/22 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/24 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
|
General disorders
Fatigue
|
0.00%
0/24 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
4.5%
1/22 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/24 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
|
General disorders
Thirst
|
0.00%
0/24 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/22 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/24 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.2%
1/24 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
4.5%
1/22 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/24 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/24 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
4.5%
1/22 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/24 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
|
Investigations
Heart rate increased
|
0.00%
0/24 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
4.5%
1/22 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/24 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
|
Nervous system disorders
Ageusia
|
0.00%
0/24 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
18.2%
4/22 • Number of events 4 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
10.0%
2/20 • Number of events 2 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/24 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/24 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
4.5%
1/22 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/24 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/24 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
4.5%
1/22 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/24 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/24 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
22.7%
5/22 • Number of events 5 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/24 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/24 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
13.6%
3/22 • Number of events 3 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/24 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/24 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
9.1%
2/22 • Number of events 2 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/24 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/24 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
9.1%
2/22 • Number of events 2 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/24 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/24 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
4.5%
1/22 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/24 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/24 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/22 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
5.0%
1/20 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
4.2%
1/24 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
|
Psychiatric disorders
Dysphoria
|
0.00%
0/24 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
4.5%
1/22 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/24 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
|
Social circumstances
Physical assault
|
0.00%
0/24 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
4.5%
1/22 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/24 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
|
General disorders
Feeling abnormal
|
4.2%
1/24 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/22 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/24 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.2%
1/24 • Number of events 1 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/22 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/20 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
0.00%
0/24 • Up to 14 days after last dose of study drug (Up to 35 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated, and/or related with the study drug. Any worsening of a preexisting condition which is temporally associated with the study drug, is also an AE. All-Cause Mortality table includes all randomized participants. Serious Adverse Events and Other Adverse Events tables include all randomized participants who received ≥1 dose of study drug.
|
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 In accordance with standard editorial and ethical practice, 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.
- Publication restrictions are in place
Restriction type: OTHER