Trial Outcomes & Findings for A Dose Escalation Study of Gefapixant (AF-219/MK-7264) in Refractory Chronic Cough (MK-7264-010) (NCT NCT02349425)

Results Overview

Awake Objective 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 participant is awake. 24-hour sound recordings were collected using a digital recording device.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

59 participants

Primary outcome timeframe

Period 1 (while awake): baseline (Day 0) and 24 hours after Day 4, 8, 12 & 16 doses; Period 2 (while awake): baseline (Day 22) and 24 hours after Day 26, 30, 34 and 38 doses

Results posted on

2020-10-22

Participant Flow

Participants were recruited at 12 clinical trial sites in the United States.

29 participants were enrolled, randomized and treated with study drug in Cohort 1 and 30 participants in Cohort 2. Of the 30 participants in Cohort 2, 18 of them were from Cohort 1 and they re-consented, were given new randomization numbers and treated with study drug.

Participant milestones

Participant milestones
Measure	Cohort 1: Gefapixant>Placebo Gefapixant 50, 100, 150, and 200 mg, tablet(s) administered by mouth, twice daily, for 4 days each in Period 1 and placebo to gefapixant 50, 100, 150, and 200 mg, tablet(s) administered by mouth, twice daily, for 4 days each in Period 2. For Cohort 1, there was a 3 to 7 day washout period between treatment periods.	Cohort 1: Placebo>Gefapixant Placebo to gefapixant 50, 100, 150, and 200 mg, tablet(s) administered by mouth, twice daily, for 4 days each in Period 1 and gefapixant 50, 100, 150, and 200 mg, tablet(s) administered by mouth, twice daily, for 4 days each in Period 2. For Cohort 1, there was a 3 to 7 day washout period between treatment periods.	Cohort 2: Gefapixant>Placebo Gefapixant 7.5, 15, 30, and 50 mg, tablet(s) administered by mouth, twice daily, for 4 days each in Period 1 and placebo to gefapixant 7.5, 15, 30, and 50 mg, tablet(s) administered by mouth twice daily for 4 days each in Period 2. For Cohort 2 there was a 14-21 day washout period between treatment periods.	Cohort 2: Placebo>Gefapixant Placebo to gefapixant 7.5, 15, 30, and 50 mg, tablet(s) administered by mouth twice daily for 4 days each in Period 1 and gefapixant 7.5, 15, 30, and 50 mg, tablet(s) administered by mouth, twice daily, for 4 days each in Period 2. For Cohort 2 there was a 14-21 day washout period between treatment periods.
Period 1 STARTED	15	14	15	15
Period 1 COMPLETED	14	13	15	15
Period 1 NOT COMPLETED	1	1	0	0
Period 2 STARTED	14	13	15	15
Period 2 COMPLETED	14	12	14	15
Period 2 NOT COMPLETED	0	1	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1: Gefapixant>Placebo Gefapixant 50, 100, 150, and 200 mg, tablet(s) administered by mouth, twice daily, for 4 days each in Period 1 and placebo to gefapixant 50, 100, 150, and 200 mg, tablet(s) administered by mouth, twice daily, for 4 days each in Period 2. For Cohort 1, there was a 3 to 7 day washout period between treatment periods.	Cohort 1: Placebo>Gefapixant Placebo to gefapixant 50, 100, 150, and 200 mg, tablet(s) administered by mouth, twice daily, for 4 days each in Period 1 and gefapixant 50, 100, 150, and 200 mg, tablet(s) administered by mouth, twice daily, for 4 days each in Period 2. For Cohort 1, there was a 3 to 7 day washout period between treatment periods.	Cohort 2: Gefapixant>Placebo Gefapixant 7.5, 15, 30, and 50 mg, tablet(s) administered by mouth, twice daily, for 4 days each in Period 1 and placebo to gefapixant 7.5, 15, 30, and 50 mg, tablet(s) administered by mouth twice daily for 4 days each in Period 2. For Cohort 2 there was a 14-21 day washout period between treatment periods.	Cohort 2: Placebo>Gefapixant Placebo to gefapixant 7.5, 15, 30, and 50 mg, tablet(s) administered by mouth twice daily for 4 days each in Period 1 and gefapixant 7.5, 15, 30, and 50 mg, tablet(s) administered by mouth, twice daily, for 4 days each in Period 2. For Cohort 2 there was a 14-21 day washout period between treatment periods.
Period 1 Adverse Event	1	1	0	0
Period 2 Adverse Event	0	1	1	0

Baseline Characteristics

A Dose Escalation Study of Gefapixant (AF-219/MK-7264) in Refractory Chronic Cough (MK-7264-010)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1 - Gefapixant>Placebo n=15 Participants Gefapixant 50, 100, 150, and 200 mg, tablet(s) administered by mouth, twice daily, for 4 days each in Period 1 and placebo to gefapixant 50, 100, 150, and 200 mg, tablet(s) administered by mouth, twice daily, for 4 days each in Period 2. For Cohort 1, there was a 3 to 7-day washout period between treatment periods.	Cohort 1 - Placebo>Gefalixant n=14 Participants Placebo to gefapixant 50, 100, 150, and 200 mg, tablet(s) administered by mouth, twice daily, for 4 days each in Period 1 and gefapixant 50, 100, 150, and 200 mg, tablet(s) administered by mouth, twice daily, for 4 days each in Period 2. For Cohort 1, there was a 3 to 7 day washout period between treatment periods.	Cohort 2 - Gefapixant>Placebo n=15 Participants Gefapixant 7.5, 15, 30 and 50 mg, tablet(s) administered by mouth, twice daily, for 4 days each in Period 1 and placebo to gefapixant 7.5, 15, 30 and 50 mg, tablet(s) administered by mouth, twice daily, for 4 days each in Period 2. For Cohort 2, there was a 14 to 21-day washout period between treatment periods.	Cohort 2 - Placebo>Gefapixant n=15 Participants Placebo to gefapixant 7.5, 15, 30 and 50 mg, tablet(s) administered by mouth, twice daily, for 4 days each in Period 1 and gefapixant 7.5, 15, 30 and 50 mg, tablet(s) administered by mouth, twice daily, for 4 days each in Period 2. For Cohort 2, there was a 14 to 21-day washout period between treatment periods.	Total n=59 Participants Total of all reporting groups
Age, Continuous	64.5 Years STANDARD_DEVIATION 6.92 • n=5 Participants	61.7 Years STANDARD_DEVIATION 7.77 • n=7 Participants	60.7 Years STANDARD_DEVIATION 9.42 • n=5 Participants	59.8 Years STANDARD_DEVIATION 12.8 • n=4 Participants	61.7 Years STANDARD_DEVIATION 9.45 • n=21 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	12 Participants n=7 Participants	12 Participants n=5 Participants	12 Participants n=4 Participants	49 Participants n=21 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	10 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=5 Participants	14 Participants n=7 Participants	14 Participants n=5 Participants	14 Participants n=4 Participants	56 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	13 Participants n=7 Participants	13 Participants n=5 Participants	15 Participants n=4 Participants	56 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants

PRIMARY outcome

Timeframe: Period 1 (while awake): baseline (Day 0) and 24 hours after Day 4, 8, 12 & 16 doses; Period 2 (while awake): baseline (Day 22) and 24 hours after Day 26, 30, 34 and 38 doses

Population: Analysis population consisted of all participants in Cohort 1 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.

Awake Objective 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 participant is awake. 24-hour sound recordings were collected using a digital recording device.

Outcome measures

Outcome measures
Measure	Cohort 1 - Gefapixant 50 mg n=26 Participants Gefapixant 50 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 50 mg n=25 Participants Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 100 mg n=24 Participants Gefapixant 100 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 100 mg n=25 Participants Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 150 mg n=23 Participants Gefapixant 150 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 150 mg n=22 Participants Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 200 mg n=25 Participants Gefapixant 200 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 200 mg n=25 Participants Placebo tablet administered by mouth BID for 4 days.
Change in Awake Objective Cough Frequency on Log-transformed Scale - Cohort 1	0.56 Log coughs/hour Interval 0.43 to 0.72	0.95 Log coughs/hour Interval 0.73 to 1.23	0.46 Log coughs/hour Interval 0.34 to 0.61	0.95 Log coughs/hour Interval 0.71 to 1.28	0.48 Log coughs/hour Interval 0.35 to 0.65	0.90 Log coughs/hour Interval 0.65 to 1.24	0.45 Log coughs/hour Interval 0.33 to 0.63	1.06 Log coughs/hour Interval 0.75 to 1.48

PRIMARY outcome

Timeframe: Period 1 (while awake): baseline (Day 0) and 24 hours after Day 4, 8, 12 & 16 doses; Period 2 (while awake): baseline (Day 22) and 24 hours after Day 26, 30, 34 and 38 doses

Population: Analysis population consisted of all participants in Cohort 2 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.

Awake Objective 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 participant is awake. 24-hour sound recordings were collected using a digital recording device.

Outcome measures

Outcome measures
Measure	Cohort 1 - Gefapixant 50 mg n=29 Participants Gefapixant 50 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 50 mg n=28 Participants Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 100 mg n=30 Participants Gefapixant 100 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 100 mg n=29 Participants Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 150 mg n=29 Participants Gefapixant 150 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 150 mg n=29 Participants Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 200 mg n=29 Participants Gefapixant 200 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 200 mg n=27 Participants Placebo tablet administered by mouth BID for 4 days.
Change in Awake Objective Cough Frequency on Log-transformed Scale - Cohort 2	0.80 Log coughs/hour Interval 0.66 to 0.96	0.93 Log coughs/hour Interval 0.77 to 1.13	0.67 Log coughs/hour Interval 0.57 to 0.8	0.90 Log coughs/hour Interval 0.75 to 1.08	0.53 Log coughs/hour Interval 0.4 to 0.69	0.84 Log coughs/hour Interval 0.64 to 1.1	0.44 Log coughs/hour Interval 0.32 to 0.6	1.00 Log coughs/hour Interval 0.72 to 1.38

PRIMARY outcome

Timeframe: Period 1 (while awake): baseline (Day 0) and 24 hours after Day 4, 8, 12 & 16 doses; Period 2 (while awake): baseline (Day 22) and 24 hours after Day 26, 30, 34 and 38 doses

Population: Analysis population consisted of all participants in Cohort 1 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.

Awake 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 participant is awake. 24-hour sound recordings were collected using a digital recording device. Percent Change in Awake Cough Frequency is the change from baseline in awake cough frequency x 100, divided by 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

Outcome measures
Measure	Cohort 1 - Gefapixant 50 mg n=26 Participants Gefapixant 50 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 50 mg n=25 Participants Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 100 mg n=24 Participants Gefapixant 100 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 100 mg n=25 Participants Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 150 mg n=23 Participants Gefapixant 150 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 150 mg n=22 Participants Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 200 mg n=25 Participants Gefapixant 200 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 200 mg n=25 Participants Placebo tablet administered by mouth BID for 4 days.
Percent Change From Baseline in Awake Cough Frequency for Cohort 1	-20.6 Percent Change Standard Deviation 84.29	-0.1 Percent Change Standard Deviation 33.75	-31.7 Percent Change Standard Deviation 70.27	1.9 Percent Change Standard Deviation 35.18	-22.0 Percent Change Standard Deviation 82.84	-0.1 Percent Change Standard Deviation 39.55	-27.9 Percent Change Standard Deviation 57.03	15.1 Percent Change Standard Deviation 48.38

PRIMARY outcome

Timeframe: Period 1 (while awake): baseline (Day 0) and 24 hours after Day 4, 8, 12 & 16 doses; Period 2 (while awake): baseline (Day 22) and 24 hours after Day 26, 30, 34 and 38 doses

Population: Analysis population consisted of all participants in Cohort 2 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.

Awake 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 participant is awake. 24-hour sound recordings were collected using a digital recording device. Percent Change in Awake Cough Frequency is the change from baseline in awake cough frequency x 100, divided by 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

Outcome measures
Measure	Cohort 1 - Gefapixant 50 mg n=29 Participants Gefapixant 50 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 50 mg n=28 Participants Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 100 mg n=30 Participants Gefapixant 100 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 100 mg n=29 Participants Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 150 mg n=29 Participants Gefapixant 150 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 150 mg n=29 Participants Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 200 mg n=29 Participants Gefapixant 200 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 200 mg n=27 Participants Placebo tablet administered by mouth BID for 4 days.
Percent Change From Baseline in Awake Cough Frequency for Cohort 2	5.0 Percent Change Standard Deviation 125.05	-3.8 Percent Change Standard Deviation 36.13	-21.4 Percent Change Standard Deviation 39.32	-6.4 Percent Change Standard Deviation 33.78	-26.3 Percent Change Standard Deviation 61.01	-1.1 Percent Change Standard Deviation 64.38	-28.1 Percent Change Standard Deviation 74.90	23.1 Percent Change Standard Deviation 92.60

PRIMARY outcome

Timeframe: Period 1 (while awake): baseline (Day 0) and 24 hours after Day 4, 8, 12 & 16 doses; Period 2 (while awake): baseline (Day 22) and 24 hours after Day 26, 30, 34 and 38 doses

Population: Analysis population consisted of all participants in Cohort 1 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.

Participants were classified as responders based on the magnitude of the percent change from baseline in Awake Objective cough frequency: 1. ≥70% Reduction=1 if Percent Change from Baseline in cough frequency at the end of the dosing interval ≤-70.0%; 0 Otherwise; 2. ≥50% Reduction=1 if Percent Change from Baseline in cough frequency at the end of the dosing interval ≤ -50.0%; 0 Otherwise; 3. ≥30% Reduction=1 if Percent Change from Baseline in cough frequency at the end of the dosing interval ≤ -30.0%; 0 Otherwise. These responder definitions were not mutually exclusive. A participant who achieved a 1 for ≥70% Reduction for a particular period and dosing interval, were by definition, classified as ≥50% Reduction and ≥ 30% Reduction.

Outcome measures

Outcome measures
Measure	Cohort 1 - Gefapixant 50 mg n=26 Participants Gefapixant 50 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 50 mg n=25 Participants Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 100 mg n=24 Participants Gefapixant 100 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 100 mg n=25 Participants Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 150 mg n=23 Participants Gefapixant 150 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 150 mg n=22 Participants Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 200 mg n=25 Participants Gefapixant 200 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 200 mg n=25 Participants Placebo tablet administered by mouth BID for 4 days.
Responder Analysis of Awake Cough Frequency for Cohort 1 % Reduction ≥70	34.6 Percent Responders	0 Percent Responders	33.3 Percent Responders	0 Percent Responders	34.8 Percent Responders	4.5 Percent Responders	32.0 Percent Responders	0 Percent Responders
Responder Analysis of Awake Cough Frequency for Cohort 1 % Reduction ≥50	46.2 Percent Responders	0 Percent Responders	50.0 Percent Responders	4.0 Percent Responders	47.8 Percent Responders	4.5 Percent Responders	44.0 Percent Responders	0 Percent Responders
Responder Analysis of Awake Cough Frequency for Cohort 1 % Reduction ≥30	53.8 Percent Responders	12.0 Percent Responders	66.7 Percent Responders	16.0 Percent Responders	65.2 Percent Responders	22.7 Percent Responders	56.0 Percent Responders	16.0 Percent Responders

PRIMARY outcome

Timeframe: Period 1 (while awake): baseline (Day 0) and 24 hours after Day 4, 8, 12 & 16 doses; Period 2 (while awake): baseline (Day 22) and 24 hours after Day 26, 30, 34 and 38 doses

Population: Analysis population consisted of all participants in Cohort 2 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.

Participants were classified as responders based on the magnitude of the percent change from baseline in Awake Objective cough frequency: 1. ≥70% Reduction=1 if Percent Change from Baseline in cough frequency at the end of the dosing interval ≤-70.0%; 0 Otherwise; 2. ≥50% Reduction=1 if Percent Change from Baseline in cough frequency at the end of the dosing interval ≤ -50.0%; 0 Otherwise; 3. ≥30% Reduction=1 if Percent Change from Baseline in cough frequency at the end of the dosing interval ≤ -30.0%; 0 Otherwise. These responder definitions were not mutually exclusive. A participant who achieved a 1 for ≥70% Reduction for a particular period and dosing interval, were by definition, classified as ≥50% Reduction and ≥ 30% Reduction.

Outcome measures

Outcome measures
Measure	Cohort 1 - Gefapixant 50 mg n=29 Participants Gefapixant 50 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 50 mg n=28 Participants Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 100 mg n=30 Participants Gefapixant 100 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 100 mg n=29 Participants Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 150 mg n=29 Participants Gefapixant 150 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 150 mg n=29 Participants Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 200 mg n=29 Participants Gefapixant 200 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 200 mg n=27 Participants Placebo tablet administered by mouth BID for 4 days.
Responder Analysis of Awake Cough Frequency for Cohort 2 % Reduction ≥70	3.4 Percent Responders	3.6 Percent Responders	10.0 Percent Responders	0 Percent Responders	20.7 Percent Responders	3.4 Percent Responders	31.0 Percent Responders	3.7 Percent Responders
Responder Analysis of Awake Cough Frequency for Cohort 2 % Reduction ≥50	13.8 Percent Responders	7.1 Percent Responders	20.0 Percent Responders	6.9 Percent Responders	31.0 Percent Responders	17.2 Percent Responders	41.4 Percent Responders	11.1 Percent Responders
Responder Analysis of Awake Cough Frequency for Cohort 2 % Reduction ≥30	37.9 Percent Responders	14.3 Percent Responders	46.7 Percent Responders	20.7 Percent Responders	62.1 Percent Responders	31.0 Percent Responders	55.2 Percent Responders	22.2 Percent Responders

SECONDARY outcome

Timeframe: Period 1 (while awake): baseline (Day 0) and 0-8 hours after Day 4, 8, 12 & 16 doses; Period 2 (while awake): baseline (Day 22) and 0-8 hours after Day 26, 30, 34 and 38 doses

Population: Analysis population consisted of all participants in Cohort 1 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.

Awake (0-8 hours) Objective Cough Frequency is the total number of cough events during the monitoring period the participant was awake for the first 8 hours after the participant took their study medication divided by 8 or the total duration (in hours) for the monitoring period the participant was awake whichever is less. 24-hour sound recordings were collected using a digital recording device. Results are change from baseline: a negative result indicates a decrease in cough frequency, while a positive result indicates an increase in cough frequency. Cough frequency was analyzed using a mixed model repeated measures (MMRM) to evaluate the results of the 2-period cross-over study. The derived change measured at each dose were the repeated measures.

Outcome measures

Outcome measures
Measure	Cohort 1 - Gefapixant 50 mg n=26 Participants Gefapixant 50 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 50 mg n=25 Participants Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 100 mg n=24 Participants Gefapixant 100 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 100 mg n=25 Participants Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 150 mg n=23 Participants Gefapixant 150 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 150 mg n=22 Participants Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 200 mg n=25 Participants Gefapixant 200 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 200 mg n=25 Participants Placebo tablet administered by mouth BID for 4 days.
Change From Baseline in Awake (0-8 Hours) Objective Cough Frequency for Cohort 1	-24.5 Coughs/hour Interval -33.0 to -15.9	-5.5 Coughs/hour Interval -14.2 to 3.3	-24.5 Coughs/hour Interval -33.1 to -15.8	-0.1 Coughs/hour Interval -8.8 to 8.7	-26.5 Coughs/hour Interval -40.3 to -12.8	2.7 Coughs/hour Interval -11.4 to 16.9	-27.5 Coughs/hour Interval -37.9 to -17.0	2.2 Coughs/hour Interval -8.5 to 12.8

SECONDARY outcome

Timeframe: Period 1 (while awake): baseline (Day 0) and 0-8 hours after Day 4, 8, 12 & 16 doses; Period 2 (while awake): baseline (Day 22) and 0-8 hours after Day 26, 30, 34 and 38 doses

Population: Analysis population consisted of all participants in Cohort 2 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.

Awake (0-8 hours) Objective Cough Frequency is the total number of cough events during the monitoring period the participant was awake for the first 8 hours after the participant took their study medication divided by 8 or the total duration (in hours) for the monitoring period the participant was awake whichever is less. 24-hour sound recordings were collected using a digital recording device. Results are change from baseline: a negative result indicates a decrease in cough frequency, while a positive result indicates an increase in cough frequency. Cough frequency was analyzed using a mixed model repeated measures (MMRM) to evaluate the results of the 2-period cross-over study. The derived change measured at each dose were the repeated measures.

Outcome measures

Outcome measures
Measure	Cohort 1 - Gefapixant 50 mg n=29 Participants Gefapixant 50 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 50 mg n=28 Participants Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 100 mg n=30 Participants Gefapixant 100 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 100 mg n=29 Participants Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 150 mg n=29 Participants Gefapixant 150 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 150 mg n=29 Participants Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 200 mg n=29 Participants Gefapixant 200 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 200 mg n=27 Participants Placebo tablet administered by mouth BID for 4 days.
Change From Baseline in Awake (0-8 Hours) Objective Cough Frequency for Cohort 2	-8.0 Coughs/hour Interval -17.9 to 1.9	-1.1 Coughs/hour Interval -11.1 to 9.0	-15.2 Coughs/hour Interval -22.1 to -8.3	-1.7 Coughs/hour Interval -8.8 to 5.3	-21.7 Coughs/hour Interval -31.9 to -11.5	8.5 Coughs/hour Interval -1.8 to 18.8	-21.9 Coughs/hour Interval -32.8 to -11.0	4.7 Coughs/hour Interval -6.5 to 16.0

SECONDARY outcome

Timeframe: Period 1: baseline (Day 0) and 0-24 hours after Day 4, 8, 12 & 16 doses; Period 2: baseline (Day 22) and 0-24 hours after Day 26, 30, 34 and 38 doses

Population: Analysis population consisted of all participants in Cohort 1 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 is the 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. Results are change from baseline: a negative result indicates a decrease in cough frequency, while a positive result indicates an increase in cough frequency. Cough frequency was analyzed using MMRM to evaluate the results of the 2-period cross-over study. The derived change measured at each dose were the repeated measures.

Outcome measures

Outcome measures
Measure	Cohort 1 - Gefapixant 50 mg n=26 Participants Gefapixant 50 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 50 mg n=25 Participants Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 100 mg n=24 Participants Gefapixant 100 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 100 mg n=25 Participants Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 150 mg n=23 Participants Gefapixant 150 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 150 mg n=22 Participants Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 200 mg n=25 Participants Gefapixant 200 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 200 mg n=25 Participants Placebo tablet administered by mouth BID for 4 days.
Change From Baseline in Total (24 Hours) Cough Frequency - Cohort 1	-16.6 Coughs/hour Interval -22.4 to -10.9	-1.5 Coughs/hour Interval -7.5 to 4.5	-17.6 Coughs/hour Interval -24.1 to -11.0	-0.9 Coughs/hour Interval -7.5 to 5.8	-18.0 Coughs/hour Interval -26.1 to -9.9	1.5 Coughs/hour Interval -6.8 to 9.8	-17.4 Coughs/hour Interval -25.2 to -9.5	3.1 Coughs/hour Interval -4.9 to 11.2

SECONDARY outcome

Timeframe: Period 1: baseline (Day 0) and 0-24 hours after Day 4, 8, 12 & 16 doses; Period 2: baseline (Day 22) and 0-24 hours after Day 26, 30, 34 and 38 doses

Population: Analysis population consisted of all participants in Cohort 2 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 is the 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. Results are change from baseline: a negative result indicates a decrease in cough frequency, while a positive result indicates an increase in cough frequency. Cough frequency was analyzed using MMRM to evaluate the results of the 2-period cross-over study. The derived change measured at each dose were the repeated measures.

Outcome measures

Outcome measures
Measure	Cohort 1 - Gefapixant 50 mg n=29 Participants Gefapixant 50 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 50 mg n=28 Participants Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 100 mg n=30 Participants Gefapixant 100 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 100 mg n=29 Participants Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 150 mg n=29 Participants Gefapixant 150 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 150 mg n=29 Participants Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 200 mg n=29 Participants Gefapixant 200 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 200 mg n=27 Participants Placebo tablet administered by mouth BID for 4 days.
Change From Baseline in Total (24 Hours) Cough Frequency - Cohort 2	-6.9 Coughs/hour Interval -12.6 to -1.1	-2.7 Coughs/hour Interval -8.6 to 3.1	-11.0 Coughs/hour Interval -15.5 to -6.4	-3.8 Coughs/hour Interval -8.4 to 0.9	-16.9 Coughs/hour Interval -23.3 to -10.4	1.4 Coughs/hour Interval -5.2 to 7.9	-15.9 Coughs/hour Interval -21.0 to -9.9	1.8 Coughs/hour Interval -4.4 to 7.9

SECONDARY outcome

Timeframe: Period 1 (while asleep): baseline (Day 0) and 24 hours after Day 4, 8, 12 & 16 doses; Period 2 (while asleep): baseline (Day 22) and 24 hours after Day 26, 30, 34 and 38 doses

Population: Analysis population consisted of all participants in Cohort 1 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.

Sleep 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. Results are change from baseline: a negative result indicates a decrease in cough frequency, while a positive result indicates an increase in cough frequency. Cough frequency was analyzed using MMRM to evaluate the results of the 2-period cross-over study. The derived change measured at each dose were the repeated measures.

Outcome measures

Outcome measures
Measure	Cohort 1 - Gefapixant 50 mg n=24 Participants Gefapixant 50 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 50 mg n=24 Participants Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 100 mg n=21 Participants Gefapixant 100 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 100 mg n=24 Participants Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 150 mg n=22 Participants Gefapixant 150 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 150 mg n=22 Participants Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 200 mg n=24 Participants Gefapixant 200 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 200 mg n=25 Participants Placebo tablet administered by mouth BID for 4 days.
Change From Baseline in Sleep Cough Frequency - Cohort 1	-3.5 Coughs/hour Interval -7.0 to 0.1	0.1 Coughs/hour Interval -3.5 to 3.7	-3.1 Coughs/hour Interval -6.8 to 0.6	-0.7 Coughs/hour Interval -4.2 to 2.8	-2.0 Coughs/hour Interval -4.8 to 0.7	-0.1 Coughs/hour Interval -2.8 to 2.6	-3.6 Coughs/hour Interval -7.0 to -0.1	0.2 Coughs/hour Interval -3.2 to 3.6

SECONDARY outcome

Timeframe: Period 1 (while asleep): baseline (Day 0) and 24 hours after Day 4, 8, 12 & 16 doses; Period 2 (while asleep): baseline (Day 22) and 24 hours after Day 26, 30, 34 and 38 doses

Population: Analysis population consisted of all participants in Cohort 2 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.

Sleep 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. Results are change from baseline: a negative result indicates a decrease in cough frequency, while a positive result indicates an increase in cough frequency. Cough frequency was analyzed using MMRM to evaluate the results of the 2-period cross-over study. The derived change measured at each dose were the repeated measures.

Outcome measures

Outcome measures
Measure	Cohort 1 - Gefapixant 50 mg n=29 Participants Gefapixant 50 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 50 mg n=28 Participants Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 100 mg n=30 Participants Gefapixant 100 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 100 mg n=29 Participants Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 150 mg n=29 Participants Gefapixant 150 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 150 mg n=29 Participants Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 200 mg n=28 Participants Gefapixant 200 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 200 mg n=27 Participants Placebo tablet administered by mouth BID for 4 days.
Change From Baseline in Sleep Cough Frequency - Cohort 2	0.6 Coughs/hour Interval -2.7 to 3.9	-0.6 Coughs/hour Interval -3.9 to 2.8	-3.1 Coughs/hour Interval -5.6 to -0.5	-2.5 Coughs/hour Interval -5.1 to 0.2	-2.4 Coughs/hour Interval -4.7 to -0.2	-1.6 Coughs/hour Interval -3.8 to 0.7	-3.0 Coughs/hour Interval -8.7 to 2.6	2.1 Coughs/hour Interval -3.6 to 7.9

SECONDARY outcome

Timeframe: Screening; Period 1: baseline (Day 0) and Days 1-17; Period 2: baseline (Day 22) and Days 23-39

Population: Analysis population consisted of all participants in Cohort 1 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 daily CSD Score is calculated using the daily CSD instrument, a 7-item, disease specific, patient-reported outcome measure with a recall period of "today" (the current day). The measure evaluates frequency of cough (3 items); intensity of cough (2 items); and sleep disruption due to cough (2 items). Each of these 7 items is rated on an 11-point scale, ranging from 0 (best) to 10 (worst), with higher scores indicating greater severity. The total daily CSD score is the sum of these 7 item scores (Min=0, Max=70). Baseline CSD score = average of CSD scores at screening and baseline. Results are change from baseline: a negative result indicates a decrease in cough severity, while a positive result indicates an increase in cough severity. CSD was analyzed using MMRM to evaluate the results of the 2-period cross-over study. The derived change measured at each dose were the repeated measures.

Outcome measures

Outcome measures
Measure	Cohort 1 - Gefapixant 50 mg n=27 Participants Gefapixant 50 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 50 mg n=27 Participants Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 100 mg n=26 Participants Gefapixant 100 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 100 mg n=27 Participants Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 150 mg n=26 Participants Gefapixant 150 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 150 mg n=27 Participants Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 200 mg n=28 Participants Gefapixant 200 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 200 mg n=28 Participants Placebo tablet administered by mouth BID for 4 days.
Change From Baseline of the Mean Total Daily Cough Severity Diary (CSD) Score for Cohort 1	-0.6 Score on a scale Interval -1.2 to -0.1	0.0 Score on a scale Interval -0.5 to 0.5	-1.1 Score on a scale Interval -1.8 to -0.5	0.1 Score on a scale Interval -0.5 to 0.8	-1.5 Score on a scale Interval -2.2 to -0.8	0.1 Score on a scale Interval -0.6 to 0.8	-1.6 Score on a scale Interval -2.4 to -0.8	0.1 Score on a scale Interval -0.7 to 0.9

SECONDARY outcome

Timeframe: Screening; Period 1: baseline (Day 0) and Days 1-17; Period 2: baseline (Day 22) and Days 23-39

Population: Analysis population consisted of all participants in Cohort 2 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 daily CSD Score is calculated using the daily CSD instrument, a 7-item, disease specific, patient-reported outcome measure with a recall period of "today" (the current day). The measure evaluates frequency of cough (3 items); intensity of cough (2 items); and sleep disruption due to cough (2 items). Each of these 7 items is rated on an 11-point scale, ranging from 0 (best) to 10 (worst), with higher scores indicating greater severity. The total daily CSD score is the sum of these 7 item scores (Min=0, Max=70). Baseline CSD score = average of CSD scores at screening and baseline. Results are change from baseline: a negative result indicates a decrease in cough severity, while a positive result indicates an increase in cough severity. CSD was analyzed using MMRM to evaluate the results of the 2-period cross-over study. The derived change measured at each dose were the repeated measures.

Outcome measures

Outcome measures
Measure	Cohort 1 - Gefapixant 50 mg n=30 Participants Gefapixant 50 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 50 mg n=29 Participants Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 100 mg n=30 Participants Gefapixant 100 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 100 mg n=29 Participants Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 150 mg n=30 Participants Gefapixant 150 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 150 mg n=29 Participants Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 200 mg n=29 Participants Gefapixant 200 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 200 mg n=29 Participants Placebo tablet administered by mouth BID for 4 days.
Change From Baseline of the Mean Total Daily Cough Severity Diary (CSD) Score for Cohort 2	-1.0 Score on a scale Interval -1.5 to -0.5	-0.3 Score on a scale Interval -0.8 to 0.2	-1.2 Score on a scale Interval -1.8 to -0.6	-0.3 Score on a scale Interval -0.9 to 0.3	-1.7 Score on a scale Interval -2.3 to -1.1	-0.3 Score on a scale Interval -1.0 to 0.3	-1.6 Score on a scale Interval -2.4 to -0.9	-0.5 Score on a scale Interval -1.3 to 0.2

SECONDARY outcome

Timeframe: Period 1: Day 0 (baseline) and Day 17; Period 2: Day 22 (baseline) and Day 39

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

The LCQ-Acute is a 19-item health-related quality-of-life (HRQoL) questionnaire specific for acute cough which contains three domains (i.e., physical, psychological, and social). It is calculated as a mean score for each domain ranging from 1 (worst) to 7 (best), and total score ranging from 3 (worst) to 21 (best). Each item on the LCQ-acute assesses symptoms or the impact of symptoms on HRQoL in the last 24 hours using a 7-point Likert scale ranging from 1 to 7. Higher scores indicate better HRQoL. Participants' perception of their cough severity was assessed, based on the LCQ-Acute score, at Baseline and last day of dose. LCQ was analyzed using MMRM to evaluate the results of the 2-period cross-over study. The derived change measured at each dose were the repeated measures.

Outcome measures

Outcome measures
Measure	Cohort 1 - Gefapixant 50 mg n=27 Participants Gefapixant 50 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 50 mg n=28 Participants Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 100 mg n=30 Participants Gefapixant 100 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 100 mg n=29 Participants Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 150 mg Gefapixant 150 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 150 mg Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 200 mg Gefapixant 200 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 200 mg Placebo tablet administered by mouth BID for 4 days.
Change From Baseline at End of Treatment Period Leicester Cough Questionnaire (LCQ): Individual Domain and Total Scores for Cohort 1 and 2	3.02 Score on a scale Interval 1.61 to 4.42	-0.82 Score on a scale Interval -2.19 to 0.55	3.57 Score on a scale Interval 2.27 to 4.87	0.05 Score on a scale Interval -1.28 to 1.37	—	—	—	—

SECONDARY outcome

Timeframe: Screening; Period 1: baseline (Day 0) and Day 4, 8, 12 & 16; Period 2: baseline (Day 22) and Day 26, 30, 34, 38 and 39

Population: Analysis population consisted of all participants in Cohort 1 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 VAS is scored from 0 to 100 using a 10 mm visual analogue scale with 0 at 0mm and 100 at 10mm with 0 (no cough) and 100 (most severe cough). Baseline cough VAS is defined as average of screening and baseline cough VAS. Results are change from baseline: a negative result indicates a decrease in cough severity, while a positive result indicates an increase in cough severity. Cough VAS was analyzed using MMRM to evaluate the results of the 2-period cross-over study. The derived change measured at each dose were the repeated measures.

Outcome measures

Outcome measures
Measure	Cohort 1 - Gefapixant 50 mg n=27 Participants Gefapixant 50 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 50 mg n=28 Participants Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 100 mg n=27 Participants Gefapixant 100 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 100 mg n=27 Participants Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 150 mg n=26 Participants Gefapixant 150 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 150 mg n=27 Participants Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 200 mg n=26 Participants Gefapixant 200 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 200 mg n=27 Participants Placebo tablet administered by mouth BID for 4 days.
Change From Baseline of Cough Visual Analogue Scale (VAS) Score for Cohort 1	-14.4 Score on a scale Interval -23.4 to -5.5	-3.8 Score on a scale Interval -12.6 to 5.0	-26.3 Score on a scale Interval -36.0 to -16.6	-6.3 Score on a scale Interval -15.9 to 3.2	-28.8 Score on a scale Interval -39.1 to -18.4	-2.6 Score on a scale Interval -12.8 to 7.6	-31.5 Score on a scale Interval -41.9 to -21.0	2.3 Score on a scale Interval -8.0 to 12.6

SECONDARY outcome

Timeframe: Screening; Period 1: baseline (Day 0) and Day 4, 8, 12 & 16; Period 2: baseline (Day 22) and Day 26, 30, 34, 38 and 39

Population: Analysis population consisted of all participants in Cohort 2 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 VAS is scored from 0 to 100 using a 10 mm visual analogue scale with 0 at 0mm and 100 at 10mm with 0 (no cough) and 100 (most severe cough). Baseline cough VAS is defined as average of screening and baseline cough VAS. Results are change from baseline: a negative result indicates a decrease in cough severity, while a positive result indicates an increase in cough severity. Cough VAS was analyzed using MMRM to evaluate the results of the 2-period cross-over study. The derived change measured at each dose were the repeated measures.

Outcome measures

Outcome measures
Measure	Cohort 1 - Gefapixant 50 mg n=30 Participants Gefapixant 50 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 50 mg n=29 Participants Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 100 mg n=30 Participants Gefapixant 100 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 100 mg n=29 Participants Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 150 mg n=30 Participants Gefapixant 150 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 150 mg n=29 Participants Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 200 mg n=29 Participants Gefapixant 200 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 200 mg n=29 Participants Placebo tablet administered by mouth BID for 4 days.
Change From Baseline of Cough Visual Analogue Scale (VAS) Score for Cohort 2	-12.6 Score on a scale Interval -21.5 to -3.8	-6.2 Score on a scale Interval -15.2 to 2.9	-17.4 Score on a scale Interval -26.0 to -8.7	-10.0 Score on a scale Interval -18.7 to -1.2	-23.3 Score on a scale Interval -31.7 to -14.9	-7.7 Score on a scale Interval -16.2 to 0.9	-24.7 Score on a scale Interval -35.2 to -14.2	-9.3 Score on a scale Interval -19.9 to 1.4

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 hours (while awake) on Days 0 and 22 (Baseline)

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

Awake 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 participant is awake. 24 hour sound recordings were collected using a digital recording device. Baseline measurements were not available by individual arm because baseline cough frequencies were measured before participants received the first dose of study drug. Baseline summaries were evaluated based on the participant's randomized group (gefapixant or placebo).

Outcome measures

Outcome measures
Measure	Cohort 1 - Gefapixant 50 mg n=28 Participants Gefapixant 50 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 50 mg n=26 Participants Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 100 mg n=30 Participants Gefapixant 100 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 100 mg n=29 Participants Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 150 mg Gefapixant 150 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 150 mg Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 200 mg Gefapixant 200 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 200 mg Placebo tablet administered by mouth BID for 4 days.
Baseline (Predose) Awake Objective Cough Frequency for Cohort 1 and Cohort 2	54.5 Coughs/hour Standard Deviation 41.09	52.8 Coughs/hour Standard Deviation 40.44	49.6 Coughs/hour Standard Deviation 44.01	46.1 Coughs/hour Standard Deviation 39.82	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: First 8 hours (while awake) on Days 0 and 22 (Baseline)

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

Awake (0 - 8 hours) Objective Cough Frequency is the total number of cough events during the monitoring period the participant was awake for the first 8 hours after the participant took their study medication divided by 8 or the total duration (in hours) for the monitoring period the participant was awake whichever is less. 24 hour sound recordings were collected with a digital recording device. Baseline measurements were not available by individual arm because baseline cough frequencies were measured before participants received the first dose of study drug. Baseline summaries were evaluated based on the participant's randomized group (gefapixant or placebo).

Outcome measures

Outcome measures
Measure	Cohort 1 - Gefapixant 50 mg n=28 Participants Gefapixant 50 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 50 mg n=26 Participants Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 100 mg n=30 Participants Gefapixant 100 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 100 mg n=29 Participants Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 150 mg Gefapixant 150 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 150 mg Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 200 mg Gefapixant 200 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 200 mg Placebo tablet administered by mouth BID for 4 days.
Baseline (Predose) Awake (0 - 8 Hours) Cough Frequency for Cohort 1 and Cohort 2	51.8 Coughs/hour Standard Deviation 41.09	53.3 Coughs/hour Standard Deviation 42.30	47.2 Coughs/hour Standard Deviation 42.09	42.2 Coughs/hour Standard Deviation 39.42	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 hours (while awake) on Days 0 and 22 (Baseline)

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

Total (0 - 24 hours) Objective Cough Frequency is the total number of cough events during the monitoring period divided by the total duration (in hours) for the monitoring period. 24 hour sound recordings were collected using a digital recording device. Baseline measurements were not available by individual arm because baseline cough frequencies were measured before participants received the first dose of study drug. Baseline summaries were evaluated based on the participant's randomized group (gefapixant or placebo).

Outcome measures

Outcome measures
Measure	Cohort 1 - Gefapixant 50 mg n=28 Participants Gefapixant 50 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 50 mg n=26 Participants Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 100 mg n=30 Participants Gefapixant 100 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 100 mg n=29 Participants Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 150 mg Gefapixant 150 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 150 mg Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 200 mg Gefapixant 200 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 200 mg Placebo tablet administered by mouth BID for 4 days.
Baseline (Predose) Total (24-hour) Cough Frequency for Cohort 1 and Cohort 2	39.7 Coughs/hour Standard Deviation 28.38	37.9 Coughs/hour Standard Deviation 27.46	36.3 Coughs/hour Standard Deviation 32.28	32.2 Coughs/hour Standard Deviation 27.97	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: First 8 hours (while asleep) on Days 0 and 22 (Baseline)

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

Sleep 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. Baseline measurements were not available by individual arm because baseline cough frequencies were measured before participants received the first dose of study drug. Baseline summaries were evaluated based on the participant's randomized group (gefapixant or placebo).

Outcome measures

Outcome measures
Measure	Cohort 1 - Gefapixant 50 mg n=27 Participants Gefapixant 50 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 50 mg n=26 Participants Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 100 mg n=30 Participants Gefapixant 100 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 100 mg n=29 Participants Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 150 mg Gefapixant 150 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 150 mg Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 200 mg Gefapixant 200 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 200 mg Placebo tablet administered by mouth BID for 4 days.
Baseline (Predose) for Sleep Cough Frequency for Cohort 1 and Cohort 2	8.3 Coughs/hour Standard Deviation 9.30	7.8 Coughs/hour Standard Deviation 9.80	10.1 Coughs/hour Standard Deviation 26.77	5.6 Coughs/hour Standard Deviation 7.58	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (Days 0 and 22)

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

The daily CSD Score is calculated using the daily CSD instrument, a 7-item, disease specific, patient-reported outcome measure with a recall period of "today" (the current day). The measure evaluates frequency of cough (3 items); intensity of cough (2 items); and sleep disruption due to cough (2 items). Each of these 7 items is rated on an 11-point scale, ranging from 0 (best) to 10 (worst), with higher scores indicating greater severity. The total daily CSD score is the sum of these 7 item scores (Min=0, Max=70). Baseline CSD score = average of CSD scores at screening and baseline. A negative result indicates a decrease in cough frequency, while a positive result indicates an increase in cough frequency. Baseline measurements were not available by individual arm because baseline cough frequencies were measured before participants received the first dose of study drug. Baseline summaries were evaluated based on the participant's randomized group (gefapixant or placebo).

Outcome measures

Outcome measures
Measure	Cohort 1 - Gefapixant 50 mg n=28 Participants Gefapixant 50 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 50 mg n=28 Participants Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 100 mg n=30 Participants Gefapixant 100 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 100 mg n=28 Participants Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 150 mg Gefapixant 150 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 150 mg Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 200 mg Gefapixant 200 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 200 mg Placebo tablet administered by mouth BID for 4 days.
Baseline (Predose) for the Mean Total Daily Cough Severity Diary (CSD) Score for Cohort 1 and Cohort 2	4.2 Score on a scale Standard Deviation 1.89	3.7 Score on a scale Standard Deviation 1.61	4.5 Score on a scale Standard Deviation 1.98	4.5 Score on a scale Standard Deviation 1.93	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Days 0 and 22 (Baseline)

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

The LCQ-Acute is a 19-item health-related quality-of-life (HRQoL) questionnaire specific for acute cough which contains three domains (i.e., physical, psychological, and social). It is calculated as a mean score for each domain ranging from 1 (worst) to 7 (best), and total score ranging from 3 (worst) to 21 (best). Each item on the LCQ-acute assesses symptoms or the impact of symptoms on HRQoL in the last 24 hours using a 7-point Likert scale ranging from 1 to 7. Higher scores indicate better HRQoL. As per the Statistical Analysis Plan, each domain and total LCQ score change from baseline were analyzed without the treatment by dose interaction. Baseline summaries were evaluated based on the participant's randomized group (gefapixant or placebo).

Outcome measures

Outcome measures
Measure	Cohort 1 - Gefapixant 50 mg n=28 Participants Gefapixant 50 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 50 mg n=28 Participants Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 100 mg n=30 Participants Gefapixant 100 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 100 mg n=29 Participants Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 150 mg Gefapixant 150 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 150 mg Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 200 mg Gefapixant 200 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 200 mg Placebo tablet administered by mouth BID for 4 days.
Baseline (Predose) for the Acute Leicester Cough Questionnaire (LCQ) Instrument for Cohort 1 and Cohort 2 Psychological Domain Score	3.8 Score on a scale Standard Deviation 1.21	4.1 Score on a scale Standard Deviation 1.45	3.9 Score on a scale Standard Deviation 1.57	4.1 Score on a scale Standard Deviation 1.56	—	—	—	—
Baseline (Predose) for the Acute Leicester Cough Questionnaire (LCQ) Instrument for Cohort 1 and Cohort 2 Physical Domain Score	4.4 Score on a scale Standard Deviation 0.99	4.7 Score on a scale Standard Deviation 1.06	4.8 Score on a scale Standard Deviation 1.19	5.0 Score on a scale Standard Deviation 1.00	—	—	—	—
Baseline (Predose) for the Acute Leicester Cough Questionnaire (LCQ) Instrument for Cohort 1 and Cohort 2 Social Domain Score	4.2 Score on a scale Standard Deviation 1.22	4.3 Score on a scale Standard Deviation 1.21	3.9 Score on a scale Standard Deviation 1.57	4.2 Score on a scale Standard Deviation 1.57	—	—	—	—
Baseline (Predose) for the Acute Leicester Cough Questionnaire (LCQ) Instrument for Cohort 1 and Cohort 2 Total Acute Leicester Score	12.3 Score on a scale Standard Deviation 3.13	13.1 Score on a scale Standard Deviation 3.41	12.6 Score on a scale Standard Deviation 4.04	13.3 Score on a scale Standard Deviation 3.81	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Screening, Days 0 and 22 (Baseline)

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

Cough VAS: scored from 0 to 100 using a 10 mm visual analogue scale with 0 (no cough) and 100 (most severe cough) mm. Baseline cough VAS is defined as average of screening and baseline cough VAS. Baseline measurements were not available by individual arm because baseline cough frequencies were measured before participants received the first dose of study drug. Baseline summaries were evaluated based on the participant's randomized group (gefapixant or placebo).

Outcome measures

Outcome measures
Measure	Cohort 1 - Gefapixant 50 mg n=28 Participants Gefapixant 50 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 50 mg n=28 Participants Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 100 mg n=30 Participants Gefapixant 100 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 100 mg n=29 Participants Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 150 mg Gefapixant 150 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 150 mg Placebo tablet administered by mouth BID for 4 days.	Cohort 1 - Gefapixant 200 mg Gefapixant 200 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo for Gefapixant 200 mg Placebo tablet administered by mouth BID for 4 days.
Baseline (Predose) for Cough Visual Analogue Scale (VAS) for Cohort 1 and Cohort 2	58.4 Score on a scale Standard Deviation 18.66	52.2 Score on a scale Standard Deviation 19.21	54.5 Score on a scale Standard Deviation 24.26	57.2 Score on a scale Standard Deviation 23.71	—	—	—	—

Adverse Events

Cohort 1: Gefapixant 50 mg

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Cohort 1: Gefapixant 100 mg

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Cohort 1 - Gefapixant 150 mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Cohort 1: Gefapixant 200 mg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Cohort 1 - Placebo

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Cohort 2 - Gefapixant 7.5 mg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Cohort 2 - Gefapixant 15 mg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Cohort 2 - Gefapixant 30 mg

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Cohort 2 - Gefapixant 50 mg

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Cohort 2- Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1: Gefapixant 50 mg n=28 participants at risk Gefapixant 50 mg tablet administered by mouth twice daily (BID) for 4 days.	Cohort 1: Gefapixant 100 mg n=28 participants at risk Gefapixant 100 mg tablet administered by mouth BID or 4 days.	Cohort 1 - Gefapixant 150 mg n=26 participants at risk Gefapixant 150 mg tablet administered by mouth BID for 4 days.	Cohort 1: Gefapixant 200 mg n=26 participants at risk Gefapixant 200 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo n=28 participants at risk Placebo tablet administered by mouth BID for 4 days each.	Cohort 2 - Gefapixant 7.5 mg n=30 participants at risk Gefapixant 7.5 mg tablet administered by mouth BID for 4 days.	Cohort 2 - Gefapixant 15 mg n=30 participants at risk Gefapixant 15 mg tablet administered by mouth BID for 4 days.	Cohort 2 - Gefapixant 30 mg n=30 participants at risk Gefapixant 30 mg tablet administered by mouth BID for 4 days.	Cohort 2 - Gefapixant 50 mg n=30 participants at risk Gefapixant 50 mg tablet administered by mouth BID for 4 days.	Cohort 2- Placebo n=29 participants at risk Placebo tablet administered by mouth BID for 4 days each.
Metabolism and nutrition disorders Dehydration	0.00% 0/28 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	3.6% 1/28 • Number of events 1 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/26 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/26 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/28 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/30 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/30 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/30 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/30 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/29 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug
Investigations Blood creatinine increased	0.00% 0/28 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	3.6% 1/28 • Number of events 1 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/26 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/26 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/28 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/30 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/30 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/30 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/30 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/29 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.00% 0/28 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/28 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/26 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/26 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	3.6% 1/28 • Number of events 1 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/30 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/30 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/30 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/30 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/29 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug
Nervous system disorders Cerebrovascular accident	0.00% 0/28 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/28 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/26 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/26 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/28 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/30 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/30 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/30 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	3.3% 1/30 • Number of events 1 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/29 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug
Nervous system disorders Presyncope	0.00% 0/28 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	3.6% 1/28 • Number of events 1 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/26 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/26 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/28 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/30 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/30 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/30 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/30 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/29 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug

Other adverse events

Other adverse events
Measure	Cohort 1: Gefapixant 50 mg n=28 participants at risk Gefapixant 50 mg tablet administered by mouth twice daily (BID) for 4 days.	Cohort 1: Gefapixant 100 mg n=28 participants at risk Gefapixant 100 mg tablet administered by mouth BID or 4 days.	Cohort 1 - Gefapixant 150 mg n=26 participants at risk Gefapixant 150 mg tablet administered by mouth BID for 4 days.	Cohort 1: Gefapixant 200 mg n=26 participants at risk Gefapixant 200 mg tablet administered by mouth BID for 4 days.	Cohort 1 - Placebo n=28 participants at risk Placebo tablet administered by mouth BID for 4 days each.	Cohort 2 - Gefapixant 7.5 mg n=30 participants at risk Gefapixant 7.5 mg tablet administered by mouth BID for 4 days.	Cohort 2 - Gefapixant 15 mg n=30 participants at risk Gefapixant 15 mg tablet administered by mouth BID for 4 days.	Cohort 2 - Gefapixant 30 mg n=30 participants at risk Gefapixant 30 mg tablet administered by mouth BID for 4 days.	Cohort 2 - Gefapixant 50 mg n=30 participants at risk Gefapixant 50 mg tablet administered by mouth BID for 4 days.	Cohort 2- Placebo n=29 participants at risk Placebo tablet administered by mouth BID for 4 days each.
Gastrointestinal disorders Dry mouth	3.6% 1/28 • Number of events 1 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/28 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/26 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/26 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/28 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/30 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/30 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	3.3% 1/30 • Number of events 1 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/30 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	6.9% 2/29 • Number of events 2 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug
Gastrointestinal disorders Hypoaesthesia oral	3.6% 1/28 • Number of events 1 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	7.1% 2/28 • Number of events 2 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/26 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	3.8% 1/26 • Number of events 1 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/28 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/30 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/30 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	3.3% 1/30 • Number of events 1 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/30 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/29 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug
Gastrointestinal disorders Paraesthesia oral	7.1% 2/28 • Number of events 2 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	3.6% 1/28 • Number of events 1 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/26 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	3.8% 1/26 • Number of events 1 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/28 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/30 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/30 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	6.7% 2/30 • Number of events 2 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	3.3% 1/30 • Number of events 1 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/29 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug
Infections and infestations Rhinitis	0.00% 0/28 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/28 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/26 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/26 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	3.6% 1/28 • Number of events 1 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	6.7% 2/30 • Number of events 2 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/30 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/30 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/30 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/29 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug
Infections and infestations Upper respiratory tract infection	0.00% 0/28 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/28 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/26 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/26 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	3.6% 1/28 • Number of events 1 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/30 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/30 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/30 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	13.3% 4/30 • Number of events 4 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/29 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug
Infections and infestations Viral upper respiratory tract infection	0.00% 0/28 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/28 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/26 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/26 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	7.1% 2/28 • Number of events 2 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/30 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/30 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/30 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/30 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/29 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug
Investigations Urine output decreased	7.1% 2/28 • Number of events 3 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/28 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/26 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/26 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/28 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/30 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/30 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/30 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/30 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/29 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug
Musculoskeletal and connective tissue disorders Flank pain	3.6% 1/28 • Number of events 1 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/28 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/26 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	7.7% 2/26 • Number of events 2 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/28 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/30 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/30 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/30 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/30 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/29 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug
Nervous system disorders Ageusia	7.1% 2/28 • Number of events 2 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/28 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/26 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	3.8% 1/26 • Number of events 1 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/28 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/30 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/30 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/30 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	6.7% 2/30 • Number of events 2 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/29 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug
Nervous system disorders Dysgeusia	46.4% 13/28 • Number of events 13 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	21.4% 6/28 • Number of events 6 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	15.4% 4/26 • Number of events 4 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	3.8% 1/26 • Number of events 1 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	3.6% 1/28 • Number of events 1 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	6.7% 2/30 • Number of events 2 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	3.3% 1/30 • Number of events 1 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	40.0% 12/30 • Number of events 12 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	13.3% 4/30 • Number of events 4 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/29 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug
Nervous system disorders Hypogeusia	7.1% 2/28 • Number of events 2 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	7.1% 2/28 • Number of events 2 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/26 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/26 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/28 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/30 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/30 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/30 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/30 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/29 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug
Respiratory, thoracic and mediastinal disorders Nasal dryness	0.00% 0/28 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/28 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/26 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/26 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/28 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	6.7% 2/30 • Number of events 2 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/30 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/30 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/30 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug	0.00% 0/29 • Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks Analysis population consisted of all randomized participants who received at least 1 dose of study drug

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee No data collected as part of this study will be utilized in any written work, including publications, without the written consent of sponsor.
Publication restrictions are in place

Restriction type: OTHER