Trial Outcomes & Findings for A Study to Assess the Efficacy of Gefapixant (MK-7264/AF-219), in Participants With Chronic Cough (MK-7264-006) (NCT NCT01432730)

NCT ID: NCT01432730

Last Updated: 2020-11-24

Results Overview

Daytime Objective Cough Frequency (per hour) is the total number of cough events during the monitoring period (in general, 24-hr interval) the participant is awake divided by the total duration (in hours) for the monitoring period the participants is awake. 24-hour sound recordings were collected using a digital recording device. Change from baseline in awake cough frequency = (post-treatment awake cough frequency - baseline awake cough frequency). A negative result indicates a decrease in cough frequency, while a positive result indicates an increase in cough frequency.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 24 participants
• Primary outcome timeframe: Baseline (Day 0) and Day 14 of each study period
• Results posted on: 2020-11-24

Participant Flow

24 participants were enrolled and randomized from a single center.

Participant milestones

Measure	Gefapixant 600 mg>Placebo Gefapixant, 600 mg, twice daily (BID), taken orally for 2 weeks in Period 1 followed by a 2-week washout period and then placebo, BID, taken orally for 2 weeks in Period 2	Placebo>Gefapixant 600mg Placebo BID, taken orally for 2 weeks in Period 1 followed by a 2-week washout period and then gefapixant, 600 mg, BID, taken orally for 2 weeks in Period 2
Period 1 STARTED	12	12
Period 1 COMPLETED	10	12
Period 1 NOT COMPLETED	2	0
Period 2 STARTED	10	12
Period 2 COMPLETED	10	8
Period 2 NOT COMPLETED	0	4

Reasons for withdrawal

Measure	Gefapixant 600 mg>Placebo Gefapixant, 600 mg, twice daily (BID), taken orally for 2 weeks in Period 1 followed by a 2-week washout period and then placebo, BID, taken orally for 2 weeks in Period 2	Placebo>Gefapixant 600mg Placebo BID, taken orally for 2 weeks in Period 1 followed by a 2-week washout period and then gefapixant, 600 mg, BID, taken orally for 2 weeks in Period 2
Period 1 Adverse Event	2	0
Period 2 Adverse Event	0	4

Baseline Characteristics

A Study to Assess the Efficacy of Gefapixant (MK-7264/AF-219), in Participants With Chronic Cough (MK-7264-006)

Baseline characteristics by cohort

Measure	All Participants n=24 Participants Gefapixant, 600 mg, BID, taken orally for 2 weeks in Period 1 followed by a 2-week washout period and then placebo to gefapixant, BID, taken orally for 2 weeks in Period 2 OR Placebo to gefapixant, BID, taken orally for 2 weeks in Period 1 followed by a 2-week washout period and then gefapixant, 600 mg, BID, taken orally for 2 weeks in Period 2
Age, Continuous	54.5 Years STANDARD_DEVIATION 11.1 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	24 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Day 0) and Day 14 of each study period

Population: Analysis population consisted of all participants for Periods 1 and 2 who were randomized, received at least 1 dose of study drug, were compliant with the study procedure and had available data for this outcome measure.

Daytime Objective Cough Frequency (per hour) is the total number of cough events during the monitoring period (in general, 24-hr interval) the participant is awake divided by the total duration (in hours) for the monitoring period the participants is awake. 24-hour sound recordings were collected using a digital recording device. Change from baseline in awake cough frequency = (post-treatment awake cough frequency - baseline awake cough frequency). A negative result indicates a decrease in cough frequency, while a positive result indicates an increase in cough frequency.

Outcome measures

Measure	Gefapixant 600 mg n=19 Participants Gefapixant 600 mg twice daily (BID) taken orally for 2 weeks	Placebo n=21 Participants Placebo BID taken orally for 2 weeks
Change From Baseline in Daytime Objective Cough Frequency	-0.5365 Coughs/hour Standard Error 0.1718	0.0523 Coughs/hour Standard Error 0.0462

SECONDARY outcome

Timeframe: Baseline (Day 0) and Day 15 of each study period

Population: Analysis population consisted of all participants for Periods 1 and 2 who were randomized, received at least 1 dose of study drug, were compliant with the study procedure and had available data for this outcome measure.

Cough Severity VAS: scored from 0 to 100 using a 10 mm visual analogue scale with 0 at 0mm and 100 at 100mm with 0 representing no cough and 100 the most severe cough. Change from baseline in daytime cough severity = (post-treatment daytime cough severity - baseline daytime cough severity). A negative result indicates a decrease in cough severity, while a positive result indicates an increase in cough severity.

Outcome measures

Measure	Gefapixant 600 mg n=20 Participants Gefapixant 600 mg twice daily (BID) taken orally for 2 weeks	Placebo n=21 Participants Placebo BID taken orally for 2 weeks
Change From Baseline of Daytime Cough Severity Score Using a Visual Analogue Scale (VAS)	-21.5 Score on a scale Standard Deviation 35.65	-0.7 Score on a scale Standard Deviation 19.01

SECONDARY outcome

Timeframe: Baseline (Day 0) and Day 14 of each study period

Population: Analysis population consisted of all participants for Periods 1 and 2 who were randomized, received at least 1 dose of study drug, were compliant with the study procedure and had available data for this outcome measure.

Nighttime Objective Cough Frequency = Total number of cough events during the monitoring period the participant is asleep divided by the total duration (in hours) for the monitoring period the participant is asleep. 24 hour sound recording were collected with a digital recording device. Change from baseline in nighttime cough frequency = (post-treatment nighttime cough frequency - baseline nighttime cough frequency). A negative result indicates a decrease in cough frequency, while a positive result indicates an increase in cough frequency.

Outcome measures

Measure	Gefapixant 600 mg n=18 Participants Gefapixant 600 mg twice daily (BID) taken orally for 2 weeks	Placebo n=20 Participants Placebo BID taken orally for 2 weeks
Change From Baseline in Nighttime Objective Cough Frequency	-0.3452 Coughs/hour Standard Error 0.2314	0.0690 Coughs/hour Standard Error 0.1767

SECONDARY outcome

Timeframe: Baseline (Day 0) and Day 15 of each study period

Population: Analysis population consisted of all participants for Periods 1 and 2 who were randomized, received at least 1 dose of study drug, were compliant with the study procedure and had available data for this outcome measure.

Cough Severity VAS: scored from 0 to 100 using a 10 mm visual analogue scale with 0 at 0mm and 100 at 100mm with 0 representing no cough and 100 the most severe cough. Change from baseline in nighttime cough severity = (post-treatment nighttime cough severity - baseline nighttime cough severity). A negative result indicates a decrease in cough severity, while a positive result indicates an increase in cough severity.

Outcome measures

Measure	Gefapixant 600 mg n=20 Participants Gefapixant 600 mg twice daily (BID) taken orally for 2 weeks	Placebo n=21 Participants Placebo BID taken orally for 2 weeks
Change From Baseline of Nighttime Cough Severity Score Using a Visual Analogue Scale (VAS)	-16.1 Score on a scale Standard Deviation 27.71	-3.7 Score on a scale Standard Deviation 22.05

SECONDARY outcome

Timeframe: 24 hours at Baseline (Day 0) and Day 14 of each study period

Population: Analysis population consisted of all participants for Periods 1 and 2 who were randomized, received at least 1 dose of study drug, were compliant with the study procedure and had available data for this outcome measure.

Total (0-24 hours) Objective Cough Frequency = Total number of cough events during the monitoring period divided by the total duration (in hours, i.e., 24 hours mostly) for the monitoring period. 24-hour sound recordings were collected using a digital recording device. A negative result indicates a decrease in cough frequency, while a positive result indicates an increase in cough frequency.

Outcome measures

Measure	Gefapixant 600 mg n=18 Participants Gefapixant 600 mg twice daily (BID) taken orally for 2 weeks	Placebo n=20 Participants Placebo BID taken orally for 2 weeks
Change From Baseline of 24-hour Objective Cough Frequency	-0.5562 Coughs/hour Standard Error 0.1795	0.0298 Coughs/hour Standard Error 0.0459

SECONDARY outcome

Timeframe: Day 15 of each study period

Population: Analysis population consisted of all participants for Periods 1 and 2 who were randomized, received at least 1 dose of study drug, were compliant with the study procedure and had available data for this outcome measure.

At the end of each study period, participants were asked to complete the global rating of change scale questionnaire. The participants were asked to record whether their cough frequency was "worse", "about the same", or "better". If better or worse, the participants were then asked "by how much" with a 7-category rating scale. Therefore, a 15-point ordered scale was used (1=minimum, a very great deal better to 15=maximum, a very great deal worse with a score of 8=indicating no change).

Outcome measures

Measure	Gefapixant 600 mg n=24 Participants Gefapixant 600 mg twice daily (BID) taken orally for 2 weeks	Placebo n=22 Participants Placebo BID taken orally for 2 weeks
Global Rating of Change Score for Cough Frequency	5.83 Score on a scale Standard Deviation 4.96	8.32 Score on a scale Standard Deviation 2.28

SECONDARY outcome

Timeframe: Day 15 of each study period

Population: Analysis population consisted of all participants for Periods 1 and 2 who were randomized, received at least 1 dose of study drug, were compliant with the study procedure and had available data for this outcome measure.

At the end of each study period, participants were asked to complete the global rating of change scale questionnaire. The participants were asked to record whether their cough severity was "worse", "about the same", or "better". If better or worse, the participants were then asked "by how much" with a 7-category rating scale. Therefore, a 15-point ordered scale was used (1=minimum, a very great deal better to 15=maximum, a very great deal worse with a score of 8=indicating no change).

Outcome measures

Measure	Gefapixant 600 mg n=24 Participants Gefapixant 600 mg twice daily (BID) taken orally for 2 weeks	Placebo n=22 Participants Placebo BID taken orally for 2 weeks
Global Rating of Change Score for Cough Severity	6.00 Score on a scale Standard Deviation 4.94	8.23 Score on a scale Standard Deviation 2.25

SECONDARY outcome

Timeframe: Baseline (Day 0) and Day 15 of each study period

Population: Analysis population consisted of all participants for Periods 1 and 2 who were randomized, received at least 1 dose of study drug, were compliant with the study procedure and had available data for this outcome measure.

The CQLQ Questionnaire included 28 items that described negative aspects of quality of life specific to chronic cough. Subscales include: Physical complaints, Psychosocial issues, Functional abilities, Emotional wellbeing, Extreme physical complaints, and Personal safety fears. Participants indicated their degree of agreement with each statement on a 4 point scale (1 = strongly disagree; 2 = disagree; 3 = agree; 4 = strongly agree). CQLQ scores (28 for least impact, 112 for highest impact) used a mixed effect model with terms for treatment sequence, participant within sequence, treatment, and period. Change from baseline in CQLQ scores = (posttreatment CQLQ scores - baseline CQLQ scores). A negative result indicates a decrease in CQLQ scores (lowest cough impact on health-related quality of life), while a positive result indicates an increase in CQLQ scores (highest cough impact on health-related quality of life).

Outcome measures

Measure	Gefapixant 600 mg n=19 Participants Gefapixant 600 mg twice daily (BID) taken orally for 2 weeks	Placebo n=17 Participants Placebo BID taken orally for 2 weeks
Change From Baseline in Cough-specific Quality of Life Questionnaire (CQLQ)	-10.8 Score on a scale Standard Deviation 14.23	-1.4 Score on a scale Standard Deviation 6.48

SECONDARY outcome

Timeframe: Baseline (Day 0) and Day 15 of each study period

Population: Analysis population consisted of all participants for Periods 1 and 2 who were randomized, received at least 1 dose of study drug, were compliant with the study procedure and had available data for this outcome measure.

UtCQ is determined through the use of a 100mm visual analogue scale (VAS) (ranging between 0 for "no urge to cough" and 100 for "severe urge to cough"). Change from baseline in UtCQ scores = (post-treatment UtCQ scores - baseline UtCQ scores). A negative result indicates a decrease in UtCQ scores (lowest impact), while a positive result indicates an increase in UtCQ scores (highest impact).

Outcome measures

Measure	Gefapixant 600 mg n=24 Participants Gefapixant 600 mg twice daily (BID) taken orally for 2 weeks	Placebo n=20 Participants Placebo BID taken orally for 2 weeks
Change From Baseline in Urge to Cough Questionnaire (UtCQ) 100 mm Visual Analogue Scale	-27.2 Score on a scale Standard Deviation 42.07	-6.5 Score on a scale Standard Deviation 28.59

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (Day 0) of each study period

Population: Analysis population consisted of all participants for Periods 1 and 2 who were randomized, were compliant with the study procedure and had available data at baseline for daytime cough frequency.

Daytime Objective Cough Frequency (per hour) is the total number of cough events during the monitoring period (in general, 24-hr interval) the participant is awake divided by the total duration (in hours) for the monitoring period the participants is awake. 24-hour sound recordings were collected using a digital recording device.

Outcome measures

Measure	Gefapixant 600 mg n=19 Participants Gefapixant 600 mg twice daily (BID) taken orally for 2 weeks	Placebo n=21 Participants Placebo BID taken orally for 2 weeks
Baseline Daytime Cough Frequency	37.09 Coughs/hour Standard Deviation 32.23	65.45 Coughs/hour Standard Deviation 163.36

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (Day 0) of each study period

Population: Analysis population consisted of all participants for Periods 1 and 2 who were randomized, were compliant with the study procedure and had available data at baseline for daytime cough severity.

Cough Severity VAS is scored from 0 to 100 using a 10 mm visual analogue scale with 0 at 0mm and 100 at 100mm with 0 representing no cough and 100 the most severe cough.

Outcome measures

Measure	Gefapixant 600 mg n=20 Participants Gefapixant 600 mg twice daily (BID) taken orally for 2 weeks	Placebo n=21 Participants Placebo BID taken orally for 2 weeks
Baseline Daytime Cough Severity Score Using a Visual Analogue Scale (VAS)	48.8 Score on a scale Standard Deviation 20.73	52.7 Score on a scale Standard Deviation 16.10

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (Day 0) of each study period

Population: Analysis population consisted of all participants for Periods 1 and 2 who were randomized, were compliant with the study procedure and had available data at baseline for nighttime cough frequency.

Nighttime Objective Cough Frequency is the total number of cough events during the monitoring period the participant is asleep divided by the total duration (in hours) for the monitoring period the participant is asleep. 24 hour sound recording were collected with a digital recording device.

Outcome measures

Measure	Gefapixant 600 mg n=18 Participants Gefapixant 600 mg twice daily (BID) taken orally for 2 weeks	Placebo n=20 Participants Placebo BID taken orally for 2 weeks
Baseline Nighttime Objective Cough Frequency	4.34 Coughs/hour Standard Deviation 7.79	7.78 Coughs/hour Standard Deviation 23.80

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (Day 0) of each study period

Population: Analysis population consisted of all participants for Periods 1 and 2 who were randomized, were compliant with the study procedure and had available data at baseline for nighttime cough severity.

Nighttime cough severity was scored from 0 to 100 using a 10 mm visual analogue scale with 0 at 0mm and 100 at 100mm with 0 representing no cough and 100 the most severe cough.

Outcome measures

Measure	Gefapixant 600 mg n=20 Participants Gefapixant 600 mg twice daily (BID) taken orally for 2 weeks	Placebo n=21 Participants Placebo BID taken orally for 2 weeks
Baseline Nighttime Cough Severity Score Using a Visual Analogue Scale (VAS)	31.5 Score on a scale Standard Deviation 23.86	28.8 Score on a scale Standard Deviation 24.88

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (Day 0) of each study period

Population: Analysis population consisted of all participants for Periods 1 and 2 who were randomized, were compliant with the study procedure and had available data at baseline for 24-hour objective cough frequency.

Total (0-24 hours) Objective Cough Frequency = Total number of cough events during the monitoring period divided by the total duration (in hours, i.e., 24 hours mostly) for the monitoring period. 24-hour sound recordings were collected using a digital recording device.

Outcome measures

Measure	Gefapixant 600 mg n=18 Participants Gefapixant 600 mg twice daily (BID) taken orally for 2 weeks	Placebo n=20 Participants Placebo BID taken orally for 2 weeks
Baseline 24-Hour Objective Cough Frequency	26.63 Coughs/hour Standard Deviation 22.63	44.70 Coughs/hour Standard Deviation 105.16

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (Day 0) of each study period

Population: Analysis population consisted of all participants for Periods 1 and 2 who were randomized, were compliant with the study procedure and had available data at baseline for CQLQ.

The CQLQ Questionnaire included 28 items that described negative aspects of quality of life specific to chronic cough. Subscales include: Physical complaints, Psychosocial issues, Functional abilities, Emotional wellbeing, Extreme physical complaints, and Personal safety fears. Participants indicated their degree of agreement with each statement on a 4 point scale (1 = strongly disagree; 2 = disagree; 3 = agree; 4 = strongly agree). CQLQ scores (28 for least impact, 112 for highest impact) used a mixed effect model with terms for treatment sequence, participant within sequence, treatment, and period. Change from baseline in CQLQ scores = (posttreatment CQLQ scores - baseline CQLQ scores). A negative result indicates a decrease in CQLQ scores (lowest cough impact on health-related quality of life), while a positive result indicates an increase in CQLQ scores (highest cough impact on health-related quality of life).

Outcome measures

Measure	Gefapixant 600 mg n=19 Participants Gefapixant 600 mg twice daily (BID) taken orally for 2 weeks	Placebo n=17 Participants Placebo BID taken orally for 2 weeks
Baseline Cough-specific Quality of Life Questionnaire (CQLQ)	56.3 Score on a scale Standard Deviation 10.40	56.2 Score on a scale Standard Deviation 10.28

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (Day 0) of each study period

Population: Analysis population consisted of all participants for Periods 1 and 2 who were randomized, were compliant with the study procedure and had available data at baseline for UtCQ.

UtCQ is determined through the use of a 100mm visual analogue scale (VAS) (ranging between 0 for "no urge to cough" and 100 for "severe urge to cough").

Outcome measures

Measure	Gefapixant 600 mg n=24 Participants Gefapixant 600 mg twice daily (BID) taken orally for 2 weeks	Placebo n=20 Participants Placebo BID taken orally for 2 weeks
Baseline Urge to Cough Questionnaire (UtCQ) 100 mm Visual Analogue Scale	63.1 Score on a scale Standard Deviation 23.10	62.5 Score on a scale Standard Deviation 19.99

Adverse Events

Gefapixant 600 mg

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Gefapixant 600 mg n=24 participants at risk Gefapixant 600 mg twice daily (BID) taken orally for 2 weeks	Placebo n=22 participants at risk Placebo BID taken orally for 2 weeks
Eye disorders Vision blurred	8.3% 2/24 • Number of events 2 • Up to 59 days An adverse event (AE) is any untoward medical occurrence in a study participant administered a study drug that does not necessarily have a causal relationship and is related or not related to the administration of the study drug or treatment.	0.00% 0/22 • Up to 59 days An adverse event (AE) is any untoward medical occurrence in a study participant administered a study drug that does not necessarily have a causal relationship and is related or not related to the administration of the study drug or treatment.
Gastrointestinal disorders Constipation	8.3% 2/24 • Number of events 3 • Up to 59 days An adverse event (AE) is any untoward medical occurrence in a study participant administered a study drug that does not necessarily have a causal relationship and is related or not related to the administration of the study drug or treatment.	0.00% 0/22 • Up to 59 days An adverse event (AE) is any untoward medical occurrence in a study participant administered a study drug that does not necessarily have a causal relationship and is related or not related to the administration of the study drug or treatment.
Gastrointestinal disorders Gastrooesophageal reflux disease	8.3% 2/24 • Number of events 2 • Up to 59 days An adverse event (AE) is any untoward medical occurrence in a study participant administered a study drug that does not necessarily have a causal relationship and is related or not related to the administration of the study drug or treatment.	0.00% 0/22 • Up to 59 days An adverse event (AE) is any untoward medical occurrence in a study participant administered a study drug that does not necessarily have a causal relationship and is related or not related to the administration of the study drug or treatment.
Gastrointestinal disorders Glossodynia	8.3% 2/24 • Number of events 2 • Up to 59 days An adverse event (AE) is any untoward medical occurrence in a study participant administered a study drug that does not necessarily have a causal relationship and is related or not related to the administration of the study drug or treatment.	0.00% 0/22 • Up to 59 days An adverse event (AE) is any untoward medical occurrence in a study participant administered a study drug that does not necessarily have a causal relationship and is related or not related to the administration of the study drug or treatment.
Gastrointestinal disorders Nausea	37.5% 9/24 • Number of events 9 • Up to 59 days An adverse event (AE) is any untoward medical occurrence in a study participant administered a study drug that does not necessarily have a causal relationship and is related or not related to the administration of the study drug or treatment.	4.5% 1/22 • Number of events 1 • Up to 59 days An adverse event (AE) is any untoward medical occurrence in a study participant administered a study drug that does not necessarily have a causal relationship and is related or not related to the administration of the study drug or treatment.
Gastrointestinal disorders Salivary hypersecretion	12.5% 3/24 • Number of events 3 • Up to 59 days An adverse event (AE) is any untoward medical occurrence in a study participant administered a study drug that does not necessarily have a causal relationship and is related or not related to the administration of the study drug or treatment.	4.5% 1/22 • Number of events 1 • Up to 59 days An adverse event (AE) is any untoward medical occurrence in a study participant administered a study drug that does not necessarily have a causal relationship and is related or not related to the administration of the study drug or treatment.
Infections and infestations Nasopharyngitis	4.2% 1/24 • Number of events 1 • Up to 59 days An adverse event (AE) is any untoward medical occurrence in a study participant administered a study drug that does not necessarily have a causal relationship and is related or not related to the administration of the study drug or treatment.	9.1% 2/22 • Number of events 2 • Up to 59 days An adverse event (AE) is any untoward medical occurrence in a study participant administered a study drug that does not necessarily have a causal relationship and is related or not related to the administration of the study drug or treatment.
Nervous system disorders Anosmia	8.3% 2/24 • Number of events 2 • Up to 59 days An adverse event (AE) is any untoward medical occurrence in a study participant administered a study drug that does not necessarily have a causal relationship and is related or not related to the administration of the study drug or treatment.	0.00% 0/22 • Up to 59 days An adverse event (AE) is any untoward medical occurrence in a study participant administered a study drug that does not necessarily have a causal relationship and is related or not related to the administration of the study drug or treatment.
Nervous system disorders Dysgeusia	87.5% 21/24 • Number of events 21 • Up to 59 days An adverse event (AE) is any untoward medical occurrence in a study participant administered a study drug that does not necessarily have a causal relationship and is related or not related to the administration of the study drug or treatment.	0.00% 0/22 • Up to 59 days An adverse event (AE) is any untoward medical occurrence in a study participant administered a study drug that does not necessarily have a causal relationship and is related or not related to the administration of the study drug or treatment.
Nervous system disorders Headache	12.5% 3/24 • Number of events 3 • Up to 59 days An adverse event (AE) is any untoward medical occurrence in a study participant administered a study drug that does not necessarily have a causal relationship and is related or not related to the administration of the study drug or treatment.	4.5% 1/22 • Number of events 2 • Up to 59 days An adverse event (AE) is any untoward medical occurrence in a study participant administered a study drug that does not necessarily have a causal relationship and is related or not related to the administration of the study drug or treatment.
Nervous system disorders Hypogeusia	54.2% 13/24 • Number of events 13 • Up to 59 days An adverse event (AE) is any untoward medical occurrence in a study participant administered a study drug that does not necessarily have a causal relationship and is related or not related to the administration of the study drug or treatment.	0.00% 0/22 • Up to 59 days An adverse event (AE) is any untoward medical occurrence in a study participant administered a study drug that does not necessarily have a causal relationship and is related or not related to the administration of the study drug or treatment.
Psychiatric disorders Depressed mood	8.3% 2/24 • Number of events 2 • Up to 59 days An adverse event (AE) is any untoward medical occurrence in a study participant administered a study drug that does not necessarily have a causal relationship and is related or not related to the administration of the study drug or treatment.	0.00% 0/22 • Up to 59 days An adverse event (AE) is any untoward medical occurrence in a study participant administered a study drug that does not necessarily have a causal relationship and is related or not related to the administration of the study drug or treatment.
Respiratory, thoracic and mediastinal disorders Cough	12.5% 3/24 • Number of events 3 • Up to 59 days An adverse event (AE) is any untoward medical occurrence in a study participant administered a study drug that does not necessarily have a causal relationship and is related or not related to the administration of the study drug or treatment.	4.5% 1/22 • Number of events 1 • Up to 59 days An adverse event (AE) is any untoward medical occurrence in a study participant administered a study drug that does not necessarily have a causal relationship and is related or not related to the administration of the study drug or treatment.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	20.8% 5/24 • Number of events 5 • Up to 59 days An adverse event (AE) is any untoward medical occurrence in a study participant administered a study drug that does not necessarily have a causal relationship and is related or not related to the administration of the study drug or treatment.	4.5% 1/22 • Number of events 1 • Up to 59 days An adverse event (AE) is any untoward medical occurrence in a study participant administered a study drug that does not necessarily have a causal relationship and is related or not related to the administration of the study drug or treatment.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee The data generated in this clinical trial are the property of Sponsor and are confidential. Authorship on any publication or presentation of the results from this study will be govern by the executed Clinical Trial Agreement as well as being consistent with the Uniform Requirements of the International Committee of Medical Journal Editors.
• Publication restrictions are in place

Restriction type: OTHER