Trial Outcomes & Findings for A Study of Gefapixant (MK-7264) in Japanese Adult Participants With Refractory or Unexplained Chronic Cough (MK-7264-038) (NCT NCT03696108)

Last Updated: 2021-11-01

Results Overview

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

175 participants

Primary outcome timeframe

Up to 54 Weeks

Results posted on

2021-11-01

Participant Flow

A total of 175 participants were originally enrolled in the study. 6 participants at one site were excluded from all analyses, including disposition, due to good clinical practice (GCP) noncompliance at the study site.

Participant milestones

Participant milestones
Measure	Gefapixant 15 mg BID Participants received a gefapixant 15 mg tablet and a placebo tablet to match gefapixant 45 mg twice daily (BID) for 52 weeks	Gefapixant 45 mg BID Participants received a gefapixant 45 mg tablet and a placebo tablet to match gefapixant 15 mg BID for 52 weeks
Overall Study STARTED	84	85
Overall Study COMPLETED	80	79
Overall Study NOT COMPLETED	4	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Gefapixant 15 mg BID Participants received a gefapixant 15 mg tablet and a placebo tablet to match gefapixant 45 mg twice daily (BID) for 52 weeks	Gefapixant 45 mg BID Participants received a gefapixant 45 mg tablet and a placebo tablet to match gefapixant 15 mg BID for 52 weeks
Overall Study Physician Decision	1	0
Overall Study Withdrawal by Subject	3	6

Baseline Characteristics

A Study of Gefapixant (MK-7264) in Japanese Adult Participants With Refractory or Unexplained Chronic Cough (MK-7264-038)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gefapixant 15 mg BID n=84 Participants Participants received a gefapixant 15 mg tablet and a placebo tablet to match gefapixant 45 mg twice daily (BID) for 52 weeks	Gefapixant 45 mg BID n=85 Participants Participants received a gefapixant 45 mg tablet and a placebo tablet to match gefapixant 15 mg BID for 52 weeks	Total n=169 Participants Total of all reporting groups
Age, Continuous	58.2 Years STANDARD_DEVIATION 14.1 • n=5 Participants	57.6 Years STANDARD_DEVIATION 15.8 • n=7 Participants	57.9 Years STANDARD_DEVIATION 15.0 • n=5 Participants
Sex: Female, Male Female	55 Participants n=5 Participants	51 Participants n=7 Participants	106 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	34 Participants n=7 Participants	63 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	84 Participants n=5 Participants	85 Participants n=7 Participants	169 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	84 Participants n=5 Participants	85 Participants n=7 Participants	169 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 54 Weeks

Population: All randomized participants who received at least one dose of study treatment.

Outcome measures

Outcome measures
Measure	Gefapixant 15 mg BID n=84 Participants Participants received a gefapixant 15 mg tablet and a placebo tablet to match gefapixant 45 mg BID for 52 weeks	Gefapixant 45 mg n=85 Participants Participants received a gefapixant 45 mg tablet and a placebo tablet to match gefapixant 15 mg BID for 52 weeks
Number of Participants Who Experienced at Least One Adverse Event (AE)	79 Participants	82 Participants

PRIMARY outcome

Timeframe: Up to 52 Weeks

Population: All randomized participants who received at least one dose of study treatment.

Outcome measures

Outcome measures
Measure	Gefapixant 15 mg BID n=84 Participants Participants received a gefapixant 15 mg tablet and a placebo tablet to match gefapixant 45 mg BID for 52 weeks	Gefapixant 45 mg n=85 Participants Participants received a gefapixant 45 mg tablet and a placebo tablet to match gefapixant 15 mg BID for 52 weeks
Number of Participants Who Discontinued Study Drug Due to an AE	6 Participants	17 Participants

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: All randomized participants who have taken at least one dose of study treatment and provided at least one baseline and one post-baseline endpoint observations during the treatment period.

The LCQ is a 19-item cough-specific health-related quality of life (HRQoL) questionnaire which contains three domains (physical, psychological and social), calculated as a mean score for each domain ranging from 1 to 7 and total score ranging from 3 to 21. Each item on the LCQ is assessed using a 7-point Likert scale ranging from 1 to 7. Higher scores indicate better HRQoL. The least squares mean of the change from baseline is based on a longitudinal analysis of covariance (ANCOVA) model.

Outcome measures

Outcome measures
Measure	Gefapixant 15 mg BID n=84 Participants Participants received a gefapixant 15 mg tablet and a placebo tablet to match gefapixant 45 mg BID for 52 weeks	Gefapixant 45 mg n=85 Participants Participants received a gefapixant 45 mg tablet and a placebo tablet to match gefapixant 15 mg BID for 52 weeks
Change From Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 12	1.4 Scores on a Scale Interval 0.7 to 2.0	0.9 Scores on a Scale Interval 0.3 to 1.6

SECONDARY outcome

Timeframe: Baseline, up to 52 Weeks

Population: All randomized participants who have taken at least one dose of study treatment and provided at least one baseline and one post-baseline endpoint observations during the treatment period.

The LCQ is a 19-item cough-specific HRQoL questionnaire which contains three domains (physical, psychological and social), calculated as a mean score for each domain ranging from 1 to 7 and total score ranging from 3 to 21. Each item on the LCQ is assessed using a 7-point Likert scale ranging from 1 to 7. Higher scores indicate better HRQoL. The least squares mean of the change from baseline is based on a longitudinal analysis of covariance (ANCOVA) model at weeks 4, 8, 12, 24, 38 and 52 of treatment.

Outcome measures

Outcome measures
Measure	Gefapixant 15 mg BID n=84 Participants Participants received a gefapixant 15 mg tablet and a placebo tablet to match gefapixant 45 mg BID for 52 weeks	Gefapixant 45 mg n=85 Participants Participants received a gefapixant 45 mg tablet and a placebo tablet to match gefapixant 15 mg BID for 52 weeks
Change From Baseline in LCQ Total Score Week 8	1.5 Scores on a Scale Interval 0.8 to 2.1	1.2 Scores on a Scale Interval 0.6 to 1.9
Change From Baseline in LCQ Total Score Week 4	0.9 Scores on a Scale Interval 0.2 to 1.5	0.8 Scores on a Scale Interval 0.2 to 1.4
Change From Baseline in LCQ Total Score Week 12	1.4 Scores on a Scale Interval 0.7 to 2.0	0.9 Scores on a Scale Interval 0.3 to 1.6
Change From Baseline in LCQ Total Score Week 24	1.6 Scores on a Scale Interval 0.9 to 2.2	1.1 Scores on a Scale Interval 0.4 to 1.8
Change From Baseline in LCQ Total Score Week 38	1.8 Scores on a Scale Interval 1.1 to 2.4	1.2 Scores on a Scale Interval 0.6 to 1.9
Change From Baseline in LCQ Total Score Week 52	2.3 Scores on a Scale Interval 1.6 to 2.9	1.5 Scores on a Scale Interval 0.8 to 2.1

SECONDARY outcome

Timeframe: Baseline, Up to 52 Weeks

Population: All randomized participants who have taken at least one dose of study treatment and provided at least one baseline and one post-baseline endpoint observations during the treatment period.

The LCQ is a 19-item cough-specific HRQoL questionnaire which contains three domains (physical, psychological and social), calculated as a mean score for each domain ranging from 1 to 7 and total score ranging from 3 to 21. Each item on the LCQ is assessed using a 7-point Likert scale ranging from 1 to 7. Higher scores indicate better HRQoL. A clinically meaningful improvement from baseline in HRQoL was defined as ≥1.3-point increase in the LCQ total score at weeks 4, 8, 12, 24, 38 and 52 of treatment.

Outcome measures

Outcome measures
Measure	Gefapixant 15 mg BID n=84 Participants Participants received a gefapixant 15 mg tablet and a placebo tablet to match gefapixant 45 mg BID for 52 weeks	Gefapixant 45 mg n=85 Participants Participants received a gefapixant 45 mg tablet and a placebo tablet to match gefapixant 15 mg BID for 52 weeks
Percentage of Participants With a ≥1.3 Point Change From Baseline in the LCQ Total Score Week 38	56.1 Percentage of Participants	44.9 Percentage of Participants
Percentage of Participants With a ≥1.3 Point Change From Baseline in the LCQ Total Score Week 4	38.1 Percentage of Participants	36.5 Percentage of Participants
Percentage of Participants With a ≥1.3 Point Change From Baseline in the LCQ Total Score Week 8	43.4 Percentage of Participants	43.2 Percentage of Participants
Percentage of Participants With a ≥1.3 Point Change From Baseline in the LCQ Total Score Week 12	48.2 Percentage of Participants	40.7 Percentage of Participants
Percentage of Participants With a ≥1.3 Point Change From Baseline in the LCQ Total Score Week 24	53.7 Percentage of Participants	45.7 Percentage of Participants
Percentage of Participants With a ≥1.3 Point Change From Baseline in the LCQ Total Score Week 52	58.8 Percentage of Participants	46.8 Percentage of Participants

Adverse Events

Gefapixant 15 mg

Serious events: 2 serious events

Other events: 73 other events

Deaths: 0 deaths

Gefapixant 45 mg

Serious events: 10 serious events

Other events: 76 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Gefapixant 15 mg n=84 participants at risk Participants received a gefapixant 15 mg tablet and a placebo tablet to match gefapixant 45 mg twice daily (BID) for 52 weeks	Gefapixant 45 mg n=85 participants at risk Participants received a gefapixant 45 mg tablet and a placebo tablet to match gefapixant 15 mg BID for 52 weeks
Gastrointestinal disorders Large intestine polyp	0.00% 0/84 • Up to approximately 54 weeks The all-cause mortality, serious adverse events, and other adverse events population includes all randomized participants who received at least one dose of study treatment, with participants included in the treatment group corresponding to the study treatment they actually received.	1.2% 1/85 • Number of events 1 • Up to approximately 54 weeks The all-cause mortality, serious adverse events, and other adverse events population includes all randomized participants who received at least one dose of study treatment, with participants included in the treatment group corresponding to the study treatment they actually received.
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/84 • Up to approximately 54 weeks The all-cause mortality, serious adverse events, and other adverse events population includes all randomized participants who received at least one dose of study treatment, with participants included in the treatment group corresponding to the study treatment they actually received.	1.2% 1/85 • Number of events 1 • Up to approximately 54 weeks The all-cause mortality, serious adverse events, and other adverse events population includes all randomized participants who received at least one dose of study treatment, with participants included in the treatment group corresponding to the study treatment they actually received.
Infections and infestations Bronchitis	1.2% 1/84 • Number of events 1 • Up to approximately 54 weeks The all-cause mortality, serious adverse events, and other adverse events population includes all randomized participants who received at least one dose of study treatment, with participants included in the treatment group corresponding to the study treatment they actually received.	0.00% 0/85 • Up to approximately 54 weeks The all-cause mortality, serious adverse events, and other adverse events population includes all randomized participants who received at least one dose of study treatment, with participants included in the treatment group corresponding to the study treatment they actually received.
Infections and infestations Pneumonia	0.00% 0/84 • Up to approximately 54 weeks The all-cause mortality, serious adverse events, and other adverse events population includes all randomized participants who received at least one dose of study treatment, with participants included in the treatment group corresponding to the study treatment they actually received.	3.5% 3/85 • Number of events 3 • Up to approximately 54 weeks The all-cause mortality, serious adverse events, and other adverse events population includes all randomized participants who received at least one dose of study treatment, with participants included in the treatment group corresponding to the study treatment they actually received.
Infections and infestations Pneumonia bacterial	1.2% 1/84 • Number of events 1 • Up to approximately 54 weeks The all-cause mortality, serious adverse events, and other adverse events population includes all randomized participants who received at least one dose of study treatment, with participants included in the treatment group corresponding to the study treatment they actually received.	0.00% 0/85 • Up to approximately 54 weeks The all-cause mortality, serious adverse events, and other adverse events population includes all randomized participants who received at least one dose of study treatment, with participants included in the treatment group corresponding to the study treatment they actually received.
Injury, poisoning and procedural complications Radius fracture	0.00% 0/84 • Up to approximately 54 weeks The all-cause mortality, serious adverse events, and other adverse events population includes all randomized participants who received at least one dose of study treatment, with participants included in the treatment group corresponding to the study treatment they actually received.	1.2% 1/85 • Number of events 1 • Up to approximately 54 weeks The all-cause mortality, serious adverse events, and other adverse events population includes all randomized participants who received at least one dose of study treatment, with participants included in the treatment group corresponding to the study treatment they actually received.
Metabolism and nutrition disorders Hypophagia	0.00% 0/84 • Up to approximately 54 weeks The all-cause mortality, serious adverse events, and other adverse events population includes all randomized participants who received at least one dose of study treatment, with participants included in the treatment group corresponding to the study treatment they actually received.	1.2% 1/85 • Number of events 1 • Up to approximately 54 weeks The all-cause mortality, serious adverse events, and other adverse events population includes all randomized participants who received at least one dose of study treatment, with participants included in the treatment group corresponding to the study treatment they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.00% 0/84 • Up to approximately 54 weeks The all-cause mortality, serious adverse events, and other adverse events population includes all randomized participants who received at least one dose of study treatment, with participants included in the treatment group corresponding to the study treatment they actually received.	1.2% 1/85 • Number of events 1 • Up to approximately 54 weeks The all-cause mortality, serious adverse events, and other adverse events population includes all randomized participants who received at least one dose of study treatment, with participants included in the treatment group corresponding to the study treatment they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian germ cell teratoma benign	0.00% 0/84 • Up to approximately 54 weeks The all-cause mortality, serious adverse events, and other adverse events population includes all randomized participants who received at least one dose of study treatment, with participants included in the treatment group corresponding to the study treatment they actually received.	1.2% 1/85 • Number of events 1 • Up to approximately 54 weeks The all-cause mortality, serious adverse events, and other adverse events population includes all randomized participants who received at least one dose of study treatment, with participants included in the treatment group corresponding to the study treatment they actually received.
Nervous system disorders Embolic cerebral infarction	0.00% 0/84 • Up to approximately 54 weeks The all-cause mortality, serious adverse events, and other adverse events population includes all randomized participants who received at least one dose of study treatment, with participants included in the treatment group corresponding to the study treatment they actually received.	1.2% 1/85 • Number of events 1 • Up to approximately 54 weeks The all-cause mortality, serious adverse events, and other adverse events population includes all randomized participants who received at least one dose of study treatment, with participants included in the treatment group corresponding to the study treatment they actually received.
Respiratory, thoracic and mediastinal disorders Asthma	2.4% 2/84 • Number of events 2 • Up to approximately 54 weeks The all-cause mortality, serious adverse events, and other adverse events population includes all randomized participants who received at least one dose of study treatment, with participants included in the treatment group corresponding to the study treatment they actually received.	0.00% 0/85 • Up to approximately 54 weeks The all-cause mortality, serious adverse events, and other adverse events population includes all randomized participants who received at least one dose of study treatment, with participants included in the treatment group corresponding to the study treatment they actually received.

Other adverse events

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 If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission.
Publication restrictions are in place

Restriction type: OTHER

Measure	Gefapixant 15 mg n=84 participants at risk Participants received a gefapixant 15 mg tablet and a placebo tablet to match gefapixant 45 mg twice daily (BID) for 52 weeks	Gefapixant 45 mg n=85 participants at risk Participants received a gefapixant 45 mg tablet and a placebo tablet to match gefapixant 15 mg BID for 52 weeks
Respiratory, thoracic and mediastinal disorders Cough	22.6% 19/84 • Number of events 34 • Up to approximately 54 weeks The all-cause mortality, serious adverse events, and other adverse events population includes all randomized participants who received at least one dose of study treatment, with participants included in the treatment group corresponding to the study treatment they actually received.	12.9% 11/85 • Number of events 22 • Up to approximately 54 weeks The all-cause mortality, serious adverse events, and other adverse events population includes all randomized participants who received at least one dose of study treatment, with participants included in the treatment group corresponding to the study treatment they actually received.
Gastrointestinal disorders Constipation	7.1% 6/84 • Number of events 6 • Up to approximately 54 weeks The all-cause mortality, serious adverse events, and other adverse events population includes all randomized participants who received at least one dose of study treatment, with participants included in the treatment group corresponding to the study treatment they actually received.	2.4% 2/85 • Number of events 2 • Up to approximately 54 weeks The all-cause mortality, serious adverse events, and other adverse events population includes all randomized participants who received at least one dose of study treatment, with participants included in the treatment group corresponding to the study treatment they actually received.
Gastrointestinal disorders Diarrhoea	8.3% 7/84 • Number of events 7 • Up to approximately 54 weeks The all-cause mortality, serious adverse events, and other adverse events population includes all randomized participants who received at least one dose of study treatment, with participants included in the treatment group corresponding to the study treatment they actually received.	2.4% 2/85 • Number of events 2 • Up to approximately 54 weeks The all-cause mortality, serious adverse events, and other adverse events population includes all randomized participants who received at least one dose of study treatment, with participants included in the treatment group corresponding to the study treatment they actually received.
Gastrointestinal disorders Gastrooesophageal reflux disease	7.1% 6/84 • Number of events 6 • Up to approximately 54 weeks The all-cause mortality, serious adverse events, and other adverse events population includes all randomized participants who received at least one dose of study treatment, with participants included in the treatment group corresponding to the study treatment they actually received.	1.2% 1/85 • Number of events 1 • Up to approximately 54 weeks The all-cause mortality, serious adverse events, and other adverse events population includes all randomized participants who received at least one dose of study treatment, with participants included in the treatment group corresponding to the study treatment they actually received.
Gastrointestinal disorders Paraesthesia oral	1.2% 1/84 • Number of events 1 • Up to approximately 54 weeks The all-cause mortality, serious adverse events, and other adverse events population includes all randomized participants who received at least one dose of study treatment, with participants included in the treatment group corresponding to the study treatment they actually received.	5.9% 5/85 • Number of events 5 • Up to approximately 54 weeks The all-cause mortality, serious adverse events, and other adverse events population includes all randomized participants who received at least one dose of study treatment, with participants included in the treatment group corresponding to the study treatment they actually received.
General disorders Pyrexia	6.0% 5/84 • Number of events 5 • Up to approximately 54 weeks The all-cause mortality, serious adverse events, and other adverse events population includes all randomized participants who received at least one dose of study treatment, with participants included in the treatment group corresponding to the study treatment they actually received.	7.1% 6/85 • Number of events 7 • Up to approximately 54 weeks The all-cause mortality, serious adverse events, and other adverse events population includes all randomized participants who received at least one dose of study treatment, with participants included in the treatment group corresponding to the study treatment they actually received.
Infections and infestations Bronchitis	11.9% 10/84 • Number of events 11 • Up to approximately 54 weeks The all-cause mortality, serious adverse events, and other adverse events population includes all randomized participants who received at least one dose of study treatment, with participants included in the treatment group corresponding to the study treatment they actually received.	3.5% 3/85 • Number of events 3 • Up to approximately 54 weeks The all-cause mortality, serious adverse events, and other adverse events population includes all randomized participants who received at least one dose of study treatment, with participants included in the treatment group corresponding to the study treatment they actually received.
Infections and infestations Gastroenteritis	2.4% 2/84 • Number of events 3 • Up to approximately 54 weeks The all-cause mortality, serious adverse events, and other adverse events population includes all randomized participants who received at least one dose of study treatment, with participants included in the treatment group corresponding to the study treatment they actually received.	7.1% 6/85 • Number of events 6 • Up to approximately 54 weeks The all-cause mortality, serious adverse events, and other adverse events population includes all randomized participants who received at least one dose of study treatment, with participants included in the treatment group corresponding to the study treatment they actually received.
Infections and infestations Nasopharyngitis	29.8% 25/84 • Number of events 60 • Up to approximately 54 weeks The all-cause mortality, serious adverse events, and other adverse events population includes all randomized participants who received at least one dose of study treatment, with participants included in the treatment group corresponding to the study treatment they actually received.	38.8% 33/85 • Number of events 61 • Up to approximately 54 weeks The all-cause mortality, serious adverse events, and other adverse events population includes all randomized participants who received at least one dose of study treatment, with participants included in the treatment group corresponding to the study treatment they actually received.
Infections and infestations Pharyngitis	9.5% 8/84 • Number of events 10 • Up to approximately 54 weeks The all-cause mortality, serious adverse events, and other adverse events population includes all randomized participants who received at least one dose of study treatment, with participants included in the treatment group corresponding to the study treatment they actually received.	4.7% 4/85 • Number of events 6 • Up to approximately 54 weeks The all-cause mortality, serious adverse events, and other adverse events population includes all randomized participants who received at least one dose of study treatment, with participants included in the treatment group corresponding to the study treatment they actually received.
Injury, poisoning and procedural complications Accidental overdose	6.0% 5/84 • Number of events 5 • Up to approximately 54 weeks The all-cause mortality, serious adverse events, and other adverse events population includes all randomized participants who received at least one dose of study treatment, with participants included in the treatment group corresponding to the study treatment they actually received.	3.5% 3/85 • Number of events 3 • Up to approximately 54 weeks The all-cause mortality, serious adverse events, and other adverse events population includes all randomized participants who received at least one dose of study treatment, with participants included in the treatment group corresponding to the study treatment they actually received.
Nervous system disorders Ageusia	0.00% 0/84 • Up to approximately 54 weeks The all-cause mortality, serious adverse events, and other adverse events population includes all randomized participants who received at least one dose of study treatment, with participants included in the treatment group corresponding to the study treatment they actually received.	5.9% 5/85 • Number of events 5 • Up to approximately 54 weeks The all-cause mortality, serious adverse events, and other adverse events population includes all randomized participants who received at least one dose of study treatment, with participants included in the treatment group corresponding to the study treatment they actually received.
Nervous system disorders Dysgeusia	16.7% 14/84 • Number of events 17 • Up to approximately 54 weeks The all-cause mortality, serious adverse events, and other adverse events population includes all randomized participants who received at least one dose of study treatment, with participants included in the treatment group corresponding to the study treatment they actually received.	47.1% 40/85 • Number of events 40 • Up to approximately 54 weeks The all-cause mortality, serious adverse events, and other adverse events population includes all randomized participants who received at least one dose of study treatment, with participants included in the treatment group corresponding to the study treatment they actually received.
Nervous system disorders Headache	10.7% 9/84 • Number of events 11 • Up to approximately 54 weeks The all-cause mortality, serious adverse events, and other adverse events population includes all randomized participants who received at least one dose of study treatment, with participants included in the treatment group corresponding to the study treatment they actually received.	3.5% 3/85 • Number of events 3 • Up to approximately 54 weeks The all-cause mortality, serious adverse events, and other adverse events population includes all randomized participants who received at least one dose of study treatment, with participants included in the treatment group corresponding to the study treatment they actually received.
Nervous system disorders Hypogeusia	10.7% 9/84 • Number of events 9 • Up to approximately 54 weeks The all-cause mortality, serious adverse events, and other adverse events population includes all randomized participants who received at least one dose of study treatment, with participants included in the treatment group corresponding to the study treatment they actually received.	16.5% 14/85 • Number of events 14 • Up to approximately 54 weeks The all-cause mortality, serious adverse events, and other adverse events population includes all randomized participants who received at least one dose of study treatment, with participants included in the treatment group corresponding to the study treatment they actually received.
Nervous system disorders Taste disorder	7.1% 6/84 • Number of events 6 • Up to approximately 54 weeks The all-cause mortality, serious adverse events, and other adverse events population includes all randomized participants who received at least one dose of study treatment, with participants included in the treatment group corresponding to the study treatment they actually received.	11.8% 10/85 • Number of events 10 • Up to approximately 54 weeks The all-cause mortality, serious adverse events, and other adverse events population includes all randomized participants who received at least one dose of study treatment, with participants included in the treatment group corresponding to the study treatment they actually received.
Psychiatric disorders Insomnia	1.2% 1/84 • Number of events 1 • Up to approximately 54 weeks The all-cause mortality, serious adverse events, and other adverse events population includes all randomized participants who received at least one dose of study treatment, with participants included in the treatment group corresponding to the study treatment they actually received.	5.9% 5/85 • Number of events 5 • Up to approximately 54 weeks The all-cause mortality, serious adverse events, and other adverse events population includes all randomized participants who received at least one dose of study treatment, with participants included in the treatment group corresponding to the study treatment they actually received.
Respiratory, thoracic and mediastinal disorders Asthma	11.9% 10/84 • Number of events 15 • Up to approximately 54 weeks The all-cause mortality, serious adverse events, and other adverse events population includes all randomized participants who received at least one dose of study treatment, with participants included in the treatment group corresponding to the study treatment they actually received.	7.1% 6/85 • Number of events 9 • Up to approximately 54 weeks The all-cause mortality, serious adverse events, and other adverse events population includes all randomized participants who received at least one dose of study treatment, with participants included in the treatment group corresponding to the study treatment they actually received.